Jennifer Ligibel, MD
Obesity has long been linked to poor outcomes in various cancers, including breast cancer. Studies have shown that weight can affect a patient’s risk of recurrence and mortality, driving researchers to develop weight loss intervention techniques for this at-risk population.
The Breast Cancer Weight Loss Study (BWEL; NCT02750826) is looking to identify the relationship between obesity and recurrence in breast cancer through a phone-based weight loss intervention program. Each patient will have a health coach who will work with them over a 2-year period, as well as a toolbox of resources to guide them in crafting a lifestyle of proper nutrition and exercise.
This study is currently recruiting participants, and plans to enroll 3200 women from the United States and Canada who have been diagnosed with stage II or III breast cancer, who have completed standard therapy of the treating physician’s choice.
In an interview with OncLive
, lead investigator Jennifer Ligibel, MD, senior physician, Susan F. Smith Center for Women’s Cancer at the Dana-Farber Cancer Institute, describes the BWEL trial and the possible impact of weight loss intervention for patients with breast cancer.
OncLive: Please describe the BWEL trial.
The BWEL trial is a study that is designed to looked at the impact of a telephone-based weight loss program on the risk of breast cancer recurrence and mortality in overweight and obese women who are diagnosed with breast cancer. The trial is being conducted throughout he National Clinical Trials Network (NCTN) and the National Cancer Institute Community Oncology Research Program. The Canadian [Cancer] Trials group has also joined the effort.
The trial will enroll 3200 women from the United States and Canada who have been diagnosed with stage II or III breast cancer that have finished their standard therapy—chemotherapy, radiation, surgery—and then randomize them to a 2-year telephone-based weight loss program or to a usual care control group. The study will look at the impact of the intervention on invasive disease-free survival—so, risk of recurrence distantly and locally, second breast cancer, other new cancer primary, or death from any cause. The study will also look at overall survival and the impact of the intervention on the incidence of things such as heart disease, diabetes, looking at quality of life and weight change of patients on the trial.
Can you explain the telephone intervention?
The weight loss program is a telephone-based program, which is delivered by health coaches. The program is based on other large-scale weight loss programs like the Diabetes Prevention Program, or a study in breast cancer patients called the LISA trial. Each patient is paired with a health coach who works with them through the 2-year time period.
The telephone calls are more frequent at the beginning of the study. Patients will receive weekly calls for the first 12 weeks, then calls every other week for the next year. And then the last phase of the study in the second year of the program is really a maintenance program, so patients will receive calls once a month.
Our coaches go through a very rigorous training program where we teach them the basic program, and over the past 2 years we have worked to develop intervention materials. We had a group of individuals—people who have led large-scale weight loss trials in heart disease, in diabetes, as well as experts in nutrition and physical activity from within the cancer community—develop a core set of materials and then variations so that the coaches can work with patients to develop a more individualized weight loss program.
Could you go into a little more detail about the resources that these patients are given?
We have tools that patients will receive to help them achieve their weight loss goals. Fitbit has been a partner of the study, and so patients who are assigned to the weight loss group receive wireless scales to track their weight and activity monitors. Nestlé Health Science has also sponsored the program, and patients who are interested can receive protein meal replacements, which are shakes for breakfast or lunch. We have another group that has donated scales so that patients can weigh their food and know how much they are actually eating. This is one of the things that my patients always say to me: “I eat healthy food, but I can’t lose weight.” So, this study helps people figure out not only is the food you are eating healthy, but how much you are eating, and how many calories you are consuming each day.