Clinical trial · Interventional
A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer
A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study
NCT06813053CI-TRIAL-00125726active not recruitingN/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)
This is a study to assess the feasibility and acceptability of a novel decision aid (DA) in a newly diagnosed, early-stage breast cancer population. Insights gained from patient feedback and the implementation process will be used to improve the information delivered in the decision aid itself and to plan for a larger scale trial to compare the decision aid to standard of care.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Aid (DA) | Other | — | UNRESOLVED |
| Standard of Care (SOC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional Group
- description
- Newly detected, early stage breast cancer patients in the treatment group will be provided an electronic copy of the DA for their reference via email.
- interventionNames
- Other: Decision Aid (DA)
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Newly diagnosed, early stage breast cancer patients in the control group will be provided an electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.
- interventionNames
- Other: Standard of Care (SOC)
Primary outcomes (2)
- measure
- Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women age 18-100 * English speaking * Clinical stage 0-III breast cancer * Eligible for both lumpectomy and mastectomy Exclusion Criteria: * Prior surgical consultation regarding treatment options for breast cancer * Previous history of breast cancer * Requires neoadjuvant chemotherapy prior to surgical intervention
References
Publications (0)
Data not yet available
No reference posted for this study.