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Digital Health Coaching for Cancer Survivorship (COACH Trial)

N/A

Recruiting

Led By Meagan Whisenant, PhD

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;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment to 12 months

Awards & highlights

COACH Trial 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.Check my eligibility

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.See study design

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.

COACH Trial 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.

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I am 18 years old or older.

COACH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of coaching intervention

Change in Self-Efficacy for Managing Chronic Disease

Feasibility of coaching intervention

Secondary outcome measures

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 outcome measures

Change in medication adherence for individuals taking maintenance therapies

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

Digital Engagement

+3 more

COACH 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonOTHER

904 Previous Clinical Trials

320,300 Total Patients Enrolled

Daiichi SankyoIndustry Sponsor

392 Previous Clinical Trials

415,566 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,974 Previous Clinical Trials

1,788,736 Total Patients Enrolled

Media Library

Digital Health Coaching Program Clinical Trial Eligibility Overview. Trial Name: NCT05349227 — N/A

Survivorship Research Study Groups: Wait List Control Group, Household Healthy Participants, Intervention Group

Survivorship Clinical Trial 2023: Digital Health Coaching Program Highlights & Side Effects. Trial Name: NCT05349227 — N/A

Digital Health Coaching Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05349227 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to new participants?

"The trial, which was initially made available on June 23rd 2022 and recently updated November 15th 2022, is actively recruiting participants. This has been reported in the clinicaltrials.gov listing for the study."

Answered by AI

What is the objective of this clinical experiment?

"The principal goal of this medical trial, which is assessed after 6 months following the start of the coaching intervention, is to identify its acceptability. Secondary objectives include measuring changes in quality-of-life via The Functional Assessment of Cancer Therapy - General v4 (FACT-G), Comprehensive Score for Financial Toxicity (COST) and Cognitive Function as measured by PROMIS Cognitive Function Short Form 8a; each instrument utilizes a five point Likert scale ranging from 0 to 4."

Answered by AI

What is the aggregate number of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov's records illustrate that this investigation is recruiting test subjects, which was first advertised on June 23rd 2022 and last updated November 15th 2022. The research requires 500 volunteers to be recruited from 3 distinct medical centres."

Answered by AI