Compliance to a Hormone Therapy Regimen in Breast Cancer

NCT00666822 | Completed

• 2 other identifiers: CASE6107P30CA043703
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Interventions

compliance monitoring BEHAVIORAL

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.

medical chart review OTHER

Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.

questionnaire administration OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lois C. Friedman, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (1)