Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
NCT ID: NCT03743753
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-05-01
2022-08-17
Brief Summary
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Detailed Description
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The primary objective of this trial is to determine feasibility of a larger, definitive RCT. The primary outcomes will allow for an accurate assessment of recruitment, study completion, efficient resource requirements and utilization, and treatment effect size. This will not only enhance the likelihood of success of a future RCT and allow us to foresee potential issues in study design, but also provide an opportunity for patient feedback on the educational intervention. The secondary objective is to address whether the novel, pre-operative educational intervention improves satisfaction (as measured with the BREAST-Q), health-related quality of life (as measured with the PROMIS-29) and decrease anxiety (as measured with the STAI for adults) in breast reconstruction patients at compared to the standard of care.
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.The session will be provided after the patient chooses their desired method of reconstruction and signs consent for their surgery. The session is specifically tailored to the method of breast reconstruction (autologous or alloplastic) the patient will undergo. It is a one-on-one session delivered by the research assistant using a visual aide on an iPad (power point presentation). The educational session 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. The information, visual aids, and lesson plan were created after a needs assessment of McMaster University breast reconstruction patients was performed (literature review, surgeon input, and semi-structured patient interviews).
The questionnaires (BREAST-Q, PROMIS-29 and STAI) will be administered to all participants at 4 time points: trial recruitment/initial consultation or preoperative appointment (1-2 weeks before surgery), and 3 follow-up time points (2-4 weeks, 3 months, and 6 months after surgery). If the participant is undergoing two-stage implant based reconstruction, the questionnaires will also be administered 1-2 weeks before the second surgery, and 2-4 weeks and 3 months after the second surgery. Qualitative interviews will be performed at 6 months post-operation with participants in the experimental group and control group. They will explore the patient perspective to identify ways to improve the content and delivery method of pre-operative education, and if in the control group, satisfaction with the standard care and information provided.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Control
The control group will receive the current standard educational information from the surgeon along with an information package.
No interventions assigned to this group
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.
Experimental
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.
Interventions
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Experimental
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.
Eligibility Criteria
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Inclusion Criteria
2. Able to understand and communicate in English
3. Patients who will be undergoing (or have had) a unilateral or bilateral mastectomy
4. Patients who will be undergoing primary breast reconstruction
5. Immediate or delayed breast reconstruction
6. Autologous (own tissue from the abdomen) or Alloplastic (tissue expander and implant) breast reconstruction.
Exclusion Criteria
2. Reconstruction using only the latissimus dorsi muscle
3. Combined autologous and alloplastic reconstruction (e.g. latissimus dorsi and tissue expander)
4. Direct to implant reconstruction
5. Autologous reconstruction using tissue from a location other than the abdomen (e.g. buttock or thigh)
6. Seeking breast revision surgery or nipple reconstruction only
7. Patients who are unable to provide informed consent or are unable to complete quality of life questionnaires due to mental capacity or cognitive impairment
18 Years
FEMALE
Yes
Sponsors
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McMaster University
OTHER
Responsible Party
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Principal Investigators
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Sophocles Voineskos, MD, MSc.
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Juravinski Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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4844
Identifier Type: -
Identifier Source: org_study_id
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