Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | January 2, 2018 |
| End Date: | December 31, 2022 |
| Contact: | Brenda Cartmel, Ph.D. |
| Email: | brenda.cartmel@yale.edu |
| Phone: | 203 764 9083 |
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
The proposed study is a randomized trial evaluating the impact of a dietary and physical
activity guidelines intervention vs. usual care on adherence to breast cancer treatments,
body composition, and changes in biomarkers in 250 women newly diagnosed with breast cancer
scheduled to receive neoadjuvant or adjuvant chemotherapy.
activity guidelines intervention vs. usual care on adherence to breast cancer treatments,
body composition, and changes in biomarkers in 250 women newly diagnosed with breast cancer
scheduled to receive neoadjuvant or adjuvant chemotherapy.
Currently the Department of Health and Human Services, the American Cancer Society and others
provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do
not follow these guidelines, and also elect to delay concerted efforts toward following them
until active treatment is complete. However, adoption of these recommended lifestyle
behaviors soon after diagnosis may prevent adverse changes in body composition and breast
cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast
cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the
association between lifestyle behaviors and breast cancer survival, this study will improve
our knowledge of how changes in diet and physical activity influence breast cancer outcomes.
Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and
cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer
mortality.
The proposed study will examine, in 250 women newly diagnosed with Stage I-III breast cancer
who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive
neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity
guidelines intervention vs. usual care on the following breast cancer outcomes measured after
surgery, but before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year
post-diagnosis (Time 2), and at two years post-diagnosis (Time 3): adherence to treatment,
and changes in biomarkers, body composition, and quality of life.
provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do
not follow these guidelines, and also elect to delay concerted efforts toward following them
until active treatment is complete. However, adoption of these recommended lifestyle
behaviors soon after diagnosis may prevent adverse changes in body composition and breast
cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast
cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the
association between lifestyle behaviors and breast cancer survival, this study will improve
our knowledge of how changes in diet and physical activity influence breast cancer outcomes.
Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and
cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer
mortality.
The proposed study will examine, in 250 women newly diagnosed with Stage I-III breast cancer
who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive
neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity
guidelines intervention vs. usual care on the following breast cancer outcomes measured after
surgery, but before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year
post-diagnosis (Time 2), and at two years post-diagnosis (Time 3): adherence to treatment,
and changes in biomarkers, body composition, and quality of life.
Inclusion Criteria:
- Diagnosed with Stage I-III breast cancer
- Scheduled to receive neoadjuvant or adjuvant chemotherapy
- Physically able to walk
- Able to complete forms, understand instructions and read intervention book in English
- Agrees to be randomly assigned to either intervention or usual care group
Exclusion Criteria:
- Women who have already initiated chemotherapy
- Women already practicing dietary or physical activity guidelines
- Are pregnant or intending to become pregnant in the next year
- Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection
fraction < 40%
- Presence of dementia or major psychiatric disease
- Non-English speaking
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