Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 173
- Locations
- 4
- Primary Endpoint
- Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The following study personnel will be masked to participant study arm: the staff performing DXA scan and blood processing/biomarker evaluation. The staff performing clinic measures, study staff reviewing forms and entering data, the PI and Co-Is, the statistician, study manager, and interventionists (study dieticians) will be unblinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual Care Group
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.
Intervention: Usual Care (Behavioral)
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).
Intervention: Dietary/Physical Activity intervention (Behavioral)
Outcomes
Primary Outcomes
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
Time Frame: 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).
Time Frame: 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
Time Frame: 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 Outcomes
- Body Composition-body Weight(two years post-diagnosis)
- Healthy Eating Index(five years post-diagnosis)
- C-reactive Protein Level(two years post-diagnosis)
- Body Composition-body Mass Index (BMI)(Up to 7 months from treatment onset)
- Body Composition-bone Mineral Density(two years post-diagnosis)
- Insulin Level(two years post-diagnosis)
- Body Composition-bone Mineral Density.(one year post-diagnosis)
- Body Composition-lean Bone Mass(two years post-diagnosis)
- Body Composition-body Fat(two years post-diagnosis)
- Body Composition-lean Body Mass(one year post-diagnosis)
- Fecal Microbiome(two years post-diagnosis)
- Body Composition-BMI(two years post-diagnosis)
- Quality of Life(two years post-diagnosis)
- Minutes Per Week of Moderate/Vigorous Physical Activity(five years post-diagnosis)
- Pathological Complete Response(At the time of surgical resection following initial course of chemotherapy)
- Mean Insulin Level(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year)
- Mean C-reactive Protein Level(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year)
- Mean Body Composition-body Weight(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years)
- Mean Body Composition-body Mass Index (BMI)(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years)
- Mean Body Composition-body Fat(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years)
- Body Composition-lean Body Mass(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years)
- Body Composition-bone Mineral Density(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years)
- Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years)
- Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years)
- Fecal Microbiome(Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year)