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Compliance to a Hormone Therapy Regimen in Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00666822
First received: April 24, 2008
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: compliance monitoring
Other: medical chart review
Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adherence to Endocrine Therapy in Women With Breast Cancer in Clinical Practice Settings

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Adherence to endocrine therapy [ Time Frame: at 5 yrs ] [ Designated as safety issue: No ]
  • Effects of categorical predictors of compliance [ Time Frame: at 5 yrs ] [ Designated as safety issue: No ]
  • Comparison of the means of each continuous predictor between compliers and non-compliers [ Time Frame: at 5 yrs ] [ Designated as safety issue: No ]
  • Effects of continuous and categorical variables on compliance, controlling for other factors including age at diagnosis, race, education, and type of surgery [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to discontinuation of tamoxifen as a time-to-event outcome [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • Univariate and multivariate associations of covariates with risk of noncompliance [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: December 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: compliance 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.
    Other: medical chart review
    Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.
    Other: questionnaire 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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666822

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Lois C. Friedman, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00666822     History of Changes
Other Study ID Numbers: CASE6107, P30CA043703, CASE6107
Study First Received: April 24, 2008
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014