Educational Interventions for Patients With DCIS

Dana-Farber Cancer Institute120 enrolled

Overview

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.

* 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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

120

Conditions

DCIS

Interventions

Decision BoardDEVICE

Decision board that explains the risks and benefits of treatment options

Eligibility

Sex: FEMALEMin age: 25 Years

Medical Language ↔ Plain English

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

Locations (2)

Dana-Farber Cancer Center

Boston, Massachusetts, United States

Faulkner Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

To determine the impact of an educational intervention on the decision-making in women with DCIS.

Time frame: 3 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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