Skip to main content
Clinical Trials/NCT02734121
NCT02734121
Completed
Not Applicable

Pre-consultation Educational Group Intervention to Improve Shared Decision-Making for Postmastectomy Breast Reconstruction

University Health Network, Toronto1 site in 1 country156 target enrollmentFebruary 15, 2015
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University Health Network, Toronto
Enrollment
156
Locations
1
Primary Endpoint
Decisional Conflict Scale
Status
Completed
Last Updated
7 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 study will evaluate the educational group intervention.

Registry
clinicaltrials.gov
Start Date
February 15, 2015
End Date
September 15, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients \> 18 years of age.
  • Seeking consultation for delayed Post Mastectomy Breast Reconstruction, or prophylactic mastectomy and immediate Post Mastectomy Breast Reconstruction for breast cancer prevention.

Exclusion Criteria

  • Chest wall or atypical breast malignancy that require chest wall reconstruction.
  • Active invasive or in situ breast cancer.
  • Consultation for breast revision or nipple reconstruction only.
  • Patient cannot read or write in English.
  • Cognitive impairment or uncontrolled psychiatric diagnosis.

Outcomes

Primary Outcomes

Decisional Conflict Scale

Time Frame: Change from baseline decision conflict at 1 week after surgical consultation

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).

Study Sites (1)

Loading locations...

Similar Trials