Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

Study Overview
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Brief Summary
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This is a prospective observational study designed to determine the feasibility and acceptability of objectively measuring physical activity, sedentary time, and sleep using the Fitbit Charge HR wristband. 50 patients who have been diagnosed with breast cancer and are planning to initiate chemotherapy will be invited to participate in this study, and we will measure general and breast-specific quality-of-life using Patient-Reported Outcomes Measurement Information System (PROMIS) measures for 3-6 months after completion of chemotherapy.

Detailed Description
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Over 3.1 million women are currently living with a diagnosis of breast cancer in the United States (US), representing 41% of all female cancer survivors in the US. The increased breast cancer survival rate has necessitated a shift in cancer care toward developing interventions to empower patients to improve their quality-of-life, and perhaps prognosis, during and after treatment. Among women diagnosed with early-stage (I or II) breast cancer, around 40% will receive chemotherapy. Among women diagnosed with late-stage (III or IV), around 75% will receive chemotherapy. Adjuvant chemotherapy is associated with many side effects, including fatigue, nausea, disturbed sleep, decreased activity, and weight gain. Women receiving chemotherapy gain an average of 2.5 to 6.2 kg during therapy. Weight gain increases the risk of breast cancer recurrence and mortality, as well as cardiovascular disease, diabetes, and second primary cancers. Physical activity alleviates or reduces both short and long term treatment side effects of chemotherapy, including weight gain, and restores physical functioning in breast cancer patients. Additionally, randomized controlled trials in breast cancer patients have shown that adding exercise to chemotherapy programs can improve breast cancer outcomes. Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. Existing research has relied on self-reported activity levels, which is a poor measure of low-intensity activities and can only capture a periodic snap shot of activity levels. This study will provide objective physical activity data across the entirety of the patient's chemotherapy treatments. This in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent physical activity declines.

Official Title
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Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have been diagnosed with breast cancer be planning to initiate chemotherapy for breast cancer at University of California, San Francisco (UCSF) be able to speak and read English, or have a family member or friend who can assist in translating and completing surveys in English be able to walk unassisted be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet Exclusion Criteria: We will exclude individuals who cannot speak or read English unless they have a friend or family member who can assist in translating and completing quality of life surveys in English. In addition, the Fitbit® requires the ability to connect to the Internet and input data in a website, therefore we will exclude patients with no regular access to the Internet or who are unable to fill out forms on the web or navigate websites. We will exclude patients who are unable to walk unassisted.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence, defined at the percentage of weeks that a participant successfully syncs their Fitbit at least once a week during the course of the study, will be reported as a point estimate and 95% confidence interval | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - Physical Function | Mean of PROMIS physical functioning questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Anxiety | Mean of PROMIS anxiety questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Depression | Mean of PROMIS depression questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Fatigue | Mean of PROMIS fatigue questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Applied cognition general concerns | Mean of PROMIS applied cognition general concerns questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Social roles | Mean of PROMIS social roles questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Applied cognitive abilities | Mean of PROMIS applied cognitive abilities questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | 12 months from start of chemotherapy | 
| Quality of Life - Sleep disturbance | Mean of PROMIS sleep disturbance questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Sleep-related impairment | Mean of PROMIS sleep-related impairment questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Pain interference | Mean of PROMIS pain interference questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Quality of Life - Exercise Vital Sign | Mean of the Exercise Vital Sign (A patient reported measure of the average minutes of moderate or greater physical activity they engage in per week) at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported. | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. | 
| Body Size | Body mass index (BMI) will be calculated at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and at 6 months following chemotherapy. | Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. |