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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447886
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : June 11, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute

Study Description
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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

Condition or disease Intervention/treatment
Breast Cancer Other: Phone interview

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
Study Design
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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Other
Time Perspective: Other
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
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Quality Of Life

This study uses qualitative research methods, specifically semi-structured interviews.

  • This will include moderator guide development,
  • Phone interviews with breast cancer survivors will be conducted
  • Qualitative data analysis of the phone interviews will be conducted
 Other: Phone interview
Collecting clinical and socio-demographic information.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women of all races
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447886


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rachel A Freedman, MD, MPH Dana-Farber Cancer Institute
More Information
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Responsible Party: Rachel Freedman, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03447886    
Other Study ID Numbers: 17-581
U54CA156732 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases