Clinical trial · Interventional
Educational Interventions for Patients With DCIS
A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions
NCT00148655CI-TRIAL-00001066completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Board | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the impact of an educational intervention on the decision-making in women with DCIS.
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.