Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction. (PROM-Q)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Surgery; Patient Satisfaction; Breast Disease
• Intervention / Treatment: Procedure: Pre- or sub-pectoral implant based immediate breast reconstruction

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Baek Kim, FRCS MD MA; Phone Number: 0113 2068724; Email: b.kim@nhs.net
• Study Contact Backup: Name: Sue Hartup, RGN BSc PGC; Phone Number: 0113 2068628

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Recruiting
      • Leeds Teaching Hospitals NHS Trust
      • Contact: Baek Kim, FRCS MD MA; Phone Number: 01132068724; Email: B.Kim@nhs.net
      • Principal Investigator: Baek Kim, FRCS MD MA
      • Sub-Investigator: Shireen Mckenzie, FRCS(Ed) MD
      • Sub-Investigator: Sue Hartup, RGN BSc PGC
      • Sub-Investigator: Stacey Jones, MRCS(Ed) MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Male or transgender
• Mastectomy only with no reconstruction
• Delayed reconstruction
• Autologous reconstruction
• Cognitive impairment or inability to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing implant based immediate breast reconstruction.; Patients will undergo either pre- or sub-pectoral implant based immediate breast reconstruction.

Procedure: Pre- or sub-pectoral implant based immediate breast reconstruction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months post-surgery

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Baek Kim, FRCS MD MA, Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Breast reconstruction; Breast implant; Patient reported outcome measures
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: IRAS 283017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No