Buffalo, New York 14263


Purpose:

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.


Study summary:

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: 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.


Criteria:

Inclusion Criteria: - Men or women with a history of breast cancer who have completed treatment >= 6 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 the United States (U.S.) Center for Disease Control and Prevention?s physical activity guidelines for cancer survivors (150 minutes or 2 hours and 30 minutes a week of moderate-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


NCT ID:

NCT03751449


Primary Contact:

Principal Investigator
Tracey O'Connor
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States

Tracey L. O'Connor
Phone: 716-845-7785
Email: tracey.oconnor@roswellpark.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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