Adjuvant hormonal therapy is a critical part of routine cancer care for hormonal receptor positive breast cancers;reducing recurrence and mortality by 26 percent and 50 percent, respectively. However, adherence to hormonal therapy has been identified as a significant problem with rates as low as 50 percent. Such non-adherence has been linked to poor outcomes. Little is known about factors that explain reasons for patients'non-adherence since most studies have not prospectively collected detailed data regarding healthcare delivery or psychosocial factors. We have assembled an outstanding team of investigators to fill these gaps. The overall goal of this study is to contribute to the reduction of potential avoidable breast cancer mortality. Guided by the Adherence Model, we will conduct a longitudinal prospective cohort study of 900 Black and White women with hormonal positive breast cancer who initiate therapy and follow them for three years. We will use electronic pharmacy data to capture how long women remain on therapy before they stop treatment. After a baseline interview, we will conduct follow-up interviews at 12, 24, and 36 months to capture changes in side effects and the emergence of new co-morbidities. Detailed data from patient interviews will be merged with electronic medical records and healthcare utilization data.
Study aims are to: 1) Evaluate the contribution of clinical, healthcare delivery and psychosocial predictors of adherence;and 2) Determine if predictors identified in Aim 1 moderate and/or mediate relationships between race and adherence. In an exploratory aim we will evaluate whether CYP2D6 polymorphisms are associated with side-effects among women on Tamoxifen, and if so, determine effect size estimates for future research. We will also explore if there are racial differences in sample provision that could affect conclusions. Results from this study have the potential to fill gaps in knowledge regarding reasons for non-adherence to adjuvant hormonal therapy in both Black and White women. Data will be used to inform delivery of hormonal therapy in clinical practice, identify subgroups of patients most at risk for non- adherence, and develop behavioral interventions. Results will be broadly transportable to women with hormonal receptor positive breast cancers which account for the majority of breast cancer cases.

Public Health Relevance

The survival benefits of adjuvant hormonal therapy for women with hormonal receptor positive breast cancers are well documented. However, half of all breast cancer patients who start hormonal therapy discontinue treatment by the fifth year. Non-adherence to therapy has been shown to significantly increase mortality in breast cancer patients. Despite its importance, little is known about factors that explain why so many women fail to complete therapy. In this study, women who start hormonal therapy will be followed for 3 years of treatment to identify clinical, psychosocial, and healthcare delivery factors that predict their adherence. Because little information is known about ethnic differences in adherence to hormonal therapy, we will examine whether the predictors are similar in Black and White women. We will also explore the influence of pharmacogenetic factors and side effects. Study findings will be used to identify women most at risk for stopping treatment and to develop interventions to help women remain on therapy.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA154848-03
Application #
8465139
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Das, Rina
Project Start
2011-07-01
Project End
2016-04-30
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
3
Fiscal Year
2013
Total Cost
$485,643
Indirect Cost
$121,674
Name
Georgetown University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
049515844
City
Washington
State
DC
Country
United States
Zip Code
20057
Cabling, Mark L; Turner, Jeanine W; Hurtado-de-Mendoza, Alejandra et al. (2018) Sentiment Analysis of an Online Breast Cancer Support Group: Communicating about Tamoxifen. Health Commun 33:1158-1165
Hurtado-de-Mendoza, Alejandra; Jensen, Roxanne E; Jennings, Yvonne et al. (2018) Understanding Breast Cancer Survivors' Beliefs and Concerns About Adjuvant Hormonal Therapy: Promoting Adherence. J Cancer Educ 33:436-439
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Sheppard, Vanessa B; Hurtado-de-Mendoza, Alejandra; Song, Minna et al. (2015) The role of knowledge, language, and insurance in endorsement of cancer screening in women of African origin. Prev Med Rep 2:517-23
Sheppard, Vanessa B; Dash, Chiranjeev; Oppong, Bridget et al. (2015) Weight Changes in Black and White Women Receiving Chemotherapy Treatment for Breast Cancer. J Clin Oncol Res 3:
Sheppard, Vanessa B; O'Neill, Suzanne C; Dilawari, Asma et al. (2015) Patterns of 21-gene assay testing and chemotherapy use in black and white breast cancer patients. Clin Breast Cancer 15:e83-92
Adams, Inez; Christopher, Juleen; Williams, Karen Patricia et al. (2015) What Black Women Know and Want to Know About Counseling and Testing for BRCA1/2. J Cancer Educ 30:344-52

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