Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment pre-consultation educational group intervention
Sponsor University Health Network, Toronto
Start date February 2014
End date September 2018
Trial size 156 participants
Trial identifier NCT02734121, 13-7227-CE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
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
(No Intervention)
Routine pre-consultation education

Primary Outcomes

Measure
Decisional Conflict Scale
time frame: Change from baseline decision conflict at 1 week after surgical consultation

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Pre-consultation Educational Group Intervention to Improve Shared Decision-Making for Postmastectomy Breast Reconstruction
Principal investigator Toni Zhong, MD, MHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.