Exercise and Nutrition Intervention in Older Breast Cancer Survivors - The WIN CA Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log.
Study Overview
Brief Summary
This trial studies how well exercise and nutrition education work in improving physical function and quality of life in older breast cancer survivors. Exercise and nutrition education may help to improve the level of fitness, cardiovascular health, and quality of life in breast cancer survivors.
Detailed Description
PRIMARY OBJECTIVES:
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women with a history of breast cancer who have completed treatment >=3 months ago (not including hormonal therapy, Zometa, or other non-chemotherapy/radiation cancer treatment at the discretion of the principal investigator)
- •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
- •Metastatic breast cancer
- •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
Outcomes
Primary Outcomes
Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log.
Time Frame: Up to 2 years
Will measure the effect on physical function (6-minute walk test). Activity levels for all participants will be collected using the Fitbit applications and/or a weekly activity log.
Quality of life as assessed by the Self Geriatric Assessment Measure (GA-Self Assessment)
Time Frame: Up to 2 years
Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on quality of life.
Secondary Outcomes
- Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Up to 2 years)
- motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2)(Up to 2 years)
- Diet quality as assessed by the ASA24 website(Up to 2 years)
- Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention(Up to 2 years)
- Centers for Epidemiologic Studies Depression Scale (CESD-R)(Up to 2 years)