Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
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.
Interventions
BEHAVIORALcompliance 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.
OTHERmedical chart review
Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.
OTHERquestionnaire 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.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to endocrine therapy | at 5 yrs |
| Effects of categorical predictors of compliance | at 5 yrs |
| Comparison of the means of each continuous predictor between compliers and non-compliers | 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 | 5 yrs |
Secondary
| Measure | Time frame |
|---|---|
| Time to discontinuation of tamoxifen as a time-to-event outcome | 5 yrs |
| Univariate and multivariate associations of covariates with risk of noncompliance | 5 yrs |
Countries
United States
Outcome results
None listed