Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors
NCT ID: NCT03751449
Last Updated: 2022-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2019-03-25
2021-05-21
Brief Summary
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Detailed Description
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I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention in overweight or obese, sedentary, older (65 years and above) breast cancer survivors on physical function (6-minute walk test) and quality of life compared to standard of care.
SECONDARY OBJECTIVES:
I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality, sleep, anxiety, depression, source of motivation for exercise, and immune function in overweight or obese, sedentary, older (65 years and above) breast cancer survivors compared to standard of care.
EXPLORATORY OBJECTIVES:
I. To determine how body composition (dual X-ray absorptiometry \[DEXA\]) and weight maintenance are affected by a 12-week aerobic and resistance exercise training program among older (65 years and above), sedentary, overweight and obese breast cancer survivors.
II. To compare differences in the above outcomes among older (65 years and above), sedentary, overweight and obese breast cancer survivors who completed a home-based aerobic and resistance exercise training program versus those who did not receive the intervention, standard of care.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (ACTIVE TREATMENT): Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
GROUP II (WAITLIST): Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (active treatment)
Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
Educational Intervention
Receive nutrition education
Exercise Intervention
Complete home-based aerobic and resistance exercise program
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group II (waitlist)
Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
Educational Intervention
Receive nutrition education
Exercise Intervention
Complete home-based aerobic and resistance exercise program
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Educational Intervention
Receive nutrition education
Exercise Intervention
Complete home-based aerobic and resistance exercise program
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Physically inactive, defined as not meeting 150 minutes or 2 hours and 30 minutes a week of vigorous-intensity exercise
* Overweight or obese, defined as having a body mass index (BMI) between 26 kg/m\^2 and 42 kg/m\^2, inclusive
* Meeting criteria for participation in low to moderate risk exercise based on the American College of Sports and Medicine (ACSM) guideline
* Providing informed consent indicating understanding the investigational nature of this study by signing an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedures
Exclusion Criteria
* Orthopedic or neuromuscular disorders that preclude participation in exercise
* Any history of myocardial infarction (MI), angina pectoris, or congestive heart failure
* High risk for moderate exercise based on ACSM risk classification
* Pregnant or nursing
* Unwilling or unable to follow protocol requirements
* Any condition which - in the investigator?s opinion - deems the participant an unsuitable candidate to participate in this study
65 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Tracey O'Connor
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2018-01704
Identifier Type: REGISTRY
Identifier Source: secondary_id
i 67518
Identifier Type: OTHER
Identifier Source: secondary_id
i 67518
Identifier Type: -
Identifier Source: org_study_id
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