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PEGI to Improve Shared Decision-Making for Breast Reconstruction (PEGI)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
pre-consultation educational group intervention
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, breast reconstruction, shared decision making, decision support intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational group intervention

Standard Care

Arm 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.

Routine pre-consultation education

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 6, 2016
Last Updated
September 25, 2018
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02734121
Brief Title
PEGI to Improve Shared Decision-Making for Breast Reconstruction
Acronym
PEGI
Official Title
Pre-consultation Educational Group Intervention to Improve Shared Decision-Making for Postmastectomy Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2015 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, breast reconstruction, shared decision making, decision support intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational group intervention
Arm Type
Experimental
Arm 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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Routine pre-consultation education
Intervention Type
Behavioral
Intervention Name(s)
pre-consultation educational group intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Decisional Conflict Scale
Description
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).
Time Frame
Change from baseline decision conflict at 1 week after surgical consultation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 18 years of age. Seeking consultation for delayed Post Mastectomy Breast Reconstruction, or prophylactic mastectomy and immediate Post Mastectomy Breast Reconstruction for breast cancer prevention. Exclusion Criteria: Chest wall or atypical breast malignancy that require chest wall reconstruction. Active invasive or in situ breast cancer. Consultation for breast revision or nipple reconstruction only. Patient cannot read or write in English. Cognitive impairment or uncontrolled psychiatric diagnosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni Zhong, MD, MHS
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25351455
Citation
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.
Results Reference
result
Links:
URL
http://rd.springer.com/article/10.1007%2Fs00520-014-2479-6
Description
E-publication link

Learn more about this trial

PEGI to Improve Shared Decision-Making for Breast Reconstruction

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