This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.
PRIMARY OBJECTIVE: I. To assess the feasibility of a physical activity intervention in young, Hispanic women with chronic post-operative pain after breast surgery for invasive breast cancer, termed post breast surgery pain syndrome (PBSPS) for this study. SECONDARY OBJECTIVES: I. To assess the preliminary efficacy of a physical activity intervention in decreasing pain in young, Hispanic women with PBSPS. II. To assess the preliminary efficacy of the physical activity intervention in increasing physical activity and improving health-related quality of life (hrQOL). OUTLINE: Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Recruitment rate (Feasibility)
This study will be considered feasible with the recruitment of 25 breast cancer patients.
Time frame: Up to 1 year
Retention rate (Feasibility)
This study will be considered feasible if 80% of patients complete all pre and post assessments.
Time frame: Up to 12 weeks
Adherence rate (Feasibility)
This study will be considered feasible if participants complete at least 4 of 5 health coaching sessions (80%).
Time frame: Up to 12 weeks
Incidence of adverse events
Safety will be tracked by the study team.
Time frame: Up to 12 weeks
Change in chronic post-surgical pain
Reducing chronic post-surgical pain will be measured using the Defense and Veterans Pain Rating Scale. Will also be assessed by Bodily Threat Monitoring Scale and pain self-efficacy questionnaire. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests.
Time frame: At 13 weeks
Change in physical activity
Increasing physical activity will be measured using accelerometry data using the activePAL activity monitor. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests.
Time frame: At 13 weeks
Change in health-related quality of life (hrQOL)
Improvement in hrQOL will be measured using Patient-Reported Outcomes Measurement Information System surveys. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests.
Time frame: At 13 weeks
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