Compliance to a Hormone Therapy Regimen in Breast Cancer

February 4, 2016 updated by: Case Comprehensive Cancer Center

Adherence to Endocrine Therapy in Women With Breast Cancer in Clinical Practice Settings

RATIONALE: Understanding how well patients comply with their treatment regimen may help doctors plan the best treatment and ongoing care.

PURPOSE: This clinical trial is studying whether patients comply with their hormone therapy regimen in women with estrogen receptor-positive stage I, stage II, or stage IIIA breast cancer.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

To examine the relationship between adherence to endocrine therapy and variables from the Health Belief Model (i.e., perceived risk, barriers to and benefits of adherence, and cues to action such as physician recommendation) as well as measures of patient's perceptions of patient- and family-centered care in women with estrogen receptor-positive stage I-IIIA breast cancer.

OUTLINE: Patients complete a 15 minute questionnaire on-line or by mail comprising questions of demographic and medical variables (i.e., age, race/ethnicity, marital and educational status, and medication side effects) as well as health beliefs and selected aspects of patient- and family-centered care. Data collected from the questionnaire will be stored in an Excel database.

Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44106
    - Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

DISEASE CHARACTERISTICS:

Women diagnosed with breast cancer
- Stage I-IIIA disease
Estrogen receptor (ER)-positive disease
Must have begun prescribed hormonal therapy between December 2000 and December 2002
No prior history of breast cancer

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
Able to read and understand English

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Prior breast surgery, axillary surgery, and radiotherapy to the breast or chest wall allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adherence to endocrine therapy Time Frame: at 5 yrs	at 5 yrs
Effects of categorical predictors of compliance Time Frame: at 5 yrs	at 5 yrs
Comparison of the means of each continuous predictor between compliers and non-compliers Time Frame: at 5 yrs	at 5 yrs
Effects of continuous and categorical variables on compliance, controlling for other factors including age at diagnosis, race, education, and type of surgery Time Frame: 5 yrs	5 yrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to discontinuation of tamoxifen as a time-to-event outcome Time Frame: 5 yrs	5 yrs
Univariate and multivariate associations of covariates with risk of noncompliance Time Frame: 5 yrs	5 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Lois C. Friedman, PhD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria