Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older

Study Overview
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Brief Summary
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To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.

Detailed Description
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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.

Official Title
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LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older

Conditions
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Aging, Breast Cancer, Physical Activity

Intervention / Treatment
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* Behavioral: Walk with Ease Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Cohort<br>Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention. | Behavioral: Walk with Ease Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 2 - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure changes in body compositional aspects of lean body mass (LBM) | As measured by DEXA | 12 months | 
| To measure changes in body compositional aspects of fat tissue mass (FM) | As measured by DEXA | 12 months | 
| To measure changes in body compositional aspects of percentage body fat (BF) | As measured by DEXA | 12 months | 
| To measure change in physical activity over the course of the study | As measured by engagement in walking survey | 12 months | 
| To measure change in physical function over the course of the study | As measured by the Short Physical Performance Battery | 12 months | 
| To measure change in fatigue over the course of the study | As measured by the FACIT-F | 12 months | 
| To measure change in quality of life over the course of the study | As measured by the FACT-B | 12 months | 
| To measure change in self-efficacy over the course of the study | As measured by the PSEFSM and OEE | 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. | 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. | 12 months | 
| To measure overall satisfaction with the program | As measured by a satisfaction questionnaire | 12 months | 
| To average the number of daily and weekly steps per participant | As measure via an continuous accelerometer. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Breast Cancer, Geriatric, Advance Age, Exercise, Physical Activity, Genetic Marker, p16, Chemotherapy, Breast Cancer Treatment