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

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

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.

Study Overview

• Status: Completed
• Conditions: Invasive Breast Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: Monitoring Device; Behavioral: Exercise Intervention (home walking program and resistance training); Behavioral: Exercise Intervention (HIIT program and resistance training); Other: Informational Intervention; Behavioral: Exercise Intervention (home-based Zumba program and resistance training); Other: Best Practice

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (home-based walking program, 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: Monitoring Device; Wear Fitbit; Other Names: Monitor; Behavioral: Exercise Intervention (home walking program and resistance training); Complete home-based walking program and resistance training; Behavioral: Exercise Intervention (HIIT program and resistance training); Complete HIIT program and resistance training; Other: Informational Intervention; Watch video
Experimental: Arm II (home-based Zumba program, 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: Monitoring Device; Wear Fitbit; Other Names: Monitor; Other: Informational Intervention; Watch video; Behavioral: Exercise Intervention (home-based Zumba program and resistance training); Complete home-based Zumba program and resistance training
Experimental: Arm III (HIIT, 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: Monitoring Device; Wear Fitbit; Other Names: Monitor; Behavioral: Exercise Intervention (HIIT program and resistance training); Complete HIIT program and resistance training; Other: Informational Intervention; Watch video
Active Comparator: Arm IV (supervised moderate intensity walking program); 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); Complete HIIT program and resistance training
Active Comparator: Arm V (usual physical activity); Participants wear Fitbit and continue their usual physical activity over 12 weeks.	Other: Best Practice; Continue usual physical activity; Other Names: standard of care; standard therapy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular fitness	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Body composition	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Quality of life	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. Will be assessed by the Functional Assessment of Cancer Therapy, Breast (FACTB+4).	At baseline and 12 weeks
Cognitive function	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Stress and immune function biomarkers	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Mitochondrial function	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Ellis Levine, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: I 32816 (Other Identifier: Roswell Park Cancer Institute); NCI-2018-00455 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No