Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.

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).

Group Type EXPERIMENTAL

Dietary/Physical Activity intervention

Intervention Type BEHAVIORAL

Motivational counseling to follow established dietary and exercise guidelines.

Interventions

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Dietary/Physical Activity intervention

Motivational counseling to follow established dietary and exercise guidelines.

Intervention Type BEHAVIORAL

Usual Care

Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No