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

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.

Inclusion Criteria:

1. Have primary diagnosis of cancer;

2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic
cancer

a. 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

3. Are aged 18 years and older;

4. Can read and consent to participate in the trial;

5. Can read and speak English;

6. Can complete study follow-up at pre-specified intervals;

7. 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.

8. Agree to wear and have data collected from an activity tracking device

Exclusion Criteria:

1. 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;

2. Have a neurologic, musculoskeletal, or other comorbid condition that would impede
their ability to engage in physical activity (as assessed by their provider)

3. Have a life expectancy of <6 months, and/or

4. Are on active treatment for relapsed disease. a. Individuals with disease progression
or relapse which occurs following their consent to participate will be given the
option to continue on study if they wish to do so. Data from individuals experiencing
disease progression or relapse will be grouped for sub-analysis to explore if and how
relapse impacts study outcomes.

Healthy Volunteers must:

1. Be adults aged 18 years or older or the age of majority in their state of residence,
whichever is older.

2. Must reside in the same dwelling as the patient participant

3. Can read and consent to participate in the trial;

4. Can read and speak English;

5. Can complete study follow-up at pre-specified intervals;