Exercise in Improving Health and Quality of Life in Breast Cancer Survivors

Study Overview
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Brief Summary
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This randomized pilot trial studies how well exercise works in improving health and quality of life in breast cancer survivors. Participating in an exercise program to maintain physical activity may help to improve health and quality of life in breast cancer survivors.

Detailed Description
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PRIMARY OBJECTIVE: I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors. SECONDARY OBJECTIVE: I. To assess the adherence rate of each of the four 12-week intervention programs by breast cancer survivors in a randomized treatment arm and a patient preference arm. OUTLINE: Participants are randomized into 1 of 5 arms. ARM I: Participants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and walk 10000 steps per day over 12 weeks in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also undergo resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands. ARM II: Participants wear Fitbit and receive a XBOX system and the video game to strive for at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target. Participants undergo resistance training as in Arm I. ARM III: Participants wear Fitbit and attend supervised High Intensity Interval Training (HIIT) exercise sessions 3 days per week over 12 weeks. Participants undergo resistance training as in Arm I. ARM IV: Participants wear Fitbit and attend supervised moderate intensity walking sessions weekly for 50-60 each over 12 weeks. Participants undergo resistance training as in Arm I. ARM V: Participants wear Fitbit and continue their usual physical activity over 12 weeks. After completion of study intervention, participants are followed up at 2 weeks and 1 month.

Official Title
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Exercise to Improve Health and Quality-of-Life in Breast Cancer Survivors: A Feasibility Pilot Trial

Conditions
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Invasive Breast Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Behavioral: Exercise Intervention (home walking program and resistance training)
* Behavioral: Exercise Intervention (home-based Zumba program and resistance training)
* Behavioral: Exercise Intervention (HIIT program and resistance training)
* Other: Informational Intervention
* Other: Laboratory Biomarker Analysis
* Device: Monitoring Device
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Have a previous history of invasive breast cancer who have completed treatment except for hormonal therapy and zoledronic acid (Zometa) Do not meet the United States (U.S.) Center for Disease Control and Prevention's physical activity guidelines (150 minutes or 2 hours and 30 minutes a week of moderate-intensity exercise) Meets criteria for participation in low to moderate risk exercise based on the American College of Sports Medicine guideline (ACSM) Exclusion Criteria: Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Are pregnant or nursing Are unwilling or unable to follow protocol requirements Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study Have metastatic breast cancer Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
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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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (home-based walking program, resistance training)<br>Participants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and brisk walk 30 minutes per day 5 days a week in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also receive resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands. | Behavioral: Exercise Intervention (home walking program and resistance training)<br>* Complete home-based walking program and resistance training<br>Behavioral: Exercise Intervention (HIIT program and resistance training)<br>* Complete HIIT program and resistance training<br>Other: Informational Intervention<br>* Watch video<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Device: Monitoring Device<br>* Wear Fitbit<br>* Other names: Monitor;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (home-based Zumba program, resistance training)<br>Participants wear Fitbit and receive a XBOX system and the video game to strive for at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target. Participants receive resistance training as in Arm I. | Behavioral: Exercise Intervention (home-based Zumba program and resistance training)<br>* Complete home-based Zumba program and resistance training<br>Other: Informational Intervention<br>* Watch video<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Device: Monitoring Device<br>* Wear Fitbit<br>* Other names: Monitor;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm III (HIIT, resistance training)<br>Participants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I. | Behavioral: Exercise Intervention (HIIT program and resistance training)<br>* Complete HIIT program and resistance training<br>Other: Informational Intervention<br>* Watch video<br>Device: Monitoring Device<br>* Wear Fitbit<br>* Other names: Monitor;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm IV (supervised moderate intensity walking program)<br>Participants wear Fitbit and attend supervised moderate intensity walking sessions weekly for 50-60 each over 12 weeks. Participants undergo resistance training as in Arm I. | Behavioral: Exercise Intervention (HIIT program and resistance training)<br>* Complete HIIT program and resistance training<br>|
| Active Comparator: Arm V (usual physical activity)<br>Participants wear Fitbit and continue their usual physical activity over 12 weeks. | Other: Best Practice<br>* Continue usual physical activity<br>* Other names: standard therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of randomized patients who are still on study at the end of the 12 week intervention | The feasibility outcomes will be assessed by a multivariable logistic regression model for the relative odds of remaining on the study (ref: not). Each of the active treatment arms will be compared to the control. The model will be supported by the randomized patient set, counting patients who withdraw from the study as feasibility failures. No variable selection steps will be taken; inferences will be based on the estimates and 95% confidence intervals from the full model. Optimism adjusted odds ratio estimates will also be reported, to better inform design of future studies. | At 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate in each of the active intervention arms | Will be defined as the proportion of patients on study after 12 weeks who complete ≥ 80% of the intervention activities. One-sided 90% Jeffrey's confidence limits will define a plausible lower limit on the range of values for true (unobserved) feasibility rate for each arm. | Up to 12 weeks |