Symptom Management for YA Cancer Survivors

Not Applicable

Completed

• Conditions: Endocrine Cancer; Young Adult; Pain; Psychological Distress; Hematologic Cancer; Cancer; Fatigue; Breast Cancer; Melanoma; Germ Cell Tumor
• Interventions: Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors

• Registration Number: NCT04035447
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2020-01-22
• Status Verified: 2024-06
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

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Exclusion Criteria

• non-ambulatory
• major mental illness (i.e., schizophrenia)
• untreated or uncontrolled mental illness (i.e., bipolar disorder)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Waitlist Control	Behavioral Symptom Management for Young Adult Cancer Survivors	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 Symptom Management for Young Adult Cancer Survivors	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.

Primary Outcome Measures

Name	Time	Method
Session attendance	Following completion of the intervention, up to 12 months	Treatment feasibility will be assessed by measuring the session attendance rate for each participant.
Intervention Satistfaction: SSTS-R	Following completion of the intervention, up to 12 months	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."
Open-Ended Questions About the Program	Following completion of the intervention, up to 12 months	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?"
Treatment Acceptability Questionnaire	Following completion of the intervention, up to 12 months	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).
Change in Depressive Symptoms: PROMIS Depression Short Form	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."
Change in Anxiety: PROMIS Anxiety Short Form	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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".
Use of Intervention Strategies	Following completion of the intervention, up to 12 months	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.
Self-reported use of the Mobile Application	Following completion of the intervention, up to 12 months	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.
Change in Pain: Brief Pain Inventory	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."
Change in Fatigue: PROMIS Fatigue Short Form	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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
Change in Symptom Interference: Illness intrusiveness rating scale	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."

Secondary Outcome Measures

Name	Time	Method
Group Therapy Experiences Scale	Following completion of the intervention, up to 12 months	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."
Change in Social Isolation: PROMIS Social Isolation Scale	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."
Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."
Change in Emotional Support: PROMIS Emotional Support-Short Form	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."
Change in Instrumental Support: PROMIS Instrumental Support-Short Form	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."
Change in Informational Support: PROMIS Informational Support-Short Form	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."
Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a	Baseline and again 3, 6, 9, and 12 months following the baseline assessment	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."

Trial Locations

Locations (1)

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States