Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University Health Network, Toronto
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Decision Self-efficacy Scale
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed Description
Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. Failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. In such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. As a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. This pilot study will be the first step in the evaluation of the educational group intervention and the results will be used to determine the feasibility and inform the optimal design for a definitive randomized controlled trial. This study will first examine the feasibility and acceptability of the intervention through implementation in a pilot, mixed-methods, 1:1 allocation parallel-arm randomized controlled trial.
Investigators
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
Outcomes
Primary Outcomes
Decision Self-efficacy Scale
Time Frame: Change from baseline decision self-efficacy at 1 week after surgical consultation
Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy). The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation.
Secondary Outcomes
- Breast Reconstruction Knowledge Test(Change in baseline breast reconstruction knowledge at 1 week after initial consultation)
- Medical Outcomes Study Social Support Survey(baseline)
- Patient Involvement in Care Scale (PICS)(T1 (1 week after surgical consultation))
- Satisfaction With Information (Sub-scale of BREAST-Q)(T1 (1 week after surgical consultation))
- Qualitative Interview Assessment(Within three months after initial consultation)
- Decision Conflict Scale(Change from baseline decision conflict at 1 week after surgical consultation)
- Uptake Rate of Breast Reconstruction-Service Outcome(Six months after initial consultation)
- Decision Preference and Decision Choice(baseline)
- Length of Consultation-service Outcome(Duration of initial consultation)
- Number of Consultations-service Outcomes(Six months after initial consultation)