Compliance to a Hormone Therapy Regimen in Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666822
• Other study ID #: CASE6107
• Secondary ID: P30CA043703CASE6
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: February 4, 2016
• Start date: December 2007
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2015
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• compliance monitoring
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.

Other:
• medical chart review
Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.
• questionnaire administration
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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to endocrine therapy		at 5 yrs	No
Primary	Effects of categorical predictors of compliance		at 5 yrs	No
Primary	Comparison of the means of each continuous predictor between compliers and non-compliers		at 5 yrs	No
Primary	Effects of continuous and categorical variables on compliance, controlling for other factors including age at diagnosis, race, education, and type of surgery		5 yrs	No
Secondary	Time to discontinuation of tamoxifen as a time-to-event outcome		5 yrs	No
Secondary	Univariate and multivariate associations of covariates with risk of noncompliance		5 yrs	No