PEGI to Improve Shared Decision-Making for Breast Reconstruction
This trial is active, not recruiting.
|Treatment||pre-consultation educational group intervention|
|Sponsor||University Health Network, Toronto|
|Start date||February 2014|
|End date||September 2018|
|Trial size||156 participants|
|Trial identifier||NCT02734121, 13-7227-CE|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
Decisional Conflict Scale
time frame: Change from baseline decision conflict at 1 week after surgical consultation
Female participants at least 18 years old.
Inclusion Criteria: 1. Patients > 18 years of age. 2. Seeking consultation for delayed Post Mastectomy Breast Reconstruction, or prophylactic mastectomy and immediate Post Mastectomy Breast Reconstruction for breast cancer prevention. Exclusion Criteria: 1. Chest wall or atypical breast malignancy that require chest wall reconstruction. 2. Active invasive or in situ breast cancer. 3. Consultation for breast revision or nipple reconstruction only. 4. Patient cannot read or write in English. 5. Cognitive impairment or uncontrolled psychiatric diagnosis.
|Official title||Pre-consultation Educational Group Intervention to Improve Shared Decision-Making for Postmastectomy Breast Reconstruction|
|Principal investigator||Toni Zhong, MD, MHS|
|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 study will evaluate the educational group intervention.|
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