# A randomized trial of lifestyle guidelines on breast cancer biomarkers and treatment adherence

> **NIH NIH R01** · YALE UNIVERSITY · 2020 · $739,987

## Abstract

Many health organizations publish dietary and physical activity guidelines in an effort to help adults and cancer
survivors make informed choices related to nutrition and physical activity. These guidelines are based on
observational evidence showing that adhering to the guidelines improves breast cancer survival. Yet numerous
studies have reported fewer than 30% breast cancer survivors follow the dietary and physical activity
guidelines. To our knowledge, no trial has examined, in women newly diagnosed with breast cancer, the effect
of adopting and practicing the dietary and physical activity guidelines on adherence to adjuvant treatments and
cancer related biomarkers. We propose to 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 adjuvant
chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on
adherence to adjuvant breast cancer treatments including chemotherapy completion rates and adherence to
endocrine therapy. Secondary endpoints include changes in biomarkers, body composition and quality of life.
Our application is innovative and clinically meaningful as we propose to intervene soon after diagnosis when
prevalence of women following the dietary and physical activity guidelines is low and likely to worsen; examine
novel biomarkers and adherence to adjuvant treatments; and use a translational approach of intervening in the
breast clinic and via telephone to facilitate in the eventual dissemination and implementation of our
intervention. We have strong preliminary data showing a transdisciplinary team approach in recruiting breast
cancer survivors into randomized lifestyle interventions during and after treatment with high adherence to the
interventions. In summary, if we find our intervention improves adherence to breast cancer treatments,
biomarkers and body composition, then our findings could cause a paradigm shift in how breast cancer care is
delivered.

## Key facts

- **NIH application ID:** 9904562
- **Project number:** 5R01CA207753-04
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Melinda L Irwin
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $739,987
- **Award type:** 5
- **Project period:** 2017-04-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9904562

## Citation

> US National Institutes of Health, RePORTER application 9904562, A randomized trial of lifestyle guidelines on breast cancer biomarkers and treatment adherence (5R01CA207753-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9904562. Licensed CC0.

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