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This is a one-arm intervention study that includes assessments and questionnaires at several time points as early stage breast cancer patients undergo chemotherapy and at 6 months post-chemotherapy. Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits to evaluate engagement in physical activity. Study participants will complete questionnaires, an exercise log, and submit blood samples as multiple time points.

Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits. Participants will also complete a daily exercise log to record the total number of minutes walked and the total number of steps from the FitBit.

Engagement in Physical Activity

Study participants will complete the following questionnaires: Health Behavior Questionnaire (HBQ), Short Physical Performance Battery (SPPB), Functional Assessment of Cancer Therapy-General (FACT-G), 4.4.5 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), PROMIS Cognitive Function (Short Form 8a), Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) Version 4, Nutrition Survey, Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM),

Questionnaires

Kirsten Nyrop, PhD

Erin O Kelly

Amy Garrett, MA, CCRC

Hyman B. Muss, MD

Kirsten A. Nyrop, PhD

Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy.

Participants: 100 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy.

Procedures: The study entails screening, recruiting and consenting 100 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.

The overall focus of this study remains the investigation of associations between p16 and assessments (independent and patient-reported) of chemotherapy-related toxicity (adverse events and symptoms) and patient-reported measures of function and quality of life. The research team has determined that p16 increases dramatically during chemotherapy and that p16 levels among persons of similar age are lower among those who exercise as compared to those who are sedentary. The research team hypothesizes that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, the study proposes to build on a completed trial, LCCC1334, and enroll 100 evaluable patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in an intervention that entails both aerobic and resistance exercises.

Results from both LCCC1334 and the proposed study, LCCC1749, will be used to provide evidence for a future grant application to conduct a randomized controlled trial in a larger study population to (1) establish the effect of physical activity on p16 levels during chemotherapy and (2) further evaluate how baseline and post-chemotherapy p16 levels correlate with measures of treatment-related toxicity and patient-reported outcomes over time. Findings from this study will also provide preliminary evidence for further investigations of the potential benefits of exercise during early breast cancer chemotherapy for (1) reducing the incidence and severity of peripheral neuropathy and (2) managing the interface of fatigue and perceived cognition deficits.

Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging

Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging and Patient-reported Symptoms and Outcomes

Evaluate the association of p16 with body composition measures (Bioimpedence, DEXA or BMI) at baseline and over time. p16 is the outcome of interest. We will analyze the correlation between p16 and (1) DEXA or (2) BMI or (3) bioimpedence -- BMI will be available for all participants, while DEXA and bioimpedence measures will not necessarily be available for all participants.

Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention

Compare the change in p16 from baseline to end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention.

Will upload Fitbit and collect strength training data to evaluate the association of physical activity levels (Fitbit steps) with change in p16 levels.

Will administer the NHANES Nutrition Survey at several time points during the study. The NHANES survey is not a scale. It is not scored. It is descriptive, asking about the frequency of consumption of specific items.

Will administer the FACT/GOG-NTX instrument.

Will administer the Short Physical Performance Battery (SPPB).

Will administer the FACT-G Questionnaire. The FACT-G is scored in a Likert-type scale from 0+not at all to 4=very much. Higher scores signify higher quality of life. Subscales are physical, social/family, emotional and functional -- which are analyzed separately and can be combined into a total FACT-G score.

Will administer the FACIT-F Questionnaire. This Likert-type scale ranges from 0=not at all to 4=very much, with higher scores signifying higher fatigue. No subscales.

Will administer the MHI-17 Health Questionnaire. This 17 item measure consists of two subscales -- Anxiety and Depression. The Likert-type scale ranges from 0=all of the time to 5=none of the time. Higher scores indicate higher anxiety or depression. The two subscales are not combined into one MHI score.

Administer the MOS Social Activity Limitation Questionnaire. We are using only one item from this scale. Likert-type scoring is 0=all of the time to4=none of the time. Higher score signifies less interference with social activities.

Administer the PROMIS Instrumental Support Questionnaire. This Likert-type scale is from 1=never to 5=always. Higher score signifies higher instrumental support. No subscales.

Administer PROMIS Social Isolation Questionnaire. Likert-type scoring is 0=never to 5=alwayse. Higher score signifies more social isolation. No subscales.

Administer PROMIS Global Health Questionnaire. Likert-type scale from 0=excellent to 4=poor. Higher score signifies lower global health. No subscales.

Will administer the PROMIS Cognitive Function-Short Form (8a). This Likert-type scale is from 1=very often to 5=never. Higher scores signify higher cognitive function. No subscales.

Will administer the Blessed Memory Concentration test (BOMC).

Administer the Medical Outcomes Survey. Likert-type scale from 0=without help to 2=completely unable. Higher score signifies more limitations. No subscale.

Administer the Instrumental Activities of Daily Living Survey. This Likelrt-type scale is from 0=without help to 2=completely unable. Higher scores signify greater limitations. No subscale.

Administer the Karnofsky Performance Status

One question will inquire about falls within the past 6 months.

One question will inquire whether the participant's health limits their ability to walk one block = range 0=limited a lot to 2=not limited at all

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging	NCT03761706	Breast Cancer	Engagement in P... Questionnaires	21 Years - 64 Years	UNC Lineberger Comprehensive Cancer Center
Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging	NCT03761706	Breast Cancer	Engagement in P... Questionnaires	21 Years - 64 Years	UNC Lineberger Comprehensive Cancer Center

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