# Baseline Symptoms and Adherence to Oral Breast Cancer Therapy among Older Women

> **NIH NIH R21** · MEDICAL COLLEGE OF WISCONSIN · 2020 · $234,000

## Abstract

For the >200,000 older women who develop hormone receptor positive breast cancer yearly, adjuvant
endocrine therapy (AET) for at least five years increases overall survival. Yet almost half of patients prescribed
AET fail to take all their pills. Education- and reminder-based studies in this and a number of other settings
have had disappointingly small effects on adherence, and more complex interventions have proven difficult to
sustain. In this proposal we seek a better understanding of the symptoms that women describe as major
barriers to AET adherence. We draw on prior research suggesting that preexisting symptoms may play an
important role in patients’ experience with AET. Our proposal fills crucial gaps in our understanding by
examining older and less selected subjects treated in a usual care practice, and by using a measure that is
already routinely collected across the United States. Specifically, we will use the National Comprehensive
Cancer Network’s Distress Thermometer (DT) and its accompanying problem list, which have previously been
shown to reveal a high burden of symptoms among older women with breast cancer but have not been
examined in association with AET or while accounting for the wide spectrum of comorbid conditions of older
women. Most cancer centers administer the DT and problem list at diagnosis or earlier in care, increasing their
value for informing early intervention to help women continue their AET. We will investigate whether the DT
and problem list are predictive of AET discontinuation among older women, with specific aims as follows: Aim
1 To examine the association of patient-reported distress at diagnosis with early discontinuation of
AET. We will utilize electronic health record data from a cohort of incident postmenopausal hormone receptor
positive breast cancer patients to examine the association of the DT (scored 0 to 10) measured at diagnosis
with AET discontinuation in time-to-event analyses, accounting for age, osteoarthritis, and other comorbidities,
and other breast cancer treatments. Aim 2. To explore the association of patient-reported symptoms at
diagnosis with discontinuation of AET. In the same cohort and using the same general approach, we will
explore AET discontinuation and a) patient-reported overall symptom count based on DT problem list) and b)
symptom clusters (e.g., fatigue, sleep, concentration). We will use both standard regression and an innovative
application of machine learning using Bayesian Additive Regression Trees. With this approach, we will produce
immediately actionable findings to improve adherence outcomes, by providing a means of identifying high-risk
patients who are the primary targets for the development of new interventions. It could also be an important
model for other conditions that are treated with aggressive treatment regimens in older patients, informing care
for a large number of older patients.

## Key facts

- **NIH application ID:** 9995306
- **Project number:** 1R21AG064875-01A1
- **Recipient organization:** MEDICAL COLLEGE OF WISCONSIN
- **Principal Investigator:** Kathryn E Flynn
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $234,000
- **Award type:** 1
- **Project period:** 2020-09-15 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9995306

## Citation

> US National Institutes of Health, RePORTER application 9995306, Baseline Symptoms and Adherence to Oral Breast Cancer Therapy among Older Women (1R21AG064875-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9995306. Licensed CC0.

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