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 Details — Status: Completed

Administrative data

• NCT number: NCT02682836
• Other study ID #: LCCC1537
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2022
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Behavioral:
• Walk with Ease

Locations

Country	Name	City	State
United States	UNC Cancer Hospital	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in fatigue scores	Evaluate change in PROMIS Fatigue scores from baseline to 3 months	at 3 months