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OpenTrials
Completed

NCT Number: NCT00666822

Compliance to a Hormone Therapy Regimen in Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adherence to endocrine therapy

    Time frame: at 5 yrs

  2. Effects of categorical predictors of compliance

    Time frame: at 5 yrs

  3. Comparison of the means of each continuous predictor between compliers and non-compliers

    Time frame: at 5 yrs

  4. 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 outcomes

  1. Time to discontinuation of tamoxifen as a time-to-event outcome

    Time frame: 5 yrs

  2. Univariate and multivariate associations of covariates with risk of noncompliance

    Time frame: 5 yrs

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2015
First posted
Apr 25, 2008
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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