Clinical trial NCT03743753: Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
Official title: Preoperative Education Intervention to Improve Patient Satisfaction and Optimize the Patient Experience in Breast Reconstruction: A Pilot, Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Reconstruction
Patient Education
Keywords: Patient education
Satisfaction
Anxiety
Quality of life
Implant
Autologous
Breast reconstruction
Alloplastic
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: This study is a feasibility, randomized controlled trial (RCT) to introduce a novel, pre-operative educational session for breast reconstruction patients. It will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.

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.

Eligibility criteria: Inclusion Criteria:

1. Women 18 years of age or older
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:

1. Breast conserving surgery (lumpectomy, partial mastectomy)
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

Primary outcomes:
measure: Feasibility of the research study as measured by retention rate
timeFrame: 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:
measure: Patient Satisfaction
timeFrame: 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).)
measure: Anxiety
timeFrame: 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).)
measure: Health-related quality of life
timeFrame: 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).)
measure: Feasibility measure: Recruitment rate
timeFrame: 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.
measure: Feasibility measure: Compliance rate
timeFrame: 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.
measure: Feasibility measure: Percent of patients who meet eligibility criteria
timeFrame: 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.
measure: Feasibility measure: Time assessment
timeFrame: 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.
measure: Feasibility measure: Budget assessment
timeFrame: 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.
measure: Feasibility measure: Personnel time
timeFrame: 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.
measure: Feasibility measure: Treatment effect size and variance of the primary, secondary outcome.
timeFrame: 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.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Sophocles Voineskos, MD, MSc.
role: PRINCIPAL_INVESTIGATOR
References: