Educational Interventions for Patients With DCIS

Study Overview
=================
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.

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

Conditions
-----------------
DCIS

Intervention / Treatment
-----------------
* Device: Decision Board


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Decision Board|Decision board that explains the risks and benefits of treatment options|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the impact of an educational intervention on the decision-making in women with DCIS. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DCIS, educational intervention, decision board