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| ID | Type | Description | Link |
|---|---|---|---|
| 1R37CA248434-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| National Cancer Institute (NCI) | NIH |
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The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IntelliCare | Experimental | IntelliCare is a self-guided, fully automated suite of apps designed for brief, frequent check-ins to promote skill acquisition. IntelliCare has been shown in both general deployment and human-supported trials to be efficacious in reducing symptoms of depression and anxiety. |
|
| Patient Education | Active Comparator | The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntelliCare | Behavioral | IntelliCare is a self-guided, fully automated suite of 6 apps designed for brief, frequent check-ins to promote skill acquisition. IntelliCare has been shown in both general deployment and human-supported trials to be efficacious in reducing symptoms of depression and anxiety. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Baseline |
| Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Post 8 weeks |
| Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | 6 month follow up |
| Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | 12 month follow up |
| Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Baseline |
| Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Post 8 weeks |
| Generalized Anxiety Disorder-7 |
| Measure | Description | Time Frame |
|---|---|---|
| App Engagement From App Sessions | Frequency of unique app sessions from Baseline through 8 weeks based on median number of app sessions | Frequency of unique app sessions from Baseline through 8 weeks |
| App Engagement From App Session Duration |
| Measure | Description | Time Frame |
|---|---|---|
| Digital Intervention Evaluation Questionnaire | A 12-item questionnaire with subscales of perceived utility and perceived impact of digital interventions. Each item is rated on a 0 (not at all) to 5 (very) scale and the items are summed to compute a total score ranging from 0-60. Higher scores indicate higher perceived utility and impact of a digital intervention. | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
Eligibility is not based on self-representation of gender identity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
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3 participants withdrew from the study shortly after being randomized to IntelliCare and never accessed the program. They are therefore not included in any IntelliCare subgroups (i.e., IntelliCare - High Engager, No Coaching; IntelliCare - Low Engager, No Coaching; IntelliCare - Low Engager, Coaching). Subgroup assignment is based on participant engagement with IntelliCare, and because these participants withdrew before engaging with the program, they do not fit into any IntelliCare subgroup.
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| ID | Title | Description |
|---|---|---|
| FG000 | IntelliCare - High Engager, No Coaching | This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual. |
| FG001 | IntelliCare - Low Engager, No Coaching | This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual. |
| FG002 | IntelliCare - Low Engager, Coaching | This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach. |
| FG003 | Patient Education | The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps. Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 3 enrolled participants who withdrew shortly after being randomized to IntelliCare and never accessed the program. They are not included in any of the IntelliCare subgroups because they were not able to be categorized as high or low engagers.
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| ID | Title | Description |
|---|---|---|
| BG000 | IntelliCare - High Engager, No Coaching | This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
through study completion, up to 1 year
Adverse Event: an undesirable and unintended result of therapy, intervention or interaction experienced by a subject participating in a research study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IntelliCare - High Engager, No Coaching | This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual. |
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Technical problems led to not being able to extract app engagement based on app session duration and number of app downloads from any participants. The TWente Engagement With Ehealth Technologies Scale (TWEETS) was not administered as it was redundant with the other intervention evaluation and adherence measures. These have been recorded in the Results by including "0" participants analyzed and providing an explanation in the Analysis Population Description for why data cannot be reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip Chow | University of Virginia | 9146453458 | pic2u@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2021 | Feb 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2024 | Feb 17, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2021 | Feb 17, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D010358 | Patient Participation |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010342 | Patient Acceptance of Health Care |
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Sequential, Multiple Assignment, Randomized Trial (SMART)
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| Psychoeducation | Behavioral | The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms. |
|
| Coaching | Behavioral | The randomization of added coaching vs. no added coaching after 1 week will only be carried out in the IntelliCare group. Coaching is a human supported approach to optimizing the use and benefit of the IntelliCare apps. |
|
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. |
| 6 month follow up |
| Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | 12 month follow up |
Duration in seconds of app sessions from Baseline through 8 weeks
| Duration in seconds of app sessions from Baseline through 8 weeks |
| App Engagement From App Downloads | Number of apps downloaded from Baseline through 8 weeks | Number of apps downloaded from Baseline through 8 weeks |
| 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Baseline |
| 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 8 week |
| 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 6 months |
| 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 12 months |
| 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Baseline |
| 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 8 weeks |
| 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 6 months |
| 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 12 months |
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | Baseline |
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | 8 weeks |
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | 6 months |
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | 12 months |
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | Baseline |
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | 8 weeks |
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | 6 months |
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | 12 months |
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Baseline |
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | 8 weeks |
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | 6 months |
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | 12 months |
| PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | Baseline |
| PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | 8 weeks |
| PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | 6 months |
| PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | 12 months |
| PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | Baseline |
| PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | 8 weeks |
| PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | 6 months |
| PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | 12 months |
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | Baseline |
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | 8 weeks |
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | 6 months |
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | 12 months |
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | Baseline |
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | 8 weeks |
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | 6 months |
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | 12 months |
| Ten Item Personality Inventory- Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | Baseline |
| Ten Item Personality Inventory - Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | 8 weeks |
| Ten Item Personality Inventory - Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | 6 months |
| Ten Item Personality Inventory - Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | 12 months |
| Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | Baseline |
| Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | 8 weeks |
| Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | 6 months |
| Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | 12 months |
| Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | Baseline |
| Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | 8 weeks |
| Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | 6 months |
| Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | 12 months |
| Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | Baseline |
| Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | 8 weeks |
| Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | 6 months |
| Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | 12 months |
| Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | Baseline |
| Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | 8 weeks |
| Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | 6 months |
| Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | 12 months |
| TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | Baseline |
| TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | 8 weeks |
| TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | 6 months |
| TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | 12 months |
| Digital Intervention Adherence Questionnaire | A 26 item questionnaire that assesses perceived adherence to a digital intervention due to barriers to use. Each item is scored on a 0 (not at all) to 2 (very) scale and the items are summed to compute a total score ranging from 0-52. Higher scores indicate lower perceived adherence to a digital intervention due to barriers to use. | 8 weeks |
| IntelliCare - Low Engager, No Coaching |
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual. |
| BG002 | IntelliCare - Low Engager, Coaching | This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach. |
| BG003 | Patient Education | The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps. Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms. |
| BG004 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual. |
| OG002 | IntelliCare - Low Engager, Coaching | This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach. |
| OG003 | Patient Education | The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps. Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms. |
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| Primary | Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | Post 8 weeks |
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| Primary | Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | 6 month follow up |
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| Primary | Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | 12 month follow up |
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| Primary | Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | Post 8 weeks |
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| Primary | Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | 6 month follow up |
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| Primary | Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure | Posted | Mean | Standard Deviation | score on a scale | 12 month follow up |
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| Secondary | App Engagement From App Sessions | Frequency of unique app sessions from Baseline through 8 weeks based on median number of app sessions | Includes only participants who downloaded their assigned app or intervention. | Posted | Median | Inter-Quartile Range | app sessions | Frequency of unique app sessions from Baseline through 8 weeks |
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| Secondary | App Engagement From App Session Duration | Duration in seconds of app sessions from Baseline through 8 weeks | Technical problems led to not being able to extract app engagement based on app session duration from any participants. Data related to the gold standard metric of number of app sessions was captured and reported. | Posted | Duration in seconds of app sessions from Baseline through 8 weeks |
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| Secondary | App Engagement From App Downloads | Number of apps downloaded from Baseline through 8 weeks | Technical problems led to not being able to extract app engagement based on number of app downloads from any participants. Data related to the gold standard metric of number of app sessions was captured and reported. | Posted | Number of apps downloaded from Baseline through 8 weeks |
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| Secondary | 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | 8 week |
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| Secondary | 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 36-Item Short Form Survey - Physical Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 36-Item Short Form Survey - Mental Health | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | Posted | Mean | Standard Deviation | T-score | Baseline |
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| Secondary | PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | Posted | Mean | Standard Deviation | T-score | 8 weeks |
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| Secondary | PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | Posted | Mean | Standard Deviation | T-score | 6 months |
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| Secondary | PROMIS Global Mental Health v1.2 | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. | Posted | Mean | Standard Deviation | T-score | 12 months |
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| Secondary | PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | PROMIS Satisfaction With Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Ten Item Personality Inventory- Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Ten Item Personality Inventory - Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Ten Item Personality Inventory - Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Ten Item Personality Inventory - Extraversion | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Ten Item Personality Inventory - Agreeableness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Ten Item Personality Inventory - Conscientiousness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Ten Item Personality Inventory - Neuroticism | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Ten Item Personality Inventory - Openness | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden. | Posted | Baseline |
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| Secondary | TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden. | Posted | 8 weeks |
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| Secondary | TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden. | Posted | 6 months |
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| Secondary | TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden. | Posted | 12 months |
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| Other Pre-specified | Digital Intervention Evaluation Questionnaire | A 12-item questionnaire with subscales of perceived utility and perceived impact of digital interventions. Each item is rated on a 0 (not at all) to 5 (very) scale and the items are summed to compute a total score ranging from 0-60. Higher scores indicate higher perceived utility and impact of a digital intervention. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Other Pre-specified | Digital Intervention Adherence Questionnaire | A 26 item questionnaire that assesses perceived adherence to a digital intervention due to barriers to use. Each item is scored on a 0 (not at all) to 2 (very) scale and the items are summed to compute a total score ranging from 0-52. Higher scores indicate lower perceived adherence to a digital intervention due to barriers to use. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Post-Hoc | Limited List of Questions for Exit Interview | The purpose of collecting this data was to explore how the intervention could be improved upon in future trials. Only those that receive the IntelliCare apps will be administered a qualitative interview that contains items assessing how the app intervention met their needs as a breast cancer survivor and possible changes to improve fit. Study staff will administer this interview on the phone and manually type in the participant responses during the interview. 10 questions will assess overall impressions of the IntelliCare app program to inform how it could be improved upon for future trials. When new data no longer adds new information or a new theme to the analysis, the theme is considered sufficiently explored and important. A numerical threshold for theme importance in qualitative analysis is not important, as this can lead to losing valuable, nuanced insights. | The data collected were qualitative based on interviews with participants who received IntelliCare. The "Patient Education" participants did not receive the Intellicare App. The count of participants that endorsed each theme is provided, however, it is important to stress that the goal was to identify meaningful patterns and concepts within the data, not just count how many people mention a theme. | Posted | Count of Participants | Participants | 8 weeks |
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| 1 |
| 137 |
| 0 |
| 137 |
| 0 |
| 137 |
| EG001 | IntelliCare - Low Engager, No Coaching | This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual. | 0 | 38 | 0 | 38 | 0 | 38 |
| EG002 | IntelliCare - Low Engager, Coaching | This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG003 | Patient Education | The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps. Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms. | 2 | 104 | 0 | 104 | 0 | 104 |
Not provided
Not provided
| D000074822 |
| Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Week 2 |
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| Week 4 |
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| Week 8 |
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| Make loading pictures easier |
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| Create a progress report for users as they use the app over time |
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| Include cancer related examples in the activities in the app to make them more relatable |
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| Have a way for users to connect with one another directly to provide emotional support |
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| Want more variety of activities and exercises to choose from to learn additional skills |
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