Breast Cancer Clinical Trial

A Menopause Interactive Decision Aid System

Summary

The purpose of this study is to develop and test a web-based system intended to help women going through menopause make more informed choices regarding menopause treatments. The system will do this by giving women personalized feedback on the risks and benefits of these treatments.

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Full Description

Most women are not satisfied with the counseling they receive about menopause. To improve menopause counseling and help menopausal women more actively participate in the decision making process, we have developed a novel prototype web-based decision aid. Our immediate goal is to develop this prototype technology into a comprehensive Menopause Interactive Decision Aid System (MIDAS) that provides personalized feedback about menopausal symptoms, risks for common conditions, and the effects of different treatment options on the short- and long-term consequences of menopause.

Our main study hypotheses are that MIDAS can: 1) lead to better decisions and improve the quality of menopausal counseling; 2) improve compliance with a chosen menopausal plan; and 3) reduce medical errors associated with the use of menopausal therapies.

We propose a 2-phase study conducted over 3 years. Phase I will transform the prototype application into a comprehensive MIDAS, completing its content and risk assessment instruments, and exploring its optimal design. This will be accomplished through conduct of focus groups and usability tests. Phase II will formally evaluate the impact of MIDAS in a randomized, controlled, multi-center clinical trial involving diverse patient populations and clinician settings. We will measure the impact of MIDAS on the decision-making process as well as its effect on providers and outcome measures related to menopause, including compliance, quality of life, and medical errors related to menopausal therapy. Analyses will evaluate the extent to which the impact of MIDAS on these outcomes varies according to patient, practice, and physician characteristics.

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Eligibility Criteria

Inclusion Criteria:

English-speaking
Between 45 and 65 years of age
Patient at participating clinics
Experience menopausal symptoms or being 6 months or more past last menstrual period
Have an upcoming appointment for menopausal counseling or annual physical exam (only applicable for clinical trial participants)

Exclusion Criteria:

Inability to give informed consent
Dementia
Age over 65 years
Pre-existing terminal illness that limits life expectancy to less than 2 years
History of breast cancer or cardiovascular disease

Study is for people with:

Breast Cancer

Estimated Enrollment:

296

Study ID:

NCT00345072

Recruitment Status:

Unknown status

Sponsor:

Rhode Island Hospital

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There are 2 Locations for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02120, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

296

Study ID:

NCT00345072

Recruitment Status:

Unknown status

Sponsor:


Rhode Island Hospital

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