Breast DiseasePROM-QNCT04842240
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
An observational study of Breast Disease and Breast Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR). This is the commonest form of breast reconstruction and current advances in surgical technology have led to increasing number of patients having implants… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Disease, Breast Cancer, Patient Satisfaction
- What is being tested?
- Pre- or sub-pectoral implant based immediate breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2019to Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing mastectomy who opt to have immediate implant based reconstruction. This will be either patients undergoing breast cancer treatment or counselled with regards to risk reducing strategies for known germline breast cancer susceptibility gene mutations or at increased risk due to family history. The study will be carried out at a single teaching hospital breast unit.
Who may be able to join
- Skin or nipple sparing mastectomy with immediate implant based reconstruction for breast cancer or for risk reduction
- Unilateral or bilateral mastectomy
- Implant or expander based immediate reconstruction
- Able to read and understand questionnaire in English
Who cannot join
- Male or transgender
- Mastectomy only with no reconstruction
- Delayed reconstruction
- Autologous reconstruction
- Cognitive impairment or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Sue Hartup, RGN BSc PGC contact
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
Baek Kim, FRCS MD MA, 01132068724, B.Kim@nhs.net
Baek Kim, FRCS MD MA
About this study
Official title: Comparison of Patient Reported Outcome Measures in Patients Undergoing Pre Versus Sub-pectoral Implant Based Breast Reconstruction
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR). This is the commonest form of breast reconstruction and current advances in surgical technology have led to increasing number of patients having implants placed above the pectoral muscle (pre-pectoral), rather than below it (sub-pectoral). This has important benefits for patients including shorter surgery time, quicker recovery, and avoidance of animation deformity (visible muscle twitching of the reconstructed breast) as the pectoral muscle is not divided to cover the implant. However, potential disadvantages include rippling effect as the implant is covered by the skin and subcutaneous tissue only, as well as potentially higher risk of capsule (scar tissue) formation.
By utilising a validated questionnaire (BREAST-Q), we will assess for any difference in PROMs between the two groups of patients. The results will provide valuable information for future patients when making an informed decision about their reconstruction options. This questionnaire study will include consecutive patients undergoing mastectomy and immediate IBR for breast cancer as well as for risk reduction at Leeds Teaching Hospitals NHS Trust. The study participants will undergo either pre- or sub-pectoral IBR based on their informed discussion with the clinical team. This is a non-randomised observational study.
Read the detailed description
Patients who undergo implant based immediate breast reconstruction (IBR) are offered an option of pre- versus sub-pectoral breast reconstruction. Both approaches are well established and have proven safety in terms of low rate of complication rates. However, we do not know if there is a significant difference in patient reported outcome measures (PROMs) between the two surgical techniques over time.
The study aims to investigate if the difference in the surgical technique for immediate implant breast reconstruction (pre- versus sub-pectoral) influences patient perceived outcomes. This is a prospective non-randomised longitudinal cohort study which will aim to recruit consecutive eligible patients undergoing mastectomy with immediate implant based reconstruction surgery for early breast cancer or risk reduction using repeated measures and mixed methods.
This study will utilise a well validated patient questionnaire for breast reconstruction (BREAST-Q; http://qportfolio.org/breast-q/breast-cancer/) and will be carried out at a teaching hospital breast unit. The specific objectives will be to compare aesthetic outcome, post-operative pain and functionality as reported by PROMs. The study participants will be followed up for 12 months. The PROMs data will be collected at baseline, 2 weeks, as well as at 3 and 12 months post-surgery. Matching data will be collected for each study participant including the type of surgery performed, patient characteristics, post-operative complications, and any recommended adjuvant treatment. These data will be correlated with the matching questionnaire results in order to explore for potential clinical factors which may influence PROMs.
- Conditions
- Breast Disease, Breast Cancer, Patient Satisfaction, Surgery
- Being tested
- Pre- or sub-pectoral implant based immediate breast reconstruction
- Keywords
- Breast reconstruction, Breast implant, Patient reported outcome measures
- Medical subject headings
- Breast Diseases, Breast Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre- or sub-pectoral implant based immediate breast reconstructionProcedure or surgery
All study participants will undergo skin sparing mastectomy (with or without nipple preservation) for breast cancer or for risk reduction. Patients will undergo immediate breast reconstruction using an implant or a tissue expander. The device will be placed in pre- or sub-pectoral plane which will be supported by mesh (Tiloop/Surgimend Acellular Dermal Matrix) and/or a dermal flap.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing implant based immediate breast reconstruction. | Patients will undergo either pre- or sub-pectoral implant based immediate breast reconstruction. Receives: Procedure: Pre- or sub-pectoral implant based immediate breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare any difference in patient reported outcome measures in patients undergoing pre- versus sub-pectoral implant based breast reconstruction.
To measure the difference in BREAST-Q score in patients undergoing pre- versus sub-pectoral implant based breast reconstruction. We will compare psychosocial well-being, satisfaction with breasts, physical well-being, animation deformity, and patient experience with the clinical team.
Measured: Up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Sep 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baek Kim, FRCS MD MA, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842240
- Sponsor's protocol ID
- IRAS 283017
- Acronym
- PROM-Q
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rampal R, Jones SJ, Hartup S, Robertson C, Tahir W, Jones SL, McKenzie S, Savage JA, Kim B. Three and twelve-month analysis of the PROM-Q study: comparison of patient-reported outcome measures using the BREAST-Q questionnaire in pre- vs. sub-pectoral implant-based immediate breast reconstruction. Breast Cancer Res Treat. 2024 Nov;208(2):275-282. doi: 10.1007/s10549-024-07416-5. Epub 2024 Jul 10.
PubMed 38985220
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Reported Outcome Measures in Patients Undergoing Pre Versus Sub-pectoral Implant Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04842240
- Acronym / sponsor ID
- PROM-Q / IRAS 283017
- Conditions
- Breast Disease, Breast Cancer, Patient Satisfaction, Surgery
- Keywords
- Breast reconstruction, Breast implant, Patient reported outcome measures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Apr 2021 (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.
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR). This is the commonest form of breast reconstruction and current advances in surgical technology have led to increasing number of patients having implants placed above the pectoral muscle (pre-pectoral), rather than below it (sub-pectoral). This has important benefits for patients including shorter surgery time, quicker recovery, and avoidance of animation deformity (visible muscle twitching of the reconstructed breast) as the pectoral muscle is not divided to cover the implant. However, potential disadvantages include rippling effect as the implant is covered by the skin and subcutaneous tissue only, as well as potentially higher risk of capsule (scar tissue) formation.
By utilising a validated questionnaire (BREAST-Q), we will assess for any difference in PROMs between the two groups of patients. The results will provide valuable information for future patients when making an informed decision about their reconstruction options. This questionnaire study will include consecutive patients undergoing mastectomy and immediate IBR for breast cancer as well as for risk reduction at Leeds Teaching Hospitals NHS Trust. The study participants will undergo either pre- or sub-pectoral IBR based on their informed discussion with the clinical team. This is a non-randomised observational study.
Detailed description
Patients who undergo implant based immediate breast reconstruction (IBR) are offered an option of pre- versus sub-pectoral breast reconstruction. Both approaches are well established and have proven safety in terms of low rate of complication rates. However, we do not know if there is a significant difference in patient reported outcome measures (PROMs) between the two surgical techniques over time.
The study aims to investigate if the difference in the surgical technique for immediate implant breast reconstruction (pre- versus sub-pectoral) influences patient perceived outcomes. This is a prospective non-randomised longitudinal cohort study which will aim to recruit consecutive eligible patients undergoing mastectomy with immediate implant based reconstruction surgery for early breast cancer or risk reduction using repeated measures and mixed methods.
This study will utilise a well validated patient questionnaire for breast reconstruction (BREAST-Q; http://qportfolio.org/breast-q/breast-cancer/) and will be carried out at a teaching hospital breast unit. The specific objectives will be to compare aesthetic outcome, post-operative pain and functionality as reported by PROMs. The study participants will be followed up for 12 months. The PROMs data will be collected at baseline, 2 weeks, as well as at 3 and 12 months post-surgery. Matching data will be collected for each study participant including the type of surgery performed, patient characteristics, post-operative complications, and any recommended adjuvant treatment. These data will be correlated with the matching questionnaire results in order to explore for potential clinical factors which may influence PROMs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing implant based immediate breast reconstruction. | – | Procedure: Pre- or sub-pectoral implant based immediate breast reconstructionPatients will undergo either pre- or sub-pectoral implant based immediate breast reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing mastectomy who opt to have immediate implant based reconstruction. This will be either patients undergoing breast cancer treatment or counselled with regards to risk reducing strategies for known germline breast cancer susceptibility gene mutations or at increased risk due to family history. The study will be carried out at a single teaching hospital breast unit.
Key inclusion criteria (4 listed)
- Skin or nipple sparing mastectomy with immediate implant based reconstruction for breast cancer or for risk reduction
- Unilateral or bilateral mastectomy
- Implant or expander based immediate reconstruction
- Able to read and understand questionnaire in English
Key exclusion criteria (5 listed)
- Male or transgender
- Mastectomy only with no reconstruction
- Delayed reconstruction
- Autologous reconstruction
- Cognitive impairment or inability to provide informed consent
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 |
|---|---|---|
| Pre- or sub-pectoral implant based immediate breast reconstructionAll study participants will undergo skin sparing mastectomy (with or without nipple preservation) for breast cancer or for risk reduction. Patients will undergo immediate breast reconstruction using an implant or a tissue expander. The device will be placed in pre- or sub-pectoral plane which will be supported by mesh (Tiloop/Surgimend Acellular Dermal Matrix) and/or a dermal flap. | Procedure or surgery | Patients undergoing implant based immediate breast reconstruction. |
Primary outcome
To compare any difference in patient reported outcome measures in patients undergoing pre- versus sub-pectoral implant based breast reconstruction.
Time frame: Up to 12 months post-surgery
To measure the difference in BREAST-Q score in patients undergoing pre- versus sub-pectoral implant based breast reconstruction. We will compare psychosocial well-being, satisfaction with breasts, physical well-being, animation deformity, and patient experience with the clinical team.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 38985220Rampal R, Jones SJ, Hartup S, Robertson C, Tahir W, Jones SL, McKenzie S, Savage JA, Kim B. Three and twelve-month analysis of the PROM-Q study: comparison of patient-reported outcome measures using the BREAST-Q questionnaire in pre- vs. sub-pectoral implant-based immediate breast reconstruction. Breast Cancer Res Treat. 2024 Nov;208(2):275-282. doi: 10.1007/s10549-024-07416-5. Epub 2024 Jul 10.
- Individual participant dataSharing planned: No
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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.
Sue Hartup, RGN BSc PGC contact
Baek Kim, FRCS MD MA principal investigator
Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Disease and Breast Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baek Kim, FRCS MD MA (0113 2068724, b.kim@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare any difference in patient reported outcome measures in patients undergoing pre- versus sub-pectoral implant based breast reconstruction. (time frame: Up to 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04842240, which also lists 1 linked publication.
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 13 Apr 2021.