Recruiting

Comprehensive Outcomes for After Cancer Health

ClinicalTrials.gov IDNCT05349227

PhaseNA

Enrollment625

SponsorPack Health

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

Behavioral: 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.
Device: 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.

Primary outcomes

Acceptability of coaching intervention (At 6 months following the start of the coaching intervention)
Feasibility of coaching intervention (At 6 months following the start of the coaching intervention)
Change in Self-Efficacy for Managing Chronic Disease (Change in baseline perception of self-efficacy at 12 months)

Eligibility information

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;

Study locations

The University of Florida, Gainesville, Florida 32610 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02215 United States
University of Nebraska Medical Center, Omaha, Nebraska 68106 United States
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
The Ohio State University Wexner Medical Center, Columbus, Ohio 43210 United States
The University of Texas MD Anderson Cancer Center, Houston, Texas 77030 United States
UT Health Houston, Houston, Texas 77030 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.