Clinical trial NCT00666822: Compliance to a Hormone Therapy Regimen in Breast Cancer
Official title: Adherence to Endocrine Therapy in Women With Breast Cancer in Clinical Practice Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-25
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to endocrine therapy
timeFrame: at 5 yrs
measure: Effects of categorical predictors of compliance
timeFrame: at 5 yrs
measure: Comparison of the means of each continuous predictor between compliers and non-compliers
timeFrame: at 5 yrs
measure: Effects of continuous and categorical variables on compliance, controlling for other factors including age at diagnosis, race, education, and type of surgery
timeFrame: 5 yrs
Secondary outcomes:
measure: Time to discontinuation of tamoxifen as a time-to-event outcome
timeFrame: 5 yrs
measure: Univariate and multivariate associations of covariates with risk of noncompliance
timeFrame: 5 yrs
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Lois C. Friedman, PhD
role: PRINCIPAL_INVESTIGATOR
References: