Educational Interventions for Patients With DCIS

NCT ID: NCT00148655

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-08-31

Brief Summary

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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

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* 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.

Conditions

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DCIS

Keywords

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educational intervention decision board DCIS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Decision Board

Decision board that explains the risks and benefits of treatment options

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Dana-Farber Cancer Institute

Principal Investigators

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Eric Winer, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Center

Boston, Massachusetts, United States

Site Status

Faulkner Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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02-331

Identifier Type: -

Identifier Source: org_study_id