Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer (WHIP)

Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death. Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years, this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are more likely to die from their breast cancer as ER positive White women. Preliminary data suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity. To date, no study has systematically examined psychosocial, healthcare, and biological factors that predict adherence to hormonal therapy in Black women with breast cancer. To begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of 422 ER positive Black breast cancer patients recruited from health maintenance organizations (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3) Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in adherence to hormonal therapy which is novel and will increase knowledge about this genetic factor in Blacks. The study is focused on the time-period (first 3 years) when women appear to be the most vulnerable to terminating treatment prematurely. A better understanding of predictors of adherence in Black women may help target interventions and ultimately improve potentially avoidable adverse breast cancer outcomes in this underserved group.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: No Intervention

Detailed Description

Investigators will employ the Adherence Model of Behavior to identify clinical, psychosocial, and healthcare delivery predictors of longitudinal hormonal therapy adherence in women with (hormone receptor) HR positive breast cancer. This study is significant because: (1) most breast cancers in Blacks and Whites are HR positive (~75%)1,27; (2) hormonal therapy is recommend for all women with HR positive cancer since it reduces recurrence and mortality; (3) women who adhere to hormonal therapy have lower mortality than those who do not28; (4) adherence to hormonal therapy is suboptimal, even in HMO settings; (5) current guidelines recommend at least 5 years of hormonal therapy6; (6) along with Whites, investigators will examine adherence behaviors in Blacks, a group reported to have poorer outcomes than Whites, even among HR positive cases of similar stage;) past studies have documented poor adherence but few have systematically examined reasons for non-adherence. Overall, our results will be clinically useful and will inform interventions and pharmacogenetics research. For instance, if investigators find that communication strongly influences adherence, investigators can develop and implement patient self-efficacy or physician reminder-based interventions to enhance communication about adherence between patients and clinicians in HMOs. If investigators find that different factors predict adherence in Blacks versus Whites, investigators can develop tailored interventions. The PI has extensive experience developing tailored interventions to improve communication and uptake of chemotherapy in Blacks and Latinas.The next sections highlight the background that supports the significance of our research.

• Study Type: Observational
• Enrollment (Actual): 630

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Participants for this study are ER positive women over the age of 21 diagnosed with breast cancer.

Description

Inclusion Criteria:

• Non-recurrent invasive breast cancer (AJCC Stages I-IV)
• Any race
• English or Spanish speaking and/or reading
• Initiated hormonal therapy within 12 months of definitive diagnosis

Exclusion Criteria:

• HR Negative
• Under the age of 21
• Non-English or Spanish Speaking

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women Diagnosed with Breast Cancer; Observational - Usual Care	Behavioral: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to hormonal therapy at 36 months post initiation - Survey	Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy. Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence.	Baseline to end of followup - 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Factors - Medical Record Review	Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy.	Baseline to the end of follow-up - 3 years.

Collaborators and Investigators

• Sponsor: Georgetown University

Publications and helpful links

General Publications

• Edmonds MC, Sutton AL, Cummings Y, Sheppard VB. Opportunities to Improve Women's Health: Engaging Racial/Ethnic Diverse Women to Provide Biospecimens for Research. J Womens Health (Larchmt). 2021 Sep;30(9):1321-1327. doi: 10.1089/jwh.2020.8502. Epub 2021 Jan 11.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Medication Adherence
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Sheppard_WHIP_Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO