Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer

NCT02992730 | Unknown

• 1 other identifier: Sheppard_WHIP_Study
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female

Keywords

Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Factors - Medical Record Review

  Baseline to the end of follow-up - 3 years.

Study Arms (1)

Women Diagnosed with Breast Cancer

Observational - Usual Care

Behavioral: No Intervention

Interventions

No Intervention BEHAVIORAL

No Intervention

Women Diagnosed with Breast Cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

• 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.

  PMID: 33428522 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Sample

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 14, 2016
• Study Start: April 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)