Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

University of Florida2 sites in 1 country87 target enrollmentOctober 2012

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: University of Florida
Enrollment: 87
Locations: 2
Primary Endpoint: Change in body weight from post-intervention to follow-up
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 21 to 65
•History of stage 1, 2, or 3 breast cancer
•Completed primary treatments (chemotherapy, radiation, and/or surgical treatment) for breast cancer (with or without maintenance therapy) within the last 3 months to 5 years of providing consent
•Be willing/able to attend groups and assessments in Gainesville or Jacksonville
•BMI of 27 to 45 kg/m2
•Weight-stable, i.e., not lost/gained ≥ 10 lbs in the preceding 6 months, or since the end of primary treatment

Exclusion Criteria

•History of bariatric surgery
•Pregnant, lactating, or planning on becoming pregnant in next 12 months.
•Irritable bowel syndrome
•Serious infectious disease
•Chronic malabsorption syndrome
•Uncontrolled angina within the past 6 months
•History of musculo-skeletal or chronic lung diseases that limit physical activity
•Serum creatinin \> 1.5 mg/dL
•Uncontrolled or insulin-dependent diabetes (i.e., hemoglobin A1c\< 10 g/dL, fasting serum triglycerides \> 400 mg/dL; oral medications are not exclusionary)
•At-rest blood pressure \> 140/90 mg/Hg

Outcomes

Primary Outcomes

Change in body weight from post-intervention to follow-up

Time Frame: post-intervention (month 3), follow-up (month 9)

Change in body weight from baseline to post-intervention

Time Frame: baseline (month 0), post-intervention (month 3)

Secondary Outcomes

Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention(baseline (month 0), post-intervention (month 3))
Change in HDL Cholesterol from baseline to post-intervention(baseline (month 0), post-intervention (month 3))
Change in blood glucose control from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in caloric intake from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in body composition from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in waist circumference from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in sagittal abdominal diameter from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in physical activity from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in health-related quality of life from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in self-efficacy from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Use of weight management strategies(post-intervention (month 3))
Height(baseline (month 0))
Change in blood pressure from baseline to post-intervention.(post-intervention (month 3), follow-up (month 9))
Change in LDL cholesterol at from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in total cholesterol from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in triglycerides from baseline to post-intervention.(baseline (month 0), post-intervention (month 3))
Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in HDL Cholesterol from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in blood glucose control from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in caloric intake from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in body composition from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in waist circumference from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in sagittal abdominal diameter from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in physical activity from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in health-related quality of life from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in self-efficacy from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Use of weight management strategies at follow-up.(follow-up (month 9))
Change in blood pressure from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in LDL cholesterol at from post-intervention follow-up(post-intervention (month 3), follow-up (month 9))
Change in total cholesterol from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))
Change in triglycerides from post-intervention to follow-up.(post-intervention (month 3), follow-up (month 9))