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

NCT02682836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-06

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Walk with Ease

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Kirsten A Nyrop, PhD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-10-31
Completion
2019-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02682836 on ClinicalTrials.gov