N/A
N=41
Decision Support Workshop for Breast Reconstruction
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01857882 ↗Enrolled (actual)
41
Serious AEs
—
Results posted
Jun 2015
Primary outcome: Primary: Decision Self-efficacy Scale — 5.7; 5.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Support Workshop (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University Health Network, Toronto
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decision Self-efficacy Scale |
5.7; 5.1 | — |
| SECONDARY Decision Conflict Scale |
— | — |
| SECONDARY Decision Preference and Decision Choice |
— | — |
| SECONDARY Patient Involvement in Care Scale (PICS) |
— | — |
| SECONDARY Satisfaction With Information (Sub-scale of BREAST-Q) |
— | — |
| SECONDARY Qualitative Interview Assessment |
— | — |
| SECONDARY Uptake Rate of Breast Reconstruction-Service Outcome |
— | — |
| SECONDARY Length of Consultation-service Outcome |
— | — |
| SECONDARY Number of Consultations-service Outcomes |
— | — |
| SECONDARY Breast Reconstruction Knowledge Test |
— | — |
| SECONDARY Medical Outcomes Study Social Support Survey |
— | — |
Summary
The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.
Eligibility Criteria
Inclusion Criteria
- Patient age: 18 - 79 years at the time of consultation
- In situ or invasive biopsy confirmed breast adenocarcinoma
- Considered for immediate or delayed breast reconstruction
- First consultation for breast reconstruction
Exclusion Criteria
- Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast
- Completion any phase of reconstruction, or for revision reconstruction
- Patient cannot read or write in English.
- Cognitive impairment or uncontrolled psychiatric diagnosis
Data sourced from ClinicalTrials.gov (NCT01857882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.