Understanding Barriers to Initiation and Adherence to Endocrine Therapy in Young Breast Cancer Survivors of Diverse Backgrounds

Breast Cancer Clinical Trial

Official title:

Understanding Barriers to Initiation and Adherence to Adjuvant Endocrine Therapy in Young Breast Cancer Survivors of Diverse Racial, Ethnic, and Socio-economic Backgrounds: The EMPOWER Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447886
• Other study ID #: 17-581
• Secondary ID: U54CA156732
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: August 27, 2018

Study information

• Verified date: June 2021
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall goal of this study is to qualitatively explore how behavioral, cultural, psychosocial, and economic barriers and facilitators affect the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer

Description:

A qualitative study that will use interviews to gain an in depth understanding of factors affecting the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Are Hispanic, Latina, Black, or identify as socio-economically disadvantaged (any racial/ethnic background) as measured by an item of financial distress answering that they are "having difficulty paying the bills no matter what they do" to a question about their current household financial situation.18, 19

• report a history of Stage 1-3 breast cancer

• reports HR+ breast cancer and confirm that they have had a discussion with their doctor about adjuvant ET; OR indicate that they are taking ET, even if they do not know their HR status, answer they are HR-, or do not recall having a discussion about ET)

• not in active treatment (e.g., chemotherapy, radiation), with the exception of Herceptin

• at least 3 months, but no more than 3 years out of completion of active treatment

• no evidence of recurrent/metastatic disease

• at least 18, but< 45 years of age at diagnosis of first invasive breast cancer

• English or Spanish speaking

• are willing to consent to the interview

Exclusion Criteria:

• HR- breast cancer and indicate they are not taking ET

• HR+ breast cancer but do not confirm discussion of ET or indicate they are taking ET

• Stage 0 (DCIS) breast cancer

• Recurrent or metastatic disease

• Less than 3 months or more than 3 years post-active treatment

• Less than 18 years old or =45 years old at diagnosis

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Phone interview
Collecting clinical and socio-demographic information.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision-making around endocrine therapy in young women with HR+ breast cancer.	Open ended questions	3 months-3 years post active treatment
Secondary	Barriers and challenges to endocrine therapy adherence	Open ended questions	3 months-3 years post active treatment
Secondary	Social support	Open ended questions	3 months-3 years post active treatment
Secondary	Health behaviors	Open ended questions	3 months-3 years post active treatment
Secondary	Endocrine therapy adherence intervention preferences	Open ended questions	3 months-3 years post active treatment
Secondary	Health literacy	Brief Health Literacy Screener (Chew items)	3 months-3 years post active treatment
Secondary	Menopausal symptoms	BCPT Symptom Checklist	3 months-3 years post active treatment