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RECRUITING
NCT05349227
NA

Comprehensive Outcomes for After Cancer Health

Sponsor: Pack Health

View on ClinicalTrials.gov

Summary

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 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 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.

Official title: Comprehensive Outcomes for After Cancer Health (COACH): the Feasibility and Impact of an MHealth Augmented Coaching Program for Self-Management in Cancer Survivors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

625

Start Date

2022-06-23

Completion Date

2027-05

Last Updated

2024-12-11

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Digital Health Coaching Program

Coaching consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

DEVICE

Fitbit

Device: Fitbit A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Locations (7)

The University of Florida

Gainesville, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

UT Health Houston

Houston, Texas, United States