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Comprehensive Outcomes for After Cancer Health
NCT05349227 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DEVICE Fitbit
- BEHAVIORAL Digital Health Coaching Program
Study Locations (7)
Texas
- The University of Texas MD Anderson Cancer Center — Houston
- UT Health Houston — Houston
Florida
- The University of Florida — Gainesville
Massachusetts
- Dana Farber Cancer Institute — Boston
Nebraska
- University of Nebraska Medical Center — Omaha
New York
- Memorial Sloan Kettering Cancer Center — New York
Ohio
- The Ohio State University Wexner Medical Center — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 625 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2027-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05349227
The ClinicalTrials.gov registry entry for NCT05349227 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 625 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pack Health, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Fitbit is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05349227 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Texas, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05349227 about?
NCT05349227 is a clinical study titled "Comprehensive Outcomes for After Cancer Health". 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 par...
What is the current status of trial NCT05349227?
This trial is currently recruiting. It is a NA study. The enrollment target is 625 participants. The study started on 2022-06-23. Estimated completion is 2027-05.
What conditions does trial NCT05349227 study?
This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Ovarian Cancer, Endometrial Cancer, Gastric Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05349227?
The interventions under investigation include: Fitbit (DEVICE), Digital Health Coaching Program (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05349227?
This trial is sponsored by Pack Health, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05349227 being conducted?
This trial has 7 study locations across Florida, Massachusetts, Nebraska, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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