Digital health coaching for cancer survivors
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 is testing whether a digital health coaching program can help cancer survivors feel better and improve their health after finishing treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 625 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pack Health Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 7 sites (Gainesville, Florida and 6 other locations) |
| Trial ID | NCT05349227 on ClinicalTrials.gov |
What this trial studies
This study explores the feasibility and outcomes of a digital health coaching intervention for individuals who have completed primary cancer therapy. Up to 625 participants with various cancer diagnoses will be enrolled across multiple clinical sites in a randomized wait-list control design. Participants in the intervention group will receive six months of digital coaching, while the control group will receive monitoring for six months before starting the coaching. The study aims to assess the impact of digital health coaching on patient-reported outcomes, clinical outcomes, and microbiome data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have completed primary cancer therapy within the last year or have a diagnosis of metastatic cancer.
Not a fit: Patients who are not within one year of completing primary therapy or who cannot read and consent to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve the quality of life and health outcomes for cancer survivors.
How similar studies have performed: Other studies have shown promise in using digital health interventions for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 1. 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 2. For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment). 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. 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;
Where this trial is running
Gainesville, Florida and 6 other locations
- The University of Florida — Gainesville, Florida, United States (Active_not_recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Active_not_recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Not_yet_recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Active_not_recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
- UT Health Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Marilyn Hammer, PhD — Dana-Farber Cancer Institute
- Study coordinator: Kelly J Brassil, PhD
- Email: dgxpharesearch@questdiagnostics.com
- Phone: 205-721-7542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.