Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
Primary Purpose
Metastatic Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walk with Ease
Sponsored by

About this trial
This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring physical activity, chemotherapy, fatigue
Eligibility Criteria
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.
Sites / Locations
- UNC Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Walk with Ease physical activity intervention
Outcomes
Primary Outcome Measures
changes in fatigue scores
Evaluate change in PROMIS Fatigue scores from baseline to 3 months
Secondary Outcome Measures
Full Information
NCT ID
NCT02682836
First Posted
February 10, 2016
Last Updated
January 4, 2022
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02682836
Brief Title
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
Official Title
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
physical activity, chemotherapy, fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
Walk with Ease physical activity intervention
Intervention Type
Behavioral
Intervention Name(s)
Walk with Ease
Primary Outcome Measure Information:
Title
changes in fatigue scores
Description
Evaluate change in PROMIS Fatigue scores from baseline to 3 months
Time Frame
at 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten A Nyrop, PhD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Cancer Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36398879
Citation
Shachar SS, Heiling H, Muss HB, Meghan D, Wagoner CW, Deal AM, Nyrop KA. Physical Activity Intervention in Patients with Metastatic Breast Cancer During Active Treatment: Quality of Life and Function. Oncologist. 2023 Jan 18;28(1):84-e70. doi: 10.1093/oncolo/oyac232.
Results Reference
derived
Learn more about this trial
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
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