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Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.

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.

Walk with Ease Program

Hyman Muss, MD

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.

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

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

The comparison group will be taken from another study

The study will look at the change of p16 expression within patients on this study.

As measured by engagement in walking survey

As measured by the Short Physical Performance Battery

• Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.

• 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.

As measured by a satisfaction questionnaire

As measure via an continuous accelerometer.

UNC Lineberger Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

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Benzocaine

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Breast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease.

Lung Cancer Patients age 60 and above who have stage I, II or III disease

Colon cancer patients age 60 and above who have stage II or III disease.

The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them.

The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program.

Walk With Ease Program

* Geriatric Assessment (GA) (Version 5)
* Functional Assessment of Cancer Therapy-General (FACT)
* Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36
* Outcome Expectations for Exercise (OEE) scale29
* Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy)
* Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35
* Visual Analog Scales (VAS)

Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis.

Collect Blood, GA and Other Survey Tools

Kirsten A Nyrop, PhD

The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.

The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program.

We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.

Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy

Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy

Feasibility will be defined as the proportion of recruited subjects who complete the 6-week WWE program.

The rate of completion of assessments will be measured at baseline, 6 weeks and end of chemotherapy treatment.

To measure the association between number of minutes walked per day and number of times per week with p16 levels.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older	NCT02328313	Breast Cancer Aging Physical Activi...	Walk with Ease ...	65 Years -	UNC Lineberger Comprehensive Cancer Center
Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy	NCT01789983	Breast Cancer Colon Cancer Lung Cancer	Walk With Ease ... Collect Blood, ...	60 Years -	UNC Lineberger Comprehensive Cancer Center
Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older	NCT02328313	Breast Cancer Aging Physical Activi...	Walk with Ease ...	65 Years -	UNC Lineberger Comprehensive Cancer Center

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