Educational Interventions for Patients With DCIS - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 7, 2005

Last Updated Date

December 22, 2007

Start Date ^†

May 2003

Current Primary Outcome Measures ^†

To determine the impact of an educational intervention on the decision-making in women with DCIS. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00148655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Educational Interventions for Patients With DCIS

Official Title ^†

A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Other, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Condition ^†

DCIS

Intervention ^†

Device: Decision Board

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

120

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Female

Ages

25 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00148655

Responsible Party

Eric Winer, MD, Dana-Farber Cancer Institute

Secondary IDs ^††

Study Sponsor ^†

Dana-Farber Cancer Institute

Collaborators ^††

Brigham and Women's Hospital

Investigators ^†

Principal Investigator:

Eric Winer, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.