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PEGI to Improve Shared Decision-Making for Breast Reconstruction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02734121
Acronym
PEGI
Enrollment
156
Registered
2016-04-12
Start date
2015-02-15
Completion date
2018-09-15
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, breast reconstruction, shared decision making, decision support intervention

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.

Interventions

BEHAVIORALpre-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

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Decisional Conflict ScaleChange from baseline decision conflict at 1 week after surgical consultationDecision 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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026