Symptom Management for YA Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Symptom Management for Survivors of Young Adult Cancer

Conditions
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Cancer, Young Adult, Pain, Psychological Distress, Fatigue, Breast Cancer, Melanoma, Hematologic Cancer, Germ Cell Tumor, Endocrine Cancer

Intervention / Treatment
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* Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors


Participation Criteria
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Eligibility Criteria
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Young Adult Cancer Survivors Participating in Intervention Development Interviews Eligibility Criteria Diagnosed with hematologic, breast, gastrointestinal, or endocrine cancers, melanoma, or germ cell tumors Diagnosed with cancer as a young adult Under the care of a medical provider at the Duke Cancer Institute Completed curative treatment involving multimodal therapy within the last five years Able to speak and read English Able to give informed consent Exclusion Criteria Nonambulatory Major mental illness, i.e., schizophrenia Untreated or uncontrolled mental illness, i.e., bipolar Residence greater than 100 miles from the research site 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 Diagnosed with hematologic, breast, gastrointestinal cancers, or endocrine cancers, melanoma, or germ cell tumors Diagnosed with cancer as a young adult Under the care of a medical provider at the Duke Cancer Institute Completed curative treatment involving multimodal therapy within the last five years Able to speak and read English Able to give informed consent Exclusion Criteria Nonambulatory Major mental illness, i.e., schizophrenia Untreated or uncontrolled mental illness, i.e., bipolar Residence great than 100 miles from the research site RCT Participants Eligibility Criteria: diagnosed with cancer as a YA (aged 18-39) diagnosis of hematologic, breast, endocrine or gastrointestinal cancer, melanoma, or germ cell tumor receiving care at the Duke Cancer Institute completed curative treatment involving multimodal therapy within the last 2 years able to speak/read English; and able to give informed consent. Exclusion Criteria: non-ambulatory major mental illness (i.e., schizophrenia) untreated or uncontrolled mental illness (i.e., bipolar disorder)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A two-arm, cluster RCT employing a wait-list control arm will be used. Six cohorts of YA survivors (n=10/cohort) will be randomized with equal allocation to the intervention or control arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Symptom Management for Young Adult Cancer Survivors<br>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. | Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors<br>* 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.<br>|
| Active Comparator: Waitlist Control<br>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. | Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Satistfaction: SSTS-R | Intervention satisfaction will be assessed using the SSTS-R, a 13-item measure with the first 12-items on a five-point scale ranging from 1 strongly disagree to 5 strongly disagree. The 13th item asks, How much did the intervention help with your sypmtoms? with 5 answer choices ranging from made things a lot better to made things a lot worse. | Following completion of the intervention, up to 12 months | 
| 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 | 
| Session attendance | 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). | Following completion of the intervention, up to 12 months | 
| Change in Depressive Symptoms: PROMIS Depression Short Form | Depressive Symptoms will be assessed using the PROMIS Depression Short Form, 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. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | 
| Change in Anxiety: PROMIS Anxiety Short Form | Symptoms of Anxiety will be assessed using the PROMIS Anxiety Short Form, 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. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | 
| 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. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | 
| 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 2 or more times a 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 | 
| 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. | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | 
| Change in Fatigue: PROMIS Fatigue Short Form | Fatigue will be assessed using the PROMIS 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?). Respon | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Young Adult, Behavioral Symptom Management