Compliance to a Hormone Therapy Regimen in Breast Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Breast Cancer

Treatments: Other: medical chart review; Behavioral: compliance monitoring; Other: questionnaire administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00666822

P30CA043703 (U.S. NIH Grant/Contract)

CASE6107 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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