Comprehensive Outcomes for After Cancer Health (COACH)
Categories (click each to see list of all clinical trials associated with that category): ONC CTO Non-Traditional (ONCCTO)
Current Status: Open
Phase: N/A (Cancer Prevention)
Principal Investigator: Schmidt, Rachael
Eligibility: https://clinicaltrials.gov/study/NCT05349227?term=NCT05349227&rank=1
Summary
The purpose of this randomized, wait-list control study is to explore the feasibility, acceptability, and effect of a 6-month digital health coaching program among cancer survivors within a year of primary treatment, and to understand the experiences of individuals following completion of primary treatment.
We further seek to explore associations between participants engagement in this digital health coaching program and patient-reported, wearable, biomarker, and clinical outcomes among cancer survivors. This study offers a unique opportunity to characterize and more deeply understand cancer survivors unique needs, experiences, and concerns following completion of primary therapy, while developing a new understanding of how digital health coaching may bridge the gap between clinical and community settings.
1.1 Primary Aims
1.1.1 Evaluate the feasibility and acceptability (of a 6-month digital health coaching program in cancer survivors within the first year following completion of primary cancer therapy. For this study, feasibility is defined as ≥50% approach-to-enrollment rate of eligible participants and ≥70% completion of 6-month outcome assessments. Acceptability is defined as ≤20% of participants reporting high study burden and ≤20% withdrawing from the study.
1.1.2 Evaluate the effect of digital health coaching on health self-efficacy, defined as an individual s confidence in managing his/her/their health condition and associated problems.1,2 Effect of the digital health coaching will be measured by an improvement in health self-efficacy, as measured by Self-Efficacy for Managing Chronic Disease Questionnaire.