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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03447886

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

5.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Mar 9, 2018

Actual Primary Completion Date :

Aug 27, 2018

Actual Study Completion Date :

Aug 27, 2018

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

Decision-making around endocrine therapy in young women with HR+ breast cancer. [3 months-3 years post active treatment]
Open ended questions

Secondary Outcome Measures

Barriers and challenges to endocrine therapy adherence [3 months-3 years post active treatment]
Open ended questions
Social support [3 months-3 years post active treatment]
Open ended questions
Health behaviors [3 months-3 years post active treatment]
Open ended questions
Endocrine therapy adherence intervention preferences [3 months-3 years post active treatment]
Open ended questions
Health literacy [3 months-3 years post active treatment]
Brief Health Literacy Screener (Chew items)
Menopausal symptoms [3 months-3 years post active treatment]
BCPT Symptom Checklist

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Dana-Farber Cancer Institute
National Cancer Institute (NCI)

Investigators

Principal Investigator: Rachel A Freedman, MD, MPH, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rachel Freedman, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT03447886

Other Study ID Numbers:

17-581
U54CA156732

First Posted:

Feb 27, 2018

Last Update Posted:

Jun 11, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rachel Freedman, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute

Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jun 11, 2021