Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster

NCT03743753 | Completed

• 1 other identifier: 4844
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group. The control group will receive the current standard educational information from the surgeon along with an information package, while participants in the experimental group will also receive an additional education session before their operation about what to expect during their reconstructive journey. Satisfaction with care, anxiety about the procedure and recovery, and health related quality of life will be measured in all patients using established questionnaires. Additionally, feasibility outcomes will be reported and the results of this study will be used to demonstrate whether a larger version of this study can be successfully completed.

Conditions

Breast Reconstruction; Patient Education

Keywords

Patient education; Satisfaction; Anxiety; Quality of life; Implant; Autologous; Breast reconstruction; Alloplastic

Outcome Measures

Primary Outcomes (1)

• Feasibility of the research study as measured by retention rate

  The primary feasibility outcome will be retention rate at the 6 month-follow up. Retention rate is the percentage of enrolled participants who remain in the study until all study requirements are complete. A retention rate of \>90% will indicate that a larger scale study is feasible.

  This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up.

Secondary Outcomes (10)

• Patient Satisfaction

  This questionnaire will be administered at the 1-2 week pre-operative visit and at the 2-4 weeks, 3 months and 6 months post-operation. (Also administered 1-2 weeks before, 2-4 weeks and 3 months after the 2nd surgery for implant based reconstruction).)

• Anxiety

  This questionnaire will be administered at the 1-2 week pre-operative visit and at the 2-4 weeks, 3 months and 6 months post-operation. (Also administered 1-2 weeks before, 2-4 weeks and 3 months after the 2nd surgery for implant based reconstruction).)

• Health-related quality of life

  This questionnaire will be administered at the 1-2 week pre-operative visit and at the 2-4 weeks, 3 months and 6 months post-operation. (Also administered 1-2 weeks before, 2-4 weeks and 3 months after the 2nd surgery for implant based reconstruction).)

• Feasibility measure: Recruitment rate

  This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up.

• Feasibility measure: Compliance rate

  This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up.

Study Arms (2)

Control

NO INTERVENTION

The control group will receive the current standard educational information from the surgeon along with an information package.

Experimental

EXPERIMENTAL

The experimental group will receive an additional educational session before their operation about what to expect during their reconstructive journey, in addition to the current standard educational information from the surgeon along with an information package.

Other: Experimental

Interventions

Experimental OTHER

The intervention is the educational session, which is a one-on-one session delivered by a research assistant using a visual aide on an iPad (power point presentation). The session is specifically tailored to the method of breast reconstruction (autologous or alloplastic) the patient will undergo and reviews the basics of their reconstruction, explains the normal in-hospital course and post-operative recovery, reviews potential complications and provides advice from previous breast reconstruction patients.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years of age or older
• Able to understand and communicate in English
• Patients who will be undergoing (or have had) a unilateral or bilateral mastectomy
• Patients who will be undergoing primary breast reconstruction
• Immediate or delayed breast reconstruction
• Autologous (own tissue from the abdomen) or Alloplastic (tissue expander and implant) breast reconstruction.

You may not qualify if:

• Breast conserving surgery (lumpectomy, partial mastectomy)
• Reconstruction using only the latissimus dorsi muscle
• Combined autologous and alloplastic reconstruction (e.g. latissimus dorsi and tissue expander)
• Direct to implant reconstruction
• Autologous reconstruction using tissue from a location other than the abdomen (e.g. buttock or thigh)
• Seeking breast revision surgery or nipple reconstruction only
• Patients who are unable to provide informed consent or are unable to complete quality of life questionnaires due to mental capacity or cognitive impairment

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Personal Satisfaction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Study Officials

• Sophocles Voineskos, MD, MSc.

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The plastic surgeon will be blinded to participant's group allocation. The data analyst will also be blinded. They will be presented the data without group identification (i.e., Group A and Group B).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 16, 2018
• Study Start: May 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: August 17, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

CA (2)