PEGI to Improve Shared Decision-Making for Breast Reconstruction

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: pre-consultation educational group intervention

• Registration Number: NCT02734121
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2015-02-15
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Primary Completion: 2018-06-15
• Status Verified: 2018-09
• Study Completion: 2018-09-15
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational group intervention	pre-consultation educational group intervention	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.

Primary Outcome Measures

Name	Time	Method
Decisional Conflict Scale	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).

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada