An interventional study of pre-consultation educational group intervention in Breast Cancer, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-26.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Supportive care
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 156 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
The pre-consultation educational group intervention will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
Behavioral: pre-consultation educational group intervention
Routine pre-consultation education
Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients. * Surgeon (40 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities * Registered nurse (20 mins): preparing for surgery, postoperative recovery and how to navigate the health care system * Social worker (30 mins): values clarification exercise * Breast reconstruction patient volunteers (30 mins) questions and answers about their personal experience
Decisional Conflict Scale
Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).
Time frame: Change from baseline decision conflict at 1 week after surgical consultation
Plan to share: No
Ran from Feb 2015 to primary completion in Jun 2018, 40 months.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 40 months is above that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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