Symptom Management for YA Cancer Survivors

Improving Symptom Management for Survivors of Young Adult Cancer

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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Pain; Cancer; Breast Cancer; Fatigue; Psychological Distress; Germ Cell Tumor; Young Adult; Hematologic Cancer; Endocrine Cancer
• Intervention / Treatment: Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors; 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.
Active Comparator: 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.	Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	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.	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

Other 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
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
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
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Caroline S Dorfman, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Young Adult; Behavioral Symptom Management
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hematologic Neoplasms; Neoplasms, Germ Cell and Embryonal; Endocrine Gland Neoplasms
• Other Study ID Numbers: Pro00103249; 1K08CA245107-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No