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NCT05349227 · ClinicalTrials.gov registry record · NA
Comprehensive Outcomes for After Cancer Health
A NA study of Breast Cancer and Lung Cancer, sponsored by Pack Health.
- Recruiting
- Registry status
- NA
- Development phase
- 625
- Enrollment target
- 7
- Study locations
NCT05349227: Recruiting NA study of Breast Cancer and Lung Cancer, sponsored by Pack Health.
NCT05349227 is a NA study of Breast Cancer and Lung Cancer that is actively recruiting participants, run by Pack Health. The registered enrollment target is 625 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05349227, a NA study of Breast Cancer and Lung Cancer, is actively recruiting participants, sponsored by Pack Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 625 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
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).
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 |
What NCT05349227 shows while recruiting
NCT05349227 is an interventional study that assigns participants to a tested intervention. The registered 625 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (78% lower).
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.
NCT05349227 lists 7 locations in 6 states (Texas, Florida, Massachusetts).
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.
What interventions are being tested in trial NCT05349227?
The interventions under investigation include: Fitbit (DEVICE), Digital Health Coaching Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05349227?
This trial is sponsored by Pack Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05349227's enrollment target sits among peer trials
625 171st of 1224 higher than 1,053 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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