Breast ReconstructionRESTORENCT03743753
Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
A study testing Experimental in people with Breast Reconstruction and Patient Education, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Reconstruction, Patient Education
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 1 May 2019to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Juravinski Hospital
Hamilton, Ontario
St. Joseph's Healthcare
Hamilton, Ontario
About this study
Official title: Preoperative Education Intervention to Improve Patient Satisfaction and Optimize the Patient Experience in Breast Reconstruction: A Pilot, Feasibility Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Breast Reconstruction, Patient Education
- Being tested
- Experimental
- Keywords
- Patient education, Satisfaction, Anxiety, Quality of life, Implant, Autologous, Breast reconstruction, Alloplastic
- Medical subject headings
- Personal Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 will be measured using the BREAST-Q questionnaire. The BREAST-Q is a patient reported outcome measure of patient satisfaction with breast reconstruction.The reconstructive module of the BREAST-Q will be administered. The questionnaire is composed of 10-13 sections depending on whether the participants underwent autologous or alloplastic reconstruction and whether the participant underwent radiation. All questions are answered on 3, 4, or 5 point Likert scales. The answers of each sections are totaled and compared to the equivalent Rasch transformed score. Zero represents the worst possible score and 100 represents the best.
Measured: 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 will be measured using the Spielberger State-Trait Anxiety Inventory (STAI) for adults questionnaire. The STAI is a patient reported outcome that measures situational and trait anxiety. Of the two subscales, the State Anxiety Scale (S-Anxiety) evaluates the current state of anxiety. The Trait Anxiety Scale (T-Anxiety) evaluates relatively stable aspects of "anxiety proneness", including general states of calmness, confidence and security. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point Likert Scale. Scores range from 20 to 80, where higher scores indicate higher anxiety.
Measured: 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 will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS-29) questionnaire. The PROMIS-29 is a generic health-related quality of life survey that assesses 7 domains (physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, satisfaction with participation in social roles) and is designed to measure self-reported physical, mental and social health and wellbeing. The questions are answered on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. In symptom-oriented domains (pain interference, fatigue, sleep disturbance, anxiety and depression) higher scores represent worse symptomatology. In function-oriented domains (physical functioning and social role) higher scores represent better functioning.
Measured: 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 secondary, feasibility outcome is recruitment rate, the number of participants who were enrolled in the study out of the number who were assessed for eligibility, as described as a percentage. A recruitment rate of >70% will indicate that a larger scale study is feasible.
Measured: 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 secondary, feasibility outcome is compliance rate, the percentage of participants who were randomized to the experimental group who completed the intervention.
Measured: 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: Percent of patients who meet eligibility criteria
This secondary, feasibility outcome is eligibility, the percentage of patients who were assessed for eligibility who meet all the eligibility criteria. An eligibility percentage of >80% will indicate that a larger scale study is feasible.
Measured: 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: Time assessment
This secondary, feasibility outcome is a time assessment, the number of months it take to complete the research study.
Measured: 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: Budget assessment
This secondary, feasibility outcome is a budget assessment, the amount of money and the allocation of money that is required to complete the study. This will be compared to the budget designed prior to study commencement.
Measured: 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: Personnel time
This secondary, feasibility outcome is personnel time, the number of hours and the allocation of hours each member of the research time has dedicated to completing this study.
Measured: 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: Treatment effect size and variance of the primary, secondary outcome.
This secondary, feasibility outcome is treatment effect size. This will be calculated using the mean difference between the control and experimental groups of the Satisfaction with Information subscale in the BREAST-Q at the 3 month follow up time. The mean difference will be divided by the pooled standard deviation (variance) to determine the effect size.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 May 2019
- Primary completion1 Jul 2021
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophocles Voineskos, MD, MSc., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743753
- Sponsor's protocol ID
- 4844
- Acronym
- RESTORE
- Status last verified
- Aug 2022
- First submitted
- 7 Nov 2018
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Education Intervention to Improve Patient Satisfaction and Optimize the Patient Experience in Breast Reconstruction: A Pilot, Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03743753
- Acronym / sponsor ID
- RESTORE / 4844
- Conditions
- Breast Reconstruction, Patient Education
- Keywords
- Patient education, Satisfaction, Anxiety, Quality of life, Implant, Autologous, Breast reconstruction, Alloplastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive the current standard educational information from the surgeon along with an information package. |
| Experimental | Experimental | Other: ExperimentalThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalThe 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. | Other | Experimental |
Primary outcome
Feasibility of the research study as measured by retention rate
Time frame: 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.
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.
10 secondary outcomes
Patient Satisfaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: Percent of patients who meet eligibility criteria
Time frame: 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: Time assessment
Time frame: 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: Budget assessment
Time frame: 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: Personnel time
Time frame: 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: Treatment effect size and variance of the primary, secondary outcome.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophocles Voineskos, MD, MSc. principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Breast Reconstruction and Patient Education, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the research study as measured by retention rate (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.