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A cancer diagnosis affects not only patients but also their caregivers. The purpose of this study is to test the feasibility of using a mobile app suite, IntelliCare, to improve the mental health of cancer patients and caregivers.
Cancer patients and/or their caregivers will receive access to the mobile app suite, IntelliCare, as well as phone coaching that will focus on how to use the apps. IntlliCare is composed of separate apps that each target a specific aspect of mental health (e.g., reducing worry). The apps are interactive and designed for users to engage in short time bursts (e.g., less than a minute). IntelliCare was originally designed to be paired with phone coaching that focuses on how to use the apps and overcome barriers to usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IntelliCare + Phone Coaching | Experimental | Participants will receive IntelliCare apps with phone coaching for 7 weeks. In this arm, participants will pick two IntelliCare apps to use every week. Participants will receive a phone coaching call before they use the apps, for approximately 30 minutes, as well as 3 weeks after initiating app use (10 minute call). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntelliCare + Phone Coaching | Behavioral | IntelliCare is composed of 13 separate, native apps. Each app targets a specific aspect of mental health (e.g., reducing worry, increasing social support, tracking negative thoughts). The apps are available to the public in both Android and iPhone stores. Participants will be asked to try two new IntelliCare apps every week, for 7 weeks. Phone coaching will occur at Day 0, before using any of the apps, and the third week of app usage. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Symptoms | Patient-Reported Outcomes Measurement Information System 4-Item Depression Scale (from 29-item Profile), measures depression on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of depression. | Change in depression symptoms from baseline to post-intervention (7 weeks after baseline) |
| Anxiety Symptoms | Patient-Reported Outcomes Measurement Information System 4-Item Anxiety Scale (from 29-item Profile), measures anxiety on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of anxiety. | Change in anxiety symptoms from baseline to post-intervention (7 weeks after baseline) |
| Clinical Mood Symptoms | Patient Health Questionnaire-4 contains measures clinical symptoms of mood and anxiety disorders. Scores on this scale range from 0-12, with a higher score indicating greater severity of mood symptoms. Unlike the Patient-Reported Outcomes Measurement Information System scales, this scale has pre-determined clinical cutoffs for mild, moderate, and severe symptoms, which will be used to classify severity of mood symptoms. | Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | Patient-Reported Outcomes Measurement Information System 4-Item Physical Function Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating less impairment of physical function. | Change in physical function from baseline to post-intervention (7 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Mood | Overall, how have you felt over the past week? (Scale from 1=Very negative to 5=Very positive) | Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Drug Use |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Chow, PhD | Contact | 434-924-5401 | pic2u@virignia.edu | |
| Sarah Adams, BA | Contact | 434-243-4239 | SA4FA@hscmail.mcc.virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Philip Chow, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31344674 | Derived | Chow PI, Showalter SL, Gerber MS, Kennedy E, Brenin DR, Schroen AT, Mohr DC, Lattie EG, Cohn WF. Use of Mental Health Apps by Breast Cancer Patients and Their Caregivers in the United States: Protocol for a Pilot Pre-Post Study. JMIR Res Protoc. 2019 Jan 14;8(1):e11452. doi: 10.2196/11452. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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|
| Life Meaning/purpose |
Patient-Reported Outcomes Measurement Information System 4-Item Life Meaning and Purpose Scale. Scores on this scale range from 4-20, with a higher score indicating more life meaning and purpose. |
| Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline) |
| Sleep Quality | Patient-Reported Outcomes Measurement Information System 4-Item Sleep Disturbance Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more sleep disturbance. | Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline) |
| Fatigue | Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more fatigue. | Change in fatigue from baseline to post-intervention (7 weeks after baseline) |
| Pain Interference | Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more pain interference in daily life. | Change in Pain Interference from baseline to post-intervention (7 weeks after baseline) |
| Patient Health Care Utilization | Created a scale since none currently exist. Items (in order) are the following:
| Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline) |
| Caregiver Health Care Utilization | Created a scale since none currently exist. Items (in order) are the following:
| Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline) |
| Ability to Participate in Social Roles and Activities | Patient-Reported Outcomes Measurement Information System 4-Item Ability to Participate in Social Roles and Activities Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more ability to participate in social roles and activities in daily life. | Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline) |
| Caregiver Self-Efficacy | Caregiver Self-Efficacy Scale (CaSES; Ugalde, Krishnasamy, & Schofield, 2013). A 21-item scale developed to measure self-efficacy in informal cancer caregivers. Scores range from 0-84, with a higher score indicating more self-efficacy. | Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline) |
How much have you used alcohol or tobacco to cope with negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)
| Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Pain | How much physical pain have you experienced? (Scale from 1=Not at all to 5=A lot or extremely) | Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Social Connectedness |
| Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Anhedonia | How much interest or pleasure did you have in doing things? (Scale from 1=Not at all to 5=A lot or extremely) | Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Anxiety | How much did you feel nervous, anxious, or on edge? (Scale from 1=Not at all to 5=A lot or extremely) | Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Physical Activity | How active were you? (Scale from 1=Not at all to 5=A lot or extremely) | Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Emotion Regulation | How well have you managed negative feelings? (Scale from 1=Not at all to 5=A lot or extremely) | Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |
| Future Positive and Negative Mood | Overall, how do you expect to feel next week? (Scale from 1=Very negative to 5=Very positive) | Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 |