Educational Interventions for Patients With DCIS

Not Applicable

Completed

• Conditions: DCIS

• Registration Number: NCT00148655
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of this study is to determine whether adding an educational intervention, in the form of a decision board, which outlines the risks and benefits of treatment options for DCIS, at the time of the first surgical consultation will improve decision making for women with DCIS.

Detailed Description

* The decision board explains the risks and benefits of mastectomy, excision and radiation, excision, radiation, and tamoxifen, excision alone, and excision without radiation and tamoxifen for women with DCIS.

* Patients will receive a decision board to take home for review. Two fifteen-minute telephone interviews will be conducted, one approximately one week after enrollment and one 2 months after enrollment.

* In the phone interviews, patients will asked to complete a brief survey. This survey will ask abou DCIS in general, the patient's treatment decisions, their feelings, as well as their experience with the decision board.

* This study will take about 2 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-22
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Eligible patients will include women over the age of 25 with newly-diagnosed DCIS who are candidates for breast conserving therapy.
• Pathologic confirmation of DCIS without evidence of invasive breast cancer and mammograms showing a single suspicious focus without mammographic or clinical evidence of multicentricity.
• Patients that have not made a decision regarding management of DCIS
• Eligible for radiotherapy to breast
• Oral and written knowledge of English

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Exclusion Criteria

• Patients that have undergone mastectomy
• History of prior radiotherapy to the breast, scleroderma or systemic lupus erythematosus
• Clinically palpable disease in the axilla or contralateral breast cancer
• Co-morbidities that would render them ineligible for general anesthesia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the impact of an educational intervention on the decision-making in women with DCIS.	3 years

Secondary Outcome Measures

Name	Time	Method
To assess the effect of an intervention on 1)satisfaction with decision-making, 2)knowledge of treatment options, 3)risk assessment, 4)treatment choice, 5)factors motivating treatment choice and 6)anxiety related to diagnosis.	3 years

Trial Locations

Locations (2)

Dana-Farber Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States