Project Title ENERGY Study
Researcher Cheryl Rock, PhD, RD; Graham Colditz, MD, DrPH; Wendy Demark-Wahnefried, PhD, RD; and Tim Byers, MD, MPH
Study Summary This study will examine the effects of a program that was created to help overweight breast cancer survivors lose weight by increasing their physical activity level and developing healthier eating habits. A total of 800 women will be participating in this study across the United States at four research sites.
Who Can Participate? You can join the ENERGY study if you match ALL of these MAIN categories:
• You are a woman 21 years of age or older
• You were diagnosed with Stage Ic, II, IIIa, IIIb, or IIIc breast cancer within the past 6 months to 5 years (NOT including recurrence, DCIS or metastatic disease)
• You are overweight (BMI between 25 and 45 – to calculate your BMI copy and paste this link: http://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_cal…)
• You have finished all initial breast cancer treatments (i.e. Chemotherapy, Radiation, Herceptin). You may enroll if you are still taking a nonsteroidal antiestrogen (Tamoxifen).
• You do NOT have a history of other cancer types (non-melanoma skin cancer is OK)
• You are able to be physically active (You must be able to complete the 3 minute step test)
• You are NOT currently enrolled in another nutrition or weight loss study
• You are NOT currently pregnant or planning to become pregnant in the next 2 years
• You are willing and able to attend group meetings and stay in contact with the study staff for two years
• You live near or are willing to travel (at your own expense) to one of the following locations:
o University of California, San Diego
o Washington University School of Medicine, St. Louis, Missouri
o University of Alabama at Birmingham
o University of Colorado, Denver
After you RSVP, the research staff will contact you to ask additional questions to be sure that this study is the right fit for you.
What Does Participation Involve? If you sign up for the ENERGY study, you will be contacted by phone to answer questions about your breast cancer diagnosis and treatment, medical history, and current and past physical activity. If you appear to be eligible, and if you decide to join the study, you will be asked to go to the study site for a screening visit (described below). If the screening visit confirms your eligibility and you decide to join the study, you will then be randomly assigned (like the flip of a coin) to one of two groups.
If you are assigned to Group A, the more intense program, you:
• Will be asked to participate in a group intervention program that consists of 26 structured classes over the course of one year (weekly meetings for the first 4 months, then once every other week for 2 more months, and then once a month for the remaining 6 months).
• Will receive up to 38 short telephone calls/emails over the next two years to help you reduce your food intake and achieve the desired level of physical activity.
• Will receive quarterly newsletters that are designed to help you achieve your goals as well as give you feedback on your progress and guidance.
If you are assigned to Group B, the less intense program, you:
• Will receive two consultations with a weight loss specialist and written materials that provide information about the current guidelines for weight loss and maintenance (at the beginning of the study and 6 months later).
• Will receive 6 bi-monthly group seminars on topics related to healthy living.
• Will receive monthly short telephone calls/emails over the next two years from the study staff.
All participants will be asked to participate in a clinic visit at the beginning of the study and at 6, 12, 18, and 24 months. This will include:
• Body measurements (weight, height, waist circumference, resting pulse and blood pressure).
• Giving a blood sample (about 2 tablespoons)
• Completing questionnaires about your health and well being, feelings and attitudes, treatment side effects, and physical activity.
• A stepping test to evaluate cardiovascular fitness. This involves stepping up and down from a bench that is 8 inches high for three minutes.
• At the San Diego site only, completing an on-line questionnaire about the food you have eaten during the previous 24-hours (only at the study entry, 6 month and 24 month clinic visits).
You will also be asked to sign a medical release to permit the researchers to confirm your breast cancer diagnosis with your physician and to access relevant medical records.
The researchers need to enroll up to 800 women in this study.
Where? University of California, San Diego; Washington University School of Medicine, St. Louis, Missouri; University of Alabama at Birmingham; and University of Colorado, Denver
Survival > Existence,
Image courtesy of Sue