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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
65
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.
Duke Cancer Institute
Durham, North Carolina, United States
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.
Time frame: 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?"
Time frame: 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.
Time frame: 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.
Time frame: Following completion of the intervention, up to 12 months
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.
Time frame: 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.
Time frame: Following completion of the intervention, up to 12 months
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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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).
Time frame: 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.
Time frame: 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