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NCT02682836 · ClinicalTrials.gov registry record · NA
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
A NA study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT02682836 is a NA study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 60 participants.
The verdict
NCT02682836, a NA study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.
Interventions
- BEHAVIORAL Walk with Ease
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-10 |
| Est. Completion | 2019-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02682836
The ClinicalTrials.gov registry entry for NCT02682836 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Walk with Ease is the first listed.
NCT02682836 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02682836 about?
NCT02682836 is a clinical study titled "Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study". Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early...
What is the current status of trial NCT02682836?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2015-10. Estimated completion is 2019-12-01.
What interventions are being tested in trial NCT02682836?
The interventions under investigation include: Walk with Ease (BEHAVIORAL).
Who is sponsoring clinical trial NCT02682836?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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