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

Not Applicable

Completed

• Conditions: Invasive Breast Carcinoma
• Interventions: 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); Device: Monitoring Device; Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

• Registration Number: NCT03679559
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-10-06
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-20
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm III (HIIT, resistance training)	Monitoring Device	Participants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.
Arm III (HIIT, resistance training)	Quality-of-Life Assessment	Participants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.
Arm I (home-based walking program, resistance training)	Laboratory Biomarker Analysis	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.
Arm I (home-based walking program, resistance training)	Monitoring Device	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.
Arm II (home-based Zumba program, resistance training)	Laboratory Biomarker Analysis	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.
Arm II (home-based Zumba program, resistance training)	Monitoring Device	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.
Arm III (HIIT, resistance training)	Questionnaire Administration	Participants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.
Arm V (usual physical activity)	Best Practice	Participants wear Fitbit and continue their usual physical activity over 12 weeks.
Arm I (home-based walking program, resistance training)	Exercise Intervention (home walking program and resistance training)	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.
Arm I (home-based walking program, resistance training)	Exercise Intervention (HIIT program and resistance training)	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.
Arm I (home-based walking program, resistance training)	Informational Intervention	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.
Arm I (home-based walking program, resistance training)	Quality-of-Life Assessment	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.
Arm IV (supervised moderate intensity walking program)	Exercise Intervention (HIIT program and resistance training)	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 I (home-based walking program, resistance training)	Questionnaire Administration	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.
Arm II (home-based Zumba program, resistance training)	Informational Intervention	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.
Arm III (HIIT, resistance training)	Informational Intervention	Participants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.
Arm II (home-based Zumba program, resistance training)	Exercise Intervention (home-based Zumba program and resistance training)	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.
Arm II (home-based Zumba program, resistance training)	Quality-of-Life Assessment	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.
Arm II (home-based Zumba program, resistance training)	Questionnaire Administration	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.
Arm III (HIIT, resistance training)	Exercise Intervention (HIIT program and resistance training)	Participants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.

Primary Outcome Measures

Name	Time	Method
Proportion of randomized patients who are still on study at the end of the 12 week intervention	At 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Adherence rate in each of the active intervention arms	Up to 12 weeks	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States