The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02167932|
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment|
|Breast Cancer Aging||Behavioral: Walk With Ease|
|Study Type :||Observational|
|Actual Enrollment :||127 participants|
|Official Title:||Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||November 30, 2016|
|Actual Study Completion Date :||November 30, 2016|
Breast Cancer Patients
Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment.
Behavioral: Walk With Ease
Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.
Other Name: WWE
- Compare the change in p16 from baseline to the end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in a previous study [ Time Frame: One Year ]Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in a previous study (LCCC810) of similar patients who did not participate in a physical activity intervention
- Measure the association of change in physical activity levels with change in with p16 levels from baseline to end of chemo and baseline to 6-months post. [ Time Frame: One year ]Information obtained through patient-reported surveys and p16 levels obtained from blood samples between baseline to 6 month post-chemotherapy
- Compare changes in p16 between patients who do and do not experience any grade 3/4 toxicities [ Time Frame: One year ]Information obtained through physician and patient reported surveys.
- Predict changes in physical function, fatigue, and quality of life over [ Time Frame: One year ]This objective will use the surveys that measure physical function, fatigue and quality of life to see if they can make any predictions about how these domains may change over the course of chemotherapy.
- Measure the association of change in physical activity levels with changes in physical function, fatigue, and quality of life measures [ Time Frame: One year ]Changes will be measured over the course of the study
- Measure the association of change in p16 levels with changes in physical function, fatigue, and quality of life measures [ Time Frame: One year ]Changes will be measured over the course of chemotherapy
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167932
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Hyman B Muss, MD||University of North Carolina|