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

NCT03447886 | Completed

• 2 other identifiers: 17-581U54CA156732
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Decision-making around endocrine therapy in young women with HR+ breast cancer.

  Open ended questions

  3 months-3 years post active treatment

Secondary Outcomes (6)

• Barriers and challenges to endocrine therapy adherence

  3 months-3 years post active treatment

• Social support

  3 months-3 years post active treatment

• Health behaviors

  3 months-3 years post active treatment

• Endocrine therapy adherence intervention preferences

  3 months-3 years post active treatment

• Health literacy

  3 months-3 years post active treatment

Study Arms (1)

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

Interventions

Phone interview OTHER

Collecting clinical and socio-demographic information.

Quality Of Life

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women of all races

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel A Freedman, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: March 9, 2018
• Primary Completion: August 27, 2018
• Study Completion: August 27, 2018
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)