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

NCT ID: NCT03447886

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-09
• Study Completion Date: 2018-08-27

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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

Phone interview

Intervention Type: OTHER

Collecting clinical and socio-demographic information.

Interventions

Phone interview

Collecting clinical and socio-demographic information.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Rachel Freedman, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel A Freedman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

U54CA156732

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-581

Identifier Type: -

Identifier Source: org_study_id