To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
134
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.
Amy Garrett
Chapel Hill, North Carolina, United States
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
Time frame: 12 months
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.
Time frame: 2 - 6 months
To measure changes in body compositional aspects of lean body mass (LBM)
As measured by DEXA
Time frame: 12 months
To measure changes in body compositional aspects of fat tissue mass (FM)
As measured by DEXA
Time frame: 12 months
To measure changes in body compositional aspects of percentage body fat (BF)
As measured by DEXA
Time frame: 12 months
To measure change in physical activity over the course of the study
As measured by engagement in walking survey
Time frame: 12 months
To measure change in physical function over the course of the study
As measured by the Short Physical Performance Battery
Time frame: 12 months
To measure change in fatigue over the course of the study
As measured by the FACIT-F
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To measure change in quality of life over the course of the study
As measured by the FACT-B
Time frame: 12 months
To measure change in self-efficacy over the course of the study
As measured by the PSEFSM and OEE
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
To measure overall satisfaction with the program
As measured by a satisfaction questionnaire
Time frame: 12 months
To average the number of daily and weekly steps per participant
As measure via an continuous accelerometer.
Time frame: 12 months