Breast Cancer WEight Loss Study (BWEL Study)

Conditions

• Breast Ductal Carcinoma In Situ
• Invasive Breast Carcinoma
• Stage II Breast Cancer AJCC v6 and v7
• Stage IIB Breast Cancer AJCC v6 and v7
• Stage IIIA Breast Cancer AJCC v7
• Stage IIIC Breast Cancer AJCC v7
• Synchronous Bilateral Breast Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Health Education Program — OTHER
• Weight Loss Intervention — OTHER

Study Details

This randomized phase III trial compares whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

Key Dates

First listed

Apr 26, 2016

Start date

Sep 16, 2016

Status verified

Aug 2026

Primary completion

May 30, 2030

Completion

May 30, 2030

Study Design

Enrollment

3,177 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Arm 1: Health Education Program
  Patients will receive a standardized intervention focusing on healthy living. This will include mailings at study entry and one year later describing healthy lifestyle behaviors. All participants will also receive a 2-year subscription to a health magazine. In addition, all study participants will be invited to join twice-yearly Webinars/teleconferences that focus on breast cancer and other health topics, such as treatment updates in breast cancer, management of menopausal side effects, general cancer screening, etc. Finally, the study will also provide birthday and holiday greeting cards and a twice-yearly study newsletter with study updates and other general breast cancer news.
• Other: Arm 2: Health Education Program + Weight Loss Intervention
  Patients will receive a standardized intervention focusing on healthy living as described in the Arm 1 (Health Education Program). In addition, patients will utilize a standardized, 2-year, telephone-based weight loss intervention. The intervention will include individual weight loss, caloric restriction, and physical activity goals for each participant. It will be administered through semi-structured phone calls delivered by trained coaches at the BWEL call center and supplemented through print and on-line materials. The intervention will utilize a toolbox approach that will allow for tailoring for the individual participant.

Primary Outcome Measure

Invasive disease-free survival [ Time Frame: Up to 10 years ]

Locations (1464)