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Digital Health Coaching for Cancer Survivorship (COACH Trial)

N/A

Recruiting

Led By Rachael Schmidt, DNP

Research Sponsored by Pack Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have primary diagnosis of cancer;

Are aged 18 years and older;

Must not have

Are on active treatment for relapsed disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a digital health coaching intervention for people who have completed primary cancer therapy, to see if it's effective, acceptable, and feasible. 500 people with different types of cancer will be enrolled at up to 5 clinical sites.

Who is the study for?

This trial is for cancer survivors who've finished their primary therapy within the last year. Participants must be adults (18+), able to read and speak English, consent to join, follow the study schedule, use a smartphone or tablet, and wear a Fitbit. Excluded are those with cognitive impairments, less than 6 months life expectancy, conditions limiting physical activity, or active treatment for relapsed disease.

What is being tested?

The study tests a digital health coaching program alongside Fitbit monitoring in cancer survivors post-treatment. It's set up so half of the participants start with coaching right away and then switch to just monitoring after 6 months; the other half do it in reverse order. They'll also give fecal samples to check gut health changes.

What are the potential side effects?

Since this isn't testing drugs but rather lifestyle interventions through digital coaching and fitness tracking, typical medication side effects aren't expected. However, some may experience discomfort or privacy concerns related to wearing a Fitbit or stress from lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cancer.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving treatment for my cancer that has come back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of coaching intervention

Change in Self-Efficacy for Managing Chronic Disease

Feasibility of coaching intervention

Secondary study objectives

Change in Anxiety as measured by the PROMIS Anxiety Short Form 8a

Change in Cognitive Function as measured by the PROMIS Cognitive Function Short Form 8a

Change in Depression as measured by the PROMIS Depression Short Form 8a

+8 more

Other study objectives

Change in medication adherence for individuals taking maintenance therapies

Dietary Intake as measured by the Diet History Questionnaire (DHQ) III

Digital Engagement

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Wait List Control GroupExperimental Treatment2 Interventions

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.

Group II: Intervention GroupExperimental Treatment2 Interventions

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.

Group III: Household Healthy ParticipantsActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fitbit

2021

N/A

~3560

0 / 3Eligibility criteria met