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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03447886
Enrollment
17
Registered
2018-02-27
Start date
2018-03-09
Completion date
2018-08-27
Last updated
2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer

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

Interventions

Collecting clinical and socio-demographic information.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Decision-making around endocrine therapy in young women with HR+ breast cancer.3 months-3 years post active treatmentOpen ended questions

Secondary

MeasureTime frameDescription
Social support3 months-3 years post active treatmentOpen ended questions
Health behaviors3 months-3 years post active treatmentOpen ended questions
Barriers and challenges to endocrine therapy adherence3 months-3 years post active treatmentOpen ended questions
Health literacy3 months-3 years post active treatmentBrief Health Literacy Screener (Chew items)
Menopausal symptoms3 months-3 years post active treatmentBCPT Symptom Checklist
Endocrine therapy adherence intervention preferences3 months-3 years post active treatmentOpen ended questions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026