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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Have primary diagnosis of cancer;

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

‣ 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

⁃ 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).

• 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.

Locations
United States
Florida
The University of Florida
ACTIVE_NOT_RECRUITING
Gainesville
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Nebraska
University of Nebraska Medical Center
ACTIVE_NOT_RECRUITING
Omaha
New York
Memorial Sloan Kettering Cancer Center
NOT_YET_RECRUITING
New York
Ohio
The Ohio State University Wexner Medical Center
ACTIVE_NOT_RECRUITING
Columbus
Texas
The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
UT Health Houston
RECRUITING
Houston
Contact Information
Primary
Kelly J Brassil, PhD
dgxpharesearch@questdiagnostics.com
205-721-7542
Backup
Jennifer Loftis, DNP
dgxpharesearch@questdiagnostics.com
205-721-7542
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2027-05
Participants
Target number of participants: 625
Treatments
Experimental: Intervention Group
In addition to standard of care services at the participant's respective health system, and study specific collection of clinical, PRO, and wearable data, as well as microbiome specimens, individuals randomized to the intervention group will receive immediate enrollment to a 6-month digital health coaching program followed by 6 months monitoring via PRO, wearable, and clinical data collection. They will collect fecal microbiome samples at baseline (study enrollment) and month 6 following enrollment.
Other: Wait List Control Group
In addition to standard of care services, individuals in the wait list control will be monitored via the collection of PRO, clinical, and wearable data for the first 6 months, along with fecal microbiome collection at study enrollment baseline (study enrollment) and month 6. At month 6 these individuals will be enrolled into the 6-month digital health coaching program, during which clinical, PRO and wearable data will continue to be collected. At the completion of the 6-month coaching these individuals will come off study and will not receive additional follow-up.
No_intervention: Household Healthy Participants
A cohort of consisting of adults without a cancer diagnosis residing in the same residence as participants, will be consented to collect fecal microbiome specimens to serve as a control for potential regional variation in microbiome dysbiosis. Up to 25 healthy controls will be enrolled per 100 participants at each study site. At sites enrolling fewer than 100 participants, an n up to 25% of the total patient enrollment sample will be approached for enrollment.
Authors
Jessica L Krok-Schoen, Alexi Wright
Sponsors
Collaborators: The University of Texas Health Science Center, Houston, National Institute of Nursing Research (NINR), Memorial Sloan Kettering Cancer Center, University of Nebraska, University of Florida, Dana-Farber Cancer Institute, Daiichi Sankyo, Gilead Sciences, Ohio State University Comprehensive Cancer Center, GlaxoSmithKline, M.D. Anderson Cancer Center
Leads: Pack Health

This content was sourced from clinicaltrials.gov