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Comprehensive Outcomes for After Cancer Health (COACH): The Feasibility and Impact of an mHealth Augmented Coaching Program for Self-Management in Cancer Survivors


Trial ID:NCT05349227

View complete trial on

Protocol #:21-737

877-DF-TRIAL (877-338-7425)

Condition(s):Breast Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Survivorship

Phase:Feasibility / Pilot

Principal Investigator:Hammer, Marilyn, J

Trial Description:
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 500 individuals with diverse cancer diagnoses will be enrolled across up to 5 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.

Eligibility Requirements:
- Have primary diagnosis of cancer;
- Are within 1 year of completion of primary therapy; For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy
- Are aged 18 years and older;
- Can read and consent to participate in the trial;
- Can read and speak English;
- Can complete study follow-up at pre-specified intervals;
- Have access to mobile technology (e.g. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.
- Agree to wear and have data collected from an activity tracking device
Exclusion Criteria:
- Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;
- Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
- Have a life expectancy of <6 months, and/or
- Are on active treatment for relapsed disease.

Protocol #: 21-737

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