RecruitingNot ApplicableNCT05349227

Comprehensive Outcomes for After Cancer Health

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

Sponsor

Pack Health

Enrollment

625 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic Breast Cancer Gastric Cancer Ovarian Cancer Endometrial Cancer Lung Cancer Metastatic Cancer Survivorship Prostate Cancers Head and Neck Cancers Geriatric Oncology

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the overall health and quality of life of cancer survivors after they finish their main treatment. It uses a digital health coaching program and wearable devices to track physical activity, wellbeing, and patient-reported outcomes over time. **You may be eligible if...** - You are 18 or older and have been diagnosed with any type of cancer - You completed your main cancer treatment within the last year, OR you have metastatic cancer and are within one year of finishing initial or ongoing treatment - You can read and speak English - You have access to a smartphone or tablet **You may NOT be eligible if...** - You have a cognitive impairment that would prevent you from engaging with the digital coaching program - You have a condition (neurological, musculoskeletal, or other) that prevents you from doing physical activity - You have a life expectancy of less than 6 months - You are currently receiving treatment for a relapse of your cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDigital 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.

DEVICEFitbit

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.