Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

Yale University

Status: Active, not recruiting

Conditions: Breast Neoplasms

Treatments: Behavioral: Usual Care; Behavioral: Dietary/Physical Activity intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03314688

2000020335

1R01CA207753-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.

Full description

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 172 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 before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), at two years post-diagnosis (Time 3), and at five-years post-diagnosis (Time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.

Enrollment: 173 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 completed their 2nd 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

173 participants in 2 patient groups

Usual Care Group

Active Comparator group

Description:

Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study.

Treatment:

Behavioral: Usual Care

Dietary/Physical Activity Intervention

Experimental group

Description:

Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program).

Treatment:

Behavioral: Dietary/Physical Activity intervention