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Compliance to a Hormone Therapy Regimen in Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666822
First Posted: April 25, 2008
Last Update Posted: February 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  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 ]
  • Effects of categorical predictors of compliance [ Time Frame: at 5 yrs ]
  • Comparison of the means of each continuous predictor between compliers and non-compliers [ Time Frame: 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 [ Time Frame: 5 yrs ]

Secondary Outcome Measures:
  • Time to discontinuation of tamoxifen as a time-to-event outcome [ Time Frame: 5 yrs ]
  • Univariate and multivariate associations of covariates with risk of noncompliance [ Time Frame: 5 yrs ]

Enrollment: 178
Study Start Date: December 2007
Study Completion Date: December 2015
Primary Completion Date: September 2009 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lois C. Friedman, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00666822     History of Changes
Other Study ID Numbers: CASE6107
P30CA043703 ( U.S. NIH Grant/Contract )
CASE6107 ( Other Identifier: Case Comprehensive Cancer Center )
First Submitted: April 24, 2008
First Posted: April 25, 2008
Last Update Posted: February 5, 2016
Last Verified: February 2016

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases