Symptom management and transitioning to engagement with post-treatment care for adolescent and young adult cancer survivors (AYA STEPS): Study protocol.
This paper reports the protocol for a 260-participant Phase II randomized trial comparing a six-session remotely delivered behavioral intervention with an education-only attention control to improve symptom burden, self-management, patient activation, and follow-up healthcare engagement among AYA cancer survivors.
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This paper reports the protocol for a 260-participant Phase II randomized trial comparing a six-session remotely delivered behavioral intervention with an education-only attention control to improve symptom burden, self-management, patient activation, and follow-up healthcare engagement among AYA cancer survivors.
Research significance
The protocol proposes—but does not yet demonstrate—that cognitive-behavioral and patient-activation strategies delivered through AYA STEPS will increase self-efficacy and patient activation, thereby reducing post-treatment symptom burden and improving engagement with survivorship care.
Source abstract
For adolescent and young adult (AYA) cancer survivors, treatment impacts are significant and long-lasting, including physical symptoms (e.g., pain, fatigue), emotional distress (e.g., anxiety, depression), and increased risk for long-term health problems (e.g., second cancers, early-onset cardiovascular disease). After cancer therapy, many AYAs lose contact with their oncology team and fail to establish care with providers knowledgeable of their risks and continued care needs. Consequently, AYAs experience inadequate surveillance for late effects and missed opportunities for symptom management and psychological support. We developed an accessible six-session digital health intervention, AYA STEPS (Symptom Management and Transitioning to Engagement with Post-Treatment Care for AYA Survivors) to enhance AYA survivors' management of high symptom burden and engagement in follow-up healthcare. The remotely delivered behavioral intervention targets patient activation and self-efficacy through cognitive-behavioral and patient activation theory-based approaches. This paper outlines the protocol for a Phase II randomized controlled trial to examine AYA STEPS' efficacy compared to a six-session education-only time and attention control comparison condition among N = 260 AYAs. AYAs aged 18-39 who were treated for breast, colorectal, or testicular cancer, sarcoma, or lymphoma one to five years ago are randomized 1:1 to the AYA STEPS or education arms. The project aims to determine whether AYA STEPS reduces symptom burden, improves healthcare engagement, and increases symptom management self-efficacy and patient activation, and whether self-efficacy and patient activation mediate AYA STEPS' impact on symptom burden and care engagement. If efficacious, AYA STEPS could yield meaningful public health impact by addressing significant unmet needs among AYAs. TRIALS REGISTRATION: ClinicalTrials.gov, NCT06371768, registered 04/11/2024.