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Completed

NCT Number: NCT03447886

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone Interview

Other

Collecting clinical and socio-demographic information.

Primary outcomes

  1. 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

  1. Barriers and challenges to endocrine therapy adherence

    Time frame: 3 months-3 years post active treatment

    Open ended questions

  2. Social support

    Time frame: 3 months-3 years post active treatment

    Open ended questions

  3. Health behaviors

    Time frame: 3 months-3 years post active treatment

    Open ended questions

  4. Endocrine therapy adherence intervention preferences

    Time frame: 3 months-3 years post active treatment

    Open ended questions

  5. Health literacy

    Time frame: 3 months-3 years post active treatment

    Brief Health Literacy Screener (Chew items)

  6. Menopausal symptoms

    Time frame: 3 months-3 years post active treatment

    BCPT Symptom Checklist

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2018
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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