PEGI to Improve Shared Decision-Making for Breast Reconstruction

University Health Network, Toronto

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: pre-consultation educational group intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02734121

13-7227-CE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Educational group intervention

Experimental group

Description:

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.

Treatment:

Behavioral: pre-consultation educational group intervention

Standard Care

No Intervention group

Description:

Routine pre-consultation education