Back to resultsImpact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Primary Purpose
Breast Cancer, Aging, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walk with Ease Program
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Cancer, Breast Cancer, Geriatric, Advance Age, Exercise, Physical Activity, Genetic Marker, p16, Chemotherapy, Breast Cancer Treatment
Eligibility Criteria
Inclusion Criteria:
- Age 65 or older, female
- Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
- Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
- English speaking
- IRB approved, signed written informed consent
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Willing and able to meet all study requirements.
Exclusion Criteria:
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
Sites / Locations
- Amy Garrett
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Cohort
Arm Description
Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.
Outcomes
Primary Outcome Measures
To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group
The comparison group will be taken from another study
To measure the changes in the level of p16 expression from baseline and end of chemotherapy.
The study will look at the change of p16 expression within patients on this study.
Secondary Outcome Measures
To measure changes in body compositional aspects of lean body mass (LBM)
As measured by DEXA
To measure changes in body compositional aspects of fat tissue mass (FM)
As measured by DEXA
To measure changes in body compositional aspects of percentage body fat (BF)
As measured by DEXA
To measure change in physical activity over the course of the study
As measured by engagement in walking survey
To measure change in physical function over the course of the study
As measured by the Short Physical Performance Battery
To measure change in fatigue over the course of the study
As measured by the FACIT-F
To measure change in quality of life over the course of the study
As measured by the FACT-B
To measure change in self-efficacy over the course of the study
As measured by the PSEFSM and OEE
To measure retention during the study
• Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.
To measure safety of the walking program
• Safety will be defined as any adverse events potentially related to the intervention, including falls, which are reported by study participants to the Study Team.
To measure overall satisfaction with the program
As measured by a satisfaction questionnaire
To average the number of daily and weekly steps per participant
As measure via an continuous accelerometer.
Full Information
NCT ID
NCT02328313
First Posted
October 21, 2014
Last Updated
April 29, 2020
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02328313
Brief Title
Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Official Title
LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
January 16, 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
To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.
Detailed Description
LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Aging, Physical Activity
Keywords
Cancer, Breast Cancer, Geriatric, Advance Age, Exercise, Physical Activity, Genetic Marker, p16, Chemotherapy, Breast Cancer Treatment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Cohort
Arm Type
Experimental
Arm Description
Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.
Intervention Type
Behavioral
Intervention Name(s)
Walk with Ease Program
Intervention Description
The Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal.
Primary Outcome Measure Information:
Title
To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group
Description
The comparison group will be taken from another study
Time Frame
12 months
Title
To measure the changes in the level of p16 expression from baseline and end of chemotherapy.
Description
The study will look at the change of p16 expression within patients on this study.
Time Frame
2 - 6 months
Secondary Outcome Measure Information:
Title
To measure changes in body compositional aspects of lean body mass (LBM)
Description
As measured by DEXA
Time Frame
12 months
Title
To measure changes in body compositional aspects of fat tissue mass (FM)
Description
As measured by DEXA
Time Frame
12 months
Title
To measure changes in body compositional aspects of percentage body fat (BF)
Description
As measured by DEXA
Time Frame
12 months
Title
To measure change in physical activity over the course of the study
Description
As measured by engagement in walking survey
Time Frame
12 months
Title
To measure change in physical function over the course of the study
Description
As measured by the Short Physical Performance Battery
Time Frame
12 months
Title
To measure change in fatigue over the course of the study
Description
As measured by the FACIT-F
Time Frame
12 months
Title
To measure change in quality of life over the course of the study
Description
As measured by the FACT-B
Time Frame
12 months
Title
To measure change in self-efficacy over the course of the study
Description
As measured by the PSEFSM and OEE
Time Frame
12 months
Title
To measure retention during the study
Description
• Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.
Time Frame
12 months
Title
To measure safety of the walking program
Description
• Safety will be defined as any adverse events potentially related to the intervention, including falls, which are reported by study participants to the Study Team.
Time Frame
12 months
Title
To measure overall satisfaction with the program
Description
As measured by a satisfaction questionnaire
Time Frame
12 months
Title
To average the number of daily and weekly steps per participant
Description
As measure via an continuous accelerometer.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65 or older, female
Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
English speaking
IRB approved, signed written informed consent
Approval from their treating physician to engage in moderate-intensity physical activity
Patient-assessed ability to walk and engage in moderate physical activity
Willing and able to meet all study requirements.
Exclusion Criteria:
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyman Muss, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amy Garrett
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
We'll reach out to this number within 24 hrs