Clinical trial · Interventional
A Decision Aid for Women With Early Stage Breast Cancer
Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
NCT00201929CI-TRIAL-00000780completedPhase 3ClinicalTrials.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)
To enhance information transfer and decision making for women with breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer Decision Board | Procedure | — | UNRESOLVED |
| Paper Decision Board | Procedure | — | UNRESOLVED |
| Standard Decision Board | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Patient comprehension
- measure
- Patient satisfaction with information transfer
Secondary outcomes (5)
- measure
- Patient satisfaction with decision making
- measure
- Physician satisfaction with information transfer
- measure
- Physician satisfaction with decision making
- measure
- Time required for administration of the instrument
- measure
- Patient preference for decision making
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: Chemotherapy Group: * Female * Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy * Axillary node dissection * Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option Surgery Group: * Female * Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy * Clinical stage I or II disease * Candidate for breast conserving surgery Exclusion Criteria: Chemotherapy Group: * Candidate for CEF chemotherapy * Clinical evidence of metastatic disease * Serious comorbidity that would preclude receiving chemotherapy treatment * Unable to speak or read English fluently (including visual impairment) * Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making Surgery Group: * Previous surgery for breast cancer * Previous breast irradiation * Pregnant * Clinical suspicion of bilateral breast cancer * Serious comorbidity that would preclude definitive surgery * Unable to speak or read English fluently (including visual impairment) * Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making
References
Publications (0)
Data not yet available
No reference posted for this study.