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Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Metastatic Breast Cancer Clinical Trial

Official title:
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02682836
Study type Interventional
Source UNC Lineberger Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date October 2015
Completion date December 1, 2019
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