A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions
25 Years
N/A
Female
DCIS
Trial Information
A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions
- 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
To determine the impact of an educational intervention on the decision-making in women with DCIS.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Eric Winer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
02-331
NCT ID:
NCT00148655
Start Date:
May 2003
Completion Date:
August 2006
Related Keywords:
- DCIS
- educational intervention
- decision board
- DCIS
- Carcinoma, Intraductal, Noninfiltrating
Name | Location |
|---|---|
| Faulkner Hospital | Jamaica Plain, Massachusetts 02130 |
| Dana-Farber Cancer Center | Boston, Massachusetts 02115 |
