Clinical trial NCT03447886: Understanding Barriers to Initiation and Adherence to Endocrine Therapy in Young Breast Cancer Survivors of Diverse Backgrounds
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-02-27
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women of all races

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

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

Primary outcomes:
measure: Decision-making around endocrine therapy in young women with HR+ breast cancer.
timeFrame: 3 months-3 years post active treatment
Secondary outcomes:
measure: Barriers and challenges to endocrine therapy adherence
timeFrame: 3 months-3 years post active treatment
measure: Social support
timeFrame: 3 months-3 years post active treatment
measure: Health behaviors
timeFrame: 3 months-3 years post active treatment
measure: Endocrine therapy adherence intervention preferences
timeFrame: 3 months-3 years post active treatment
measure: Health literacy
timeFrame: 3 months-3 years post active treatment
measure: Menopausal symptoms
timeFrame: 3 months-3 years post active treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rachel A Freedman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: