PEGI to Improve Shared Decision-Making for Breast Reconstruction

Breast Cancer Clinical Trial

— PEGI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734121
• Other study ID #: 13-7227-CE
• Status: Completed
• Phase: N/A
• Start date: February 15, 2015
• Est. completion date: September 15, 2018

Study information

• Verified date: September 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• pre-consultation educational group intervention
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

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, Hofer SO, O'Neill AC, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot rand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline decision conflict at 1 week after surgical consultation

External Links

•   E-publication link