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

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ClinicalTrials.gov Identifier: NCT03679559
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Invasive Breast Carcinoma Other: Best Practice Behavioral: Exercise Intervention Other: Informational Intervention Other: Laboratory Biomarker Analysis Device: Monitoring Device Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility of conducting 12 week exercise intervention programs in breast cancer survivors who are sedentary.

SECONDARY OBJECTIVES:

I. To assess the adherence rate of each of the three 12 week intervention programs by breast cancer survivors who are sedentary.

EXPLORATORY OBJECTIVES:

I. To determine how cardiovascular fitness, body composition, nutritional choices, behavior change, biomarkers of immune function, mitochondrial function, quality of life (QoL), and cognitive function are affected by a 12 week physical activity program completed by sedentary breast cancer survivors.

II. To compare differences in these outcomes among sedentary breast cancer survivors who completed a home-based walking program versus a home-based Zumba program in a video game format versus a supervised high intensity interval training program.

OUTLINE: Participants are randomized into 1 of 4 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 continue their usual physical activity over 12 weeks.

After completion of study intervention, participants are followed up at 2 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise to Improve Health and Quality-of-Life in Breast Cancer Survivors: A Feasibility Pilot Trial
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : October 6, 2020
Estimated Study Completion Date : March 21, 2021

Resource links provided by the National Library of Medicine


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 walk 10000 steps per day over 12 weeks 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
Complete home-based walking program and resistance training

Other: Informational Intervention
Watch video

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Wear Fitbit
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

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.
Behavioral: Exercise Intervention
Complete home-based Zumba program and resistance training

Other: Informational Intervention
Watch video

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Wear Fitbit
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

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.
Behavioral: Exercise Intervention
Complete HIIT program and resistance training

Other: Informational Intervention
Watch video

Device: Monitoring Device
Wear Fitbit
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm IV (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

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Wear Fitbit
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Proportion of randomized patients who are still on study at the end of the 12 week intervention [ Time Frame: 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 :
  1. Adherence rate in each of the active intervention arms [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • 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)

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
  • Are morbidly obese with body mass index (BMI) > 40

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679559


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Tracey L. O'Connor    716-845-1486    Tracey.OConnor@Roswellpark.org   
Principal Investigator: Tracey L. O'Connor         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tracey O'Connor Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03679559     History of Changes
Other Study ID Numbers: I 32816
NCI-2018-00455 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 32816 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases