- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02682836
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
January 4, 2022 updated by: UNC Lineberger Comprehensive Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27519
- UNC Cancer Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single arm
Walk with Ease physical activity intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in fatigue scores
Time Frame: at 3 months
|
Evaluate change in PROMIS Fatigue scores from baseline to 3 months
|
at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kirsten A Nyrop, PhD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
February 10, 2016
First Submitted That Met QC Criteria
February 12, 2016
First Posted (Estimate)
February 15, 2016
Study Record Updates
Last Update Posted (Actual)
January 6, 2022
Last Update Submitted That Met QC Criteria
January 4, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC1537
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of North Carolina, Chapel HillCompletedBreast Cancer | Joint PainUnited States
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