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| ID | Type | Description | Link |
|---|---|---|---|
| 1K08CA245107-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Symptom interference is common for survivors of young adult cancer (aged 18-39 at diagnosis) and impacts their abilities to achieve normative life goals (e.g., education, careers, independence, romantic/social relationships) as well as adhere to recommended follow-up care. Assistance with symptom management has been rated by young adult survivors as an important and unmet healthcare need; however, skill-based symptom management interventions have typically been tested among older cancer survivors and have not targeted the unique developmental needs of those diagnosed as young adults. The proposed research advances the health and wellbeing of young adult cancer survivors by creating a developmentally appropriate hybrid in-person/mHealth behavioral symptom management intervention which addresses variables (i.e., symptoms and symptom interference) consistently linked to significant social, economic, and health burden.
More than 60,000 young adults (YAs) aged 18-39 are diagnosed with cancer in the US each year. Advances in treatment have yielded five year survival rates >70% suggesting that the majority of YAs will become long-term cancer survivors. Symptom (e.g., pain, fatigue, distress) interference is common for YA cancer survivors and impacts their abilities to achieve normative life goals (e.g., returning to work/school, achieving autonomy, pursuing social/romantic relationships) and adhere to recommended follow-up care. Symptom management has been identified as a significant issue in the transition to survivorship for YAs by the Institute of Medicine and National Cancer Institute, and assistance with symptom management is rated as an important and unmet need by YA survivors. Yet, behavioral symptom management interventions have not targeted the needs of those diagnosed as YAs. The proposed study aims to develop and test the feasibility and acceptability of a novel behavioral symptom management intervention designed for survivors of YA cancer (cancer types: hematologic, breast, or gastrointestinal cancers, melanoma, or germ cell tumors). The hybrid intervention will include inperson, group sessions and an integrated mobile application. The intervention will provide peer support while also teaching skills to improve symptoms, symptom interference, and self-efficacy for symptom management. The mobile application will assist with symptom monitoring, home skills practice, and connecting with group members. The preliminary version of the intervention will be guided by the research team's prior work developing and testing symptom management interventions for cancer survivors, national guidelines for YA oncology, consultation with an expert advisory board, and input from patient (n=20) and provider N=10) stakeholders. The intervention will be further refined following review by patient user testers (n=10). Next, feasibility, acceptability, and distributions of change over time as well as relationships between outcome variables will be examined through a pilot randomized clinical trial of the developed intervention. Participants (N=60) will be randomized to intervention or wait-list control arms. Primary study outcomes are symptom (pain, fatigue, distress) severity and symptom interference. Self-efficacy and support will also be examined as mediators of change in outcome variables. The proposed study has the potential to make several significant contributions by targeting an underserved group of cancer survivors, addressing a critical gap in care, and addressing variables consistently linked to social, economic, and health burden for YAs. It will also provide important information about approaches to identify, recruit, and retain YA cancer survivors in research and provide pilot data for a larger trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Experimental | The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms. |
|
| Waitlist Control | Active Comparator | Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Behavioral | The intervention includes group sessions held over Zoom along with an integrated mobile application to provide participants with instruction in cognitive and behavioral strategies for managing symptoms (i.e., pain, fatigue, distress). The developed intervention includes 8 face-to-face group sessions (12 therapy hours). Sessions are delivered using a faded contact approach (i.e., sessions 1-6: weekly, sessions 7-8: biweekly). Participants receive secure access to a study-specific mobile application that includes: 1) audio and video files and brief text-based educational content reviewing strategies discussed during the groups; 2) the ability to self-monitor symptom severity; 3) the ability to connect with group members via a social networking platform; and 4) activity tracking synchronization. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Intervention satisfaction will be assessed using the Satisfaction witth Therapy and Therapist Scale-Revised, a 13-item measure with the first 12-items on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly agree." The 13th item (Global Improvement) asks, "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" (1) to "made things a lot worse" (5). Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater overall satisfaction. A total score is calculated as the sum of the first twelve items, with possible scores from 12 to 60, with higher scores indicating greater overall satisfaction. | Following completion of the intervention, up to 12 months |
| Number of Participants Who Completed Open-Ended Questions About the Program | Intervention will be evaluated using 3 open-ended questions, including the following: "1) What was the most helpful part of the program?," "2) What was the least helpful part of the program?", and "3) What suggestions do you have for us to help improve the program?" | Following completion of the intervention, up to 12 months |
| Percentage of Sessions Attended by Each Participant | Treatment feasibility will be assessed by measuring the session attendance rate for each participant. | Following completion of the intervention, up to 12 months |
| Treatment Acceptability Questionnaire | The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged. | Following completion of the intervention, up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms: PROMIS Depression Short Form | Depressive Symptoms will be assessed using the Patient Reported Outcomes Measurement Information System Depression Short Form-8a, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always." Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of depression. T-scores of 55 to 60 indicate mild levels of depression, 60 to 70 indicates moderate levels of depression, and greater than 70 indicate severe levels of depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activity: International Physical Activity Questionnaire | The International Physical Activity Questionnaire is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
Young Adult Cancer Survivors Participating in Intervention Development Interviews
Eligibility Criteria
Exclusion Criteria
Medical Providers Participating in Intervention Development Interviews Eligibility criteria
o Provide care to young adult cancer survivors at the Duke Cancer Institute
Young Adult Cancer Survivor User Testers
Eligibility Criteria
Exclusion Criteria
RCT Participants
Eligibility Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline S Dorfman | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38851732 | Derived | Dorfman CS, Shelby RA, Stalls JM, Thomas SM, Arrato NA, Herold B, Somers TJ, Keefe FJ, Winger JG, Vilardaga JP, Oeffinger K. Improving symptom management for survivors of young adult cancer: rationale and study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Jun 8;10(1):87. doi: 10.1186/s40814-024-01510-7. | |
| 36178972 | Derived | Dorfman CS, Shelby RA, Stalls JM, Somers TJ, Keefe FJ, Vilardaga JP, Winger JG, Mitchell K, Ehren C, Oeffinger KC. Improving Symptom Management for Survivors of Young Adult Cancer: Development of a Novel Intervention. J Adolesc Young Adult Oncol. 2023 Aug;12(4):472-487. doi: 10.1089/jayao.2022.0100. Epub 2022 Sep 30. |
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Of 65 enrolled patients, 4 patients were excluded prior to randomization: two lost to follow up, one subject withdrawal, and one PI withdrawal due to disease progression.
Participants were recruited from a comprehensive cancer center.
| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Symptom Management for Young Adult Cancer Survivors | The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms. |
| FG001 | Waitlist Control | Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Waitlist Cross-over |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Symptom Management for Young Adult Cancer Survivors | The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Intervention satisfaction will be assessed using the Satisfaction witth Therapy and Therapist Scale-Revised, a 13-item measure with the first 12-items on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly agree." The 13th item (Global Improvement) asks, "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" (1) to "made things a lot worse" (5). Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater overall satisfaction. A total score is calculated as the sum of the first twelve items, with possible scores from 12 to 60, with higher scores indicating greater overall satisfaction. | Participants who completed at least one intervention session. | Posted | Mean | Standard Deviation | scores on a scale | Following completion of the intervention, up to 12 months |
|
From enrollment until end of follow-up, up to 12 months
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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 | Behavioral Symptom Management for Young Adult Cancer Survivors | The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Dorfman, PhD | Duke University School of Medicine | 919-416-3473 | caroline.dorfman@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2025 | May 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2022 | Jul 17, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| D005221 | Fatigue |
| D001943 | Breast Neoplasms |
| D008545 | Melanoma |
| D019337 | Hematologic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D004701 | Endocrine Gland Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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A two-arm, pilot RCT employing a wait-list control arm will be used. Six cohorts of YA survivors (n=10/cohort) are randomized within their cohort with equal allocation to the intervention or control arms. Randomization was stratified by gender.
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| Use of Intervention Strategies |
Participants' use of intervention strategies will be assessed using a measure developed specific to components of the proposed intervention. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 "not at all" to 5 "every day" will be used. |
| Following completion of the intervention, up to 12 months |
| Self-reported Use of the Mobile Application | Participants' use of the mobile application will be assessed using a measure developed specific to components of the proposed mobile application. Participants will be asked about how frequently they have used components of the mobile application outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 "not at all" to 5 "2 or more times a day" will be used. | Following completion of the intervention, up to 12 months |
| Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
| Change in Anxiety: PROMIS Anxiety Short Form | Symptoms of Anxiety will be assessed using the Patient Reported Outcomes Measurement Information System Anxiety Short Form-8a, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always". Total scores are then converted to T-scores. Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of anxiety. T-scores of 55 to 60 indicate mild levels of anxiety, 60 to 70 indicates moderate levels of anxiety, and greater than 70 indicate severe levels of anxiety. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
| Change in Symptom Interference: Illness Intrusiveness Rating Scale | Symptom interference will be assessed using the Illness Intrusiveness Rating Scale (IIRS). The IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation). Items are rated on a 7-point scale from 1 "not very much" to 7 "very much." The total score ranges from 7 to 91, where a higher score indicates greater interference. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
| Change in Pain: Brief Pain Inventory | The Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Participants rate their pain on a scale from 0 "no pain" to 10 "pain as bad as you can imagine." Pain severity is calculated as the average of four items assessing participants' worst, least, current, and average (in the last week) pain on a scale from 0 "no pain" to 10 "worst pain." Pain interference is computed as the average of seven items, which ask about the interference of pain across different life domains (e.g., general activity, mood, relations with other people). | Baseline and again 3, 6, 9, and 12 months following the baseline assessment; pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
| Change in Fatigue: PROMIS Fatigue Short Form | Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"). Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. A higher score indicates greater fatigue. T-scores of 55 to 60 indicate mild levels of fatigue, 60 to 70 indicates moderate levels of fatigue, and greater than 70 indicate severe levels of fatigue. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
| Change in Activity: Stanford Leisure-Time Activity Categorical Item (LCAT) | The Stanford LCAT is a categorical item that assesses the type of physical activities participants do. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT) | The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = "not at all" to 4 = "very much." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ) | The AAQ is a 7-item questionnaire to track psychological flexibility related to coping with cancer and cancer treatment. The scale ranges from 1 = "never true" to 7 "always true." Item is scored by adding all of the responses together. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Changes in Living in Alignment With Values: The Valuing Questionnaire (VQ) | The VQ is a 10-item self-report questionnaire with a scale 0 = "not true at all" to 6 "completely true." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Group Therapy Experiences Scale | The 17-item Group Therapy Experiences Scale will be used to assess the level of cohesion among group members (e.g., development of positive relationships, comfort level with other group members). Items 1-16 are rated on a 5-point scale with 1 = "strongly agree" to 5 = "strongly disagree." Item 17 is an open-ended question, "was there something in the group today that helped or hindered you?"relationships, comfort level with other group members). Items are rated on a 4-point scale with 1= "strongly disagree" to 4= "strongly agree." | Following completion of the intervention, up to 12 months |
| Change in Social Isolation: PROMIS Social Isolation Scale | The PROMIS Social Isolation Scale is a 6-item measure is used to assess social isolation. Participants are asked to rate each item (e.g., "I felt left out," "I feel that people avoid talking to me") on a scale from 1= "never" to 5= "always." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale | The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 "not at all confident" to 10 "totally confident." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a | The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a is a 4-item scale. Participants rate their confidence in managing their symptoms during daily activities, with relationships with friends and family, in a public place, and working with their doctor to manage these symptoms on a scale from 1 = "I am not at all confident" to 5 "I am very confident." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Change in Emotional Support: PROMIS Emotional Support-Short Form | The PROMIS Emotional Support Short Form is a 6-item measure used to assess emotional support. Participants are asked to rate each item ("I have someone who will listen to me when I need to talk," "I have someone to talk with when I have a bad day") on a scale from 1= "never" to 5= "always." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Change in Instrumental Support: PROMIS Instrumental Support-Short Form | The PROMIS Instrumental Support Short Form is a 6-item measure used to assess instrumental support. Participants are asked to rate each item (e.g., "Do you have someone to take you to the doctor if you needed it?," "Do you have someone to prepare your meals if you are unable to do it yourself?") on a scale from 1= "never" to 5= "always." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| Change in Informational Support: PROMIS Informational Support-Short Form | The PROMIS Informational Support Short Form is a 6-item measure used to assess informational support. Participants are asked to rate each item (e.g., "I have someone to turn to for suggestions about how to deal with a problem," "I have someone to give me information if I need it") on a scale from 1= "never" to 5= "always." | Baseline and again 3, 6, 9, and 12 months following the baseline assessment |
| NOT COMPLETED |
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| BG001 | Waitlist Control | Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study. |
| BG002 | Total | Total of all reporting groups |
| years |
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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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| Region of Enrollment | Count of Participants | Participants |
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| Behavioral Symptom Management for Young Adult Cancer Survivors |
The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms. |
| OG001 | Waitlist Control | Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study. |
|
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| Primary | Number of Participants Who Completed Open-Ended Questions About the Program | Intervention will be evaluated using 3 open-ended questions, including the following: "1) What was the most helpful part of the program?," "2) What was the least helpful part of the program?", and "3) What suggestions do you have for us to help improve the program?" | Participants who completed at least one intervention session. | Posted | Count of Participants | Participants | Following completion of the intervention, up to 12 months |
|
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| Primary | Percentage of Sessions Attended by Each Participant | Treatment feasibility will be assessed by measuring the session attendance rate for each participant. | Any participant who had at least one intervention session was included for analysis. | Posted | Mean | Standard Deviation | percentage of sessions | Following completion of the intervention, up to 12 months |
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| Primary | Treatment Acceptability Questionnaire | The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged. | One participant in the waitlist control condition was excluded from analysis due to an incomplete response to the measure. | Posted | Mean | Standard Deviation | score on a scale | Following completion of the intervention, up to 12 months |
|
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|
| Primary | Use of Intervention Strategies | Participants' use of intervention strategies will be assessed using a measure developed specific to components of the proposed intervention. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 "not at all" to 5 "every day" will be used. | Any participant who had at least one intervention session was included for analysis. | Posted | Mean | Standard Deviation | score on a scale | Following completion of the intervention, up to 12 months |
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| Primary | Self-reported Use of the Mobile Application | Participants' use of the mobile application will be assessed using a measure developed specific to components of the proposed mobile application. Participants will be asked about how frequently they have used components of the mobile application outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 "not at all" to 5 "2 or more times a day" will be used. | Any participant who had at least one intervention session was included for analysis. | Posted | Mean | Standard Deviation | score on a scale | Following completion of the intervention, up to 12 months |
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| Secondary | Change in Depressive Symptoms: PROMIS Depression Short Form | Depressive Symptoms will be assessed using the Patient Reported Outcomes Measurement Information System Depression Short Form-8a, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always." Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of depression. T-scores of 55 to 60 indicate mild levels of depression, 60 to 70 indicates moderate levels of depression, and greater than 70 indicate severe levels of depression. | Respondents were included if they provided a complete response to the measure. All participants received the intervention. | Posted | Mean | Standard Deviation | T-score | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
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| Secondary | Change in Anxiety: PROMIS Anxiety Short Form | Symptoms of Anxiety will be assessed using the Patient Reported Outcomes Measurement Information System Anxiety Short Form-8a, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always". Total scores are then converted to T-scores. Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of anxiety. T-scores of 55 to 60 indicate mild levels of anxiety, 60 to 70 indicates moderate levels of anxiety, and greater than 70 indicate severe levels of anxiety. | Respondents were included if they provided a complete response to the measure. All participants received the intervention. | Posted | Mean | Standard Deviation | T-score | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
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| Secondary | Change in Symptom Interference: Illness Intrusiveness Rating Scale | Symptom interference will be assessed using the Illness Intrusiveness Rating Scale (IIRS). The IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation). Items are rated on a 7-point scale from 1 "not very much" to 7 "very much." The total score ranges from 7 to 91, where a higher score indicates greater interference. | Respondents were included if they provided a complete response to the measure. All participants received the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
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| Secondary | Change in Pain: Brief Pain Inventory | The Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Participants rate their pain on a scale from 0 "no pain" to 10 "pain as bad as you can imagine." Pain severity is calculated as the average of four items assessing participants' worst, least, current, and average (in the last week) pain on a scale from 0 "no pain" to 10 "worst pain." Pain interference is computed as the average of seven items, which ask about the interference of pain across different life domains (e.g., general activity, mood, relations with other people). | Respondents were included if they provided a complete response to the measure. All participants received the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and again 3, 6, 9, and 12 months following the baseline assessment; pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
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| Secondary | Change in Fatigue: PROMIS Fatigue Short Form | Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"). Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. A higher score indicates greater fatigue. T-scores of 55 to 60 indicate mild levels of fatigue, 60 to 70 indicates moderate levels of fatigue, and greater than 70 indicate severe levels of fatigue. | All participants received the intervention. | Posted | Mean | Standard Deviation | T-score | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported |
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| Other Pre-specified | Change in Activity: International Physical Activity Questionnaire | The International Physical Activity Questionnaire is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Change in Activity: Stanford Leisure-Time Activity Categorical Item (LCAT) | The Stanford LCAT is a categorical item that assesses the type of physical activities participants do. | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT) | The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = "not at all" to 4 = "very much." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ) | The AAQ is a 7-item questionnaire to track psychological flexibility related to coping with cancer and cancer treatment. The scale ranges from 1 = "never true" to 7 "always true." Item is scored by adding all of the responses together. | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Changes in Living in Alignment With Values: The Valuing Questionnaire (VQ) | The VQ is a 10-item self-report questionnaire with a scale 0 = "not true at all" to 6 "completely true." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Group Therapy Experiences Scale | The 17-item Group Therapy Experiences Scale will be used to assess the level of cohesion among group members (e.g., development of positive relationships, comfort level with other group members). Items 1-16 are rated on a 5-point scale with 1 = "strongly agree" to 5 = "strongly disagree." Item 17 is an open-ended question, "was there something in the group today that helped or hindered you?"relationships, comfort level with other group members). Items are rated on a 4-point scale with 1= "strongly disagree" to 4= "strongly agree." | Not Posted | Aug 2025 | Following completion of the intervention, up to 12 months | Participants |
| Other Pre-specified | Change in Social Isolation: PROMIS Social Isolation Scale | The PROMIS Social Isolation Scale is a 6-item measure is used to assess social isolation. Participants are asked to rate each item (e.g., "I felt left out," "I feel that people avoid talking to me") on a scale from 1= "never" to 5= "always." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale | The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 "not at all confident" to 10 "totally confident." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a | The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a is a 4-item scale. Participants rate their confidence in managing their symptoms during daily activities, with relationships with friends and family, in a public place, and working with their doctor to manage these symptoms on a scale from 1 = "I am not at all confident" to 5 "I am very confident." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Change in Emotional Support: PROMIS Emotional Support-Short Form | The PROMIS Emotional Support Short Form is a 6-item measure used to assess emotional support. Participants are asked to rate each item ("I have someone who will listen to me when I need to talk," "I have someone to talk with when I have a bad day") on a scale from 1= "never" to 5= "always." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Change in Instrumental Support: PROMIS Instrumental Support-Short Form | The PROMIS Instrumental Support Short Form is a 6-item measure used to assess instrumental support. Participants are asked to rate each item (e.g., "Do you have someone to take you to the doctor if you needed it?," "Do you have someone to prepare your meals if you are unable to do it yourself?") on a scale from 1= "never" to 5= "always." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| Other Pre-specified | Change in Informational Support: PROMIS Informational Support-Short Form | The PROMIS Informational Support Short Form is a 6-item measure used to assess informational support. Participants are asked to rate each item (e.g., "I have someone to turn to for suggestions about how to deal with a problem," "I have someone to give me information if I need it") on a scale from 1= "never" to 5= "always." | Not Posted | Aug 2025 | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Waitlist Control - Intervention | Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Waitlist Control - No Intervention | Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D004700 | Endocrine System Diseases |
| Pain Interference |
|
|
Effect size (Hedges' g) of 0.18
| 0.2084 |
| Mean Difference (Net) |
| 0.5 |
| Standard Deviation |
| 2.6 |
| Superiority |