Condition(s):Breast Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Survivorship
Phase:Feasibility / Pilot
Principal Investigator:Hammer, Marilyn, J
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.
- 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
- 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
- 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
- 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