Abstract
Purpose: This study aimed to (1) develop TOGETHER-YA, an e-Health-delivered and group-based health-related quality of life (HRQOL) intervention for young adult (YA) cancer survivors aged 18–39 (Part 1), and (2) determine its initial feasibility and acceptability in a single-arm pilot trial (Part 2). Methods: TOGETHER-YA is a manualized, 10-week intervention for YA survivors that includes elements of relaxation training, cognitive-behavioral therapy, and health education. In Part 1, content was adapted from existing evidence-based interventions with feedback from YAs (N = 22) in four iterative focus groups. In Part 2, YA survivors (N = 11) participated in a single-arm pilot trial of TOGETHER-YA. Intervention groups were led by a trained facilitator over videoconference. Primary outcomes were feasibility (i.e., recruitment, session attendance, retention) and acceptability (i.e., participant satisfaction). Results: Focus groups reacted positively to TOGETHER-YA and provided actionable recommendations for enhancing its relevance and acceptability, which were implemented. In initial testing, all feasibility and acceptability benchmarks were met; 58% of eligible YAs were recruited, participants attended M = 6 intervention sessions (SD = 3), and 82% of participants were retained post-intervention. On average, participants “agreed” to “strongly agreed” with positive statements about the weekly sessions and the overall program. Conclusion: TOGETHER-YA was developed in collaboration with YA cancer survivors and found to be feasible and acceptable in initial testing. TOGETHER-YA is the first HRQOL intervention for a broad range of YA survivors that is eHealth-delivered for convenience and group-based for peer support. Future large-scale trials should test its efficacy for improving HRQOL. Trial registration: NCT05048316, September 17, 2021; NCT05054569, September 23, 2021.
Original language | English (US) |
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Pages (from-to) | 10067-10076 |
Number of pages | 10 |
Journal | Supportive Care in Cancer |
Volume | 30 |
Issue number | 12 |
DOIs | |
State | Published - Dec 2022 |
Funding
This study was supported in part by Institutional Research Grants from the American Cancer Society (IRG-174–173-22, PI: Oswald) (IRG-18–163-24, PI: Fox), the National Cancer Institute of the National Institutes of Health (R01-CA242849, PI: Salsman) (K08-CA247973, PI: Fox) (P30-CA076292), and the National Center for Advancing Translational Sciences of the National Institutes of Health (UL1-TR001422). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Jim is a consultant for RedHill BioPharma, Janssen Scientific Affairs, and Merck and has grant funding from Kite Pharma. Dr. Gonzalez is a consultant for SureMed Compliance and KemPharm, and an advisory board member for Elly Health, Inc. Dr. Antoni is a consultant for Blue Note Therapeutics and Atlantis Healthcare. Dr. Penedo is a consultant for Blue Note Therapeutics. Dr. Reed is a consultant for Springworks and Eisai. All other authors have no relevant financial or non-financial interests to disclose. Dr. Jim is a consultant for RedHill BioPharma, Janssen Scientific Affairs, and Merck and has grant funding from Kite Pharma. Dr. Gonzalez is a consultant for SureMed Compliance and KemPharm, and an advisory board member for Elly Health, Inc. Dr. Antoni is a consultant for Blue Note Therapeutics and Atlantis Healthcare. Dr. Penedo is a consultant for Blue Note Therapeutics. Dr. Reed is a consultant for SpringWorks and Eisai. All other authors have no relevant financial or non-financial interests to disclose.
Keywords
- Cancer survivors
- Clinical trials, non-randomized
- Psychosocial intervention
- Qualitative research
- Young adult
ASJC Scopus subject areas
- Oncology