Comprehensive Outcomes for After Cancer Health

NCT05349227 · tracked via the Priya Life Science USA tracker

Sponsor

Pack Health

Phase

Not applicable

Started

2022-06-23

Last updated

2024-12-11

Condition(s) studied

Ovarian CancerBreast CancerLung CancerGastric CancerSurvivorshipEndometrial CancerHead and Neck CancersProstate CancersGeriatric OncologyMetastatic Breast CancerMetastatic Cancer

Investigational drug(s) / intervention(s)

Digital Health Coaching ProgramFitbit

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.

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: 1. Have primary diagnosis of cancer; 2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer 1. 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 2. 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). 3. Are aged 18 years and older; 4. Can read and consent to participate in the trial; 5. Can read and speak English; 6. Can complete study follow-up at pre-specified intervals; 7. 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. Exclusion Criteria: 1. Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments; 2. Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider) 3. Have a life expectancy of \<6 months, and/or 4. Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes. Healthy Volunteers must: 1. Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older. 2. Must reside in the same dwelling as the patient participant 3. Can read and consent to participate in the trial; 4. Can read and speak English; 5. Can complete study follow-up at pre-specified intervals;

Primary outcome measure(s)

Acceptability of coaching intervention — At 6 months following the start of the coaching intervention
A 3-item questionnaire evaluating the following: 1) The digital health coaching program is easy to participate in; 2) the digital health coaching program is useful to me; 3) the digital health coaching program is relevant to my survivorship experience. Responses will be provided on a 10-point Likert scale ranging from 1 (Not at all) to 10 (Very Much).
Feasibility of coaching intervention — At 6 months following the start of the coaching intervention
A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching program completing the 6-months of engagement post-enrollment.
Change in Self-Efficacy for Managing Chronic Disease — Change in baseline perception of self-efficacy at 12 months
A 6-item instrument measures how confident an individual is in engaging in certain health management activities. Responses are provided on a 10-point scale ranging from 1(not at all confident) to 10 (totally confident). A mean score is calculated for the instrument with a higher score indicating higher self-efficacy.

Trial sites (7)

Facility	City	Region	Status
The University of Florida	Gainesville	Florida	Active Not Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	Active Not Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Not Yet Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	Active Not Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	Not Yet Recruiting
UT Health Houston	Houston	Texas	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05349227 on ClinicalTrials.gov ↗ ← All trials in the USA