Educational Interventions for Patients With DCIS

DCIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148655
• Other study ID #: 02-331
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: December 22, 2007
• Start date: May 2003
• Est. completion date: August 2006

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• DCIS

Intervention

Device:
• Decision Board
Decision board that explains the risks and benefits of treatment options

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Center	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the impact of an educational intervention on the decision-making in women with DCIS.		3 years	No
Secondary	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	No