PEGI to Improve Shared Decision-Making for Breast Reconstruction

NCT ID: NCT02734121

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-15
• Study Completion Date: 2018-09-15

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

pre-consultation educational group intervention

Intervention Type: BEHAVIORAL

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

Standard Care

Routine pre-consultation education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toni Zhong, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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 randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29.

Reference Type: RESULT

PMID: 25351455 (View on PubMed)

Related Links

http://rd.springer.com/article/10.1007%2Fs00520-014-2479-6

E-publication link

Other Identifiers

13-7227-CE

Identifier Type: -

Identifier Source: org_study_id