Healthy Living After Cancer: Weight Management Pilot Study

Status: Recruiting
Phase: N/A
Diagnosis: Breast: Prevention
NCT ID: NCT01978899 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-336

 

Studies have shown that patients who weigh more at the time of cancer diagnosis may be at increased risk of complications from surgery, fatigue, poor body image and other problems. Some research suggests that losing weight after cancer diagnosis can lead to improvements in these problems, as well as having other potential benefits for cancer survivors. Programs that reduce calories and increase exercise have been shown to help cancer survivors lose weight, but more research is needed to develop and test weight loss programs in cancer survivors. This study is designed to look at the ability of a 16-week diet and exercise program to help cancer survivors lose weight. The investigator will look at changes in weight, body composition, quality of life, fatigue, body image as well as diet and exercise patterns, to see if this program can help men and women feel better and live healthier lives after cancer diagnosis.

 

Conducting Institutions:
Dana-Farber Cancer Institute

Overall PI:
Jennifer Ligibel, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Casey Pereira , 617-632-5984, cpereira2@partners.org

Eligibility Criteria

Inclusion Criteria: - Written informed consent prior to any study-related procedures - History of any malignancy - Completed with all adjuvant surgery, chemotherapy and/or radiation at least one month prior to study enrollment (patients receiving ongoing hormonal or biologic therapy are eligible to participate) - BMI >25kg/m2 - ECOG performance status of 0 or 1 - At least 18 years old - Physically able to exercise and physician consent to start a weight loss program - Willingness to be randomized - English speaking and able to read English Exclusion Criteria: - Self-reported inability to walk 2 blocks (at any pace) - Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet. - Bariatric surgery within the last year - Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. - Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
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