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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Adherence to endocrine therapy

Outcome Time Frame:

at 5 yrs

Safety Issue:

No

Principal Investigator

Lois C. Friedman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE6107

NCT ID:

NCT00666822

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065