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Clinical Trials/NCT03447886
NCT03447886
Completed
Not Applicable

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

Dana-Farber Cancer Institute1 site in 1 country17 target enrollmentMarch 9, 2018
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Dana-Farber Cancer Institute
Enrollment
17
Locations
1
Primary Endpoint
Decision-making around endocrine therapy in young women with HR+ breast cancer.
Status
Completed
Last Updated
4 years ago

Overview

Brief 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

Detailed 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

Registry
clinicaltrials.gov
Start Date
March 9, 2018
End Date
August 27, 2018
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rachel Freedman, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Decision-making around endocrine therapy in young women with HR+ breast cancer.

Time Frame: 3 months-3 years post active treatment

Open ended questions

Secondary Outcomes

  • Barriers and challenges to endocrine therapy adherence(3 months-3 years post active treatment)
  • Menopausal symptoms(3 months-3 years post active treatment)
  • Social support(3 months-3 years post active treatment)
  • Health behaviors(3 months-3 years post active treatment)
  • Endocrine therapy adherence intervention preferences(3 months-3 years post active treatment)
  • Health literacy(3 months-3 years post active treatment)

Study Sites (1)

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