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

doi:10.1016/j.cct.2024.107545

A digital, coach-assisted intervention to address the psychosocial needs of young adult cancer survivors: Randomized controlled trial protocol and intervention adaptation process

Contemp Clin Trials. 2024 Apr 23:141:107545. doi: 10.1016/j.cct.2024.107545. Online ahead of print.

Authors

Darcey M McCready¹, Hannah Arem², Danielle A Duarte¹, Kyla Dennis¹, Nathan Ball¹, Lauren A Cafferty¹, Pamela S Hinds³, Afrah Howlader⁴, Carla J Berg⁵

Affiliations

¹ Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, USA.
² Healthcare Delivery Research, MedStar Health Research Institute, USA; Department of Oncology, Georgetown University, USA.
³ Department of Pediatrics, George Washington University, Children's National Hospital, USA; GW Cancer Center, George Washington University, USA.
⁴ Department of Health Policy and Management, Milken Institute School of Public Health, George Washington University, USA.
⁵ Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, USA; GW Cancer Center, George Washington University, USA. Electronic address: carlaberg@gwu.edu.

PMID: 38657732
DOI: 10.1016/j.cct.2024.107545

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.

Trial registration: NCT05905250.

Keywords: Acceptance and commitment therapy; Cancer survivorship; Health promotion; Hope; Positive psychology; Quality of life; Young adult cancer survivors.

Associated data

ClinicalTrials.gov/NCT05905250

Grants and funding

R21 CA261884/CA/NCI NIH HHS/United States