NCT02677857

Developing a Healthy Lifestyle in Breast Cancer Survivors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: The University of Tennessee, Knoxville · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I \[\> 1 cm\], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in \> 8 hours a day of SB) and inactive (engage in \< 100 min/wk MVPA) to one of three, 3-month conditions: 1. lifestyle intervention (Lifestyle) (increase MVPA to \> 200 min/wk); 2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to \> 200 min/wk and reduce SB by 2 hrs/day); or 3. weight management education materials provided via mailed newsletter (Newsletter). Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie \[1200-1500 kcal/day\], low-fat \[\<30% calories from fat\]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness.

Conditions

• Breast Cancer
• Sedentary Lifestyle

Interventions

Type	Name	Description
BEHAVIORAL	Common intervention components for Lifestyle	Participants in these conditions will receive standard care and one of the Lifestyle conditions. There are several components that will be identical for both Lifestyle conditions. These components include treatment structure, dietary goals, and cognitive behavioral strategies.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-02-09
• Last updated: 2018-04-05

Locations

1 site across 1 country: United States