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

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Behavioral: Walk with Ease

• Registration Number: NCT02682836
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Primary Completion: 2019-10
• Study Completion: 2019-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Female
• Age 21 or older
• Metastatic breast cancer (MBC) diagnosis - Stage IV
• Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens
• Approval from the treating clinician to engage in moderate-intensity physical activity.
• Patient-assessed ability to walk and engage in moderate physical activity
• Proficient in English.
• IRB approved signed written informed consent.
• Willing and able to do all study requirements.

Exclusion Criteria

• One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention.
• No more than 3 prior chemotherapy regimens.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Walk with Ease	Walk with Ease physical activity intervention

Primary Outcome Measures

Name	Time	Method
changes in fatigue scores	at 3 months	Evaluate change in PROMIS Fatigue scores from baseline to 3 months

Trial Locations

Locations (1)

UNC Cancer Hospital; 🇺🇸 Chapel Hill, North Carolina, United States