DCIS
Conditions
Keywords
educational intervention, decision board, DCIS
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.
Interventions
DEVICEDecision Board
Decision board that explains the risks and benefits of treatment options
Sponsors
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the impact of an educational intervention on the decision-making in women with DCIS. | 3 years |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed