Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
- Conditions
- Breast Neoplasms
- Interventions
- Behavioral: Usual CareBehavioral: Dietary/Physical Activity intervention
- Registration Number
- NCT03314688
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 173
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Group Usual Care 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. Dietary/Physical Activity Intervention Dietary/Physical Activity intervention 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).
- Primary Outcome Measures
Name Time Method Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) 12 months after enrollment This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence.
1. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted)
2. In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)
3. In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). 24 months after enrollment This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence.
In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3)Adherence to Treatment Measured by Chemotherapy Completion Rate before initiating chemotherapy to post-chemotherapy, up to 7 months Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.
- Secondary Outcome Measures
Name Time Method Body Composition-body Weight two years post-diagnosis Assessed by measured weight
Healthy Eating Index five years post-diagnosis Assessed by food frequency questionnaire
Pathological Complete Response At the time of surgical resection following initial course of chemotherapy In the subset of patients receiving neoadjuvant chemotherapy, no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen.
C-reactive Protein Level two years post-diagnosis Assessed by fasting blood (fast of 12 hours or more).
Body Composition-body Mass Index (BMI) Up to 7 months from treatment onset Assessed from measured weight and measured height
Body Composition-bone Mineral Density two years post-diagnosis Assessed by dual energy X-ray absorptiometry (DEXA)
Insulin Level two years post-diagnosis Assessed by fasting blood (fast of 12 hours or more).
Body Composition-bone Mineral Density. one year post-diagnosis Assessed by dual energy X-ray absorptiometry (DEXA)
Body Composition-lean Bone Mass two years post-diagnosis Assessed by dual energy X-ray absorptiometry (DEXA)
Body Composition-body Fat two years post-diagnosis Assessed by dual energy X-ray absorptiometry (DEXA)
Body Composition-lean Body Mass one year post-diagnosis Assessed by dual energy X-ray absorptiometry (DEXA)
Fecal Microbiome two years post-diagnosis Assessed by stool collection.
Body Composition-BMI two years post-diagnosis Assessed from measured weight and measured height
Quality of Life two years post-diagnosis Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
Minutes Per Week of Moderate/Vigorous Physical Activity five years post-diagnosis Assessed by the modified physical activity questionnaire
Trial Locations
- Locations (2)
Yale University
🇺🇸New Haven, Connecticut, United States
Dana Farber Cancer Center
🇺🇸Boston, Massachusetts, United States