A digital, coach-assisted intervention to address the psychosocial needs of young adult cancer survivors: Randomized controlled trial protocol and intervention adaptation process
Darcey M. McCready , Hannah Arem , Danielle A. Duarte , Kyla Dennis , Nathan Ball , Lauren A. Cafferty , Pamela S. Hinds , Afrah Howlader , Carla J. Berg
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引用次数: 0
Abstract
Background
Given the increasing number of young adult cancer survivors and the impacts of cancer on various life domains, interventions addressing the psychosocial needs of young adult survivors are crucial. However, such intervention research is limited, and the existing literature has often: 1) overlooked young adult survivors' psychosocial needs; 2) targeted depression, anxiety, or fear of recurrence – rather than positive outcomes like well-being; and 3) failed to consider scalable approaches, like digital health.
Methods
This paper documents the development and refinement of an 8-week digital, coach-assisted intervention targeting hope among young adult cancer survivors (ages 18–39, within 3 years of treatment completion) and presents the protocol of the 2-arm RCT (comparing intervention vs. attention control). The intervention builds upon a 2017–2018 pilot trial (n = 56); intervention refinements were based on subsequent semi-structured interviews among young adult survivors (n = 23).
Results
The pending trial design involves an increased sample size (n = 150) to increase power and diversified recruitment efforts (i.e., clinic-based, social media, community-based organizations, etc.) to facilitate intervention reach, accessibility, and scalability. The intervention was enhanced by integrating highly relevant theoretical and therapeutic frameworks, specifically the concept of hope and Acceptance and Commitment Therapy, as well as updating intervention delivery technology. Intervention outcomes include feasibility and acceptability at end-of-treatment and preliminary efficacy on hope (primary outcome) and quality of life measures (secondary outcomes) at end-of-treatment and 16-week follow-up.
Conclusions
This paper may facilitate discussion regarding approaches for addressing the significant psychosocial challenges faced by young adult survivors and catalyze dissemination of trial results.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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