Decision Support Workshop for Breast Reconstruction (DSW)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
41 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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