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

NCT04842240 | Unknown

• 1 other identifier: IRAS 283017
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breast Disease; Breast Cancer; Patient Satisfaction; Surgery

Keywords

Breast reconstruction; Breast implant; Patient reported outcome measures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Pre- or sub-pectoral implant based immediate breast reconstruction PROCEDURE

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.

Patients undergoing implant based immediate breast reconstruction.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 38985220 DERIVED

MeSH Terms

Conditions

Breast Diseases; Breast Neoplasms; Patient Satisfaction

Interventions

Lead

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Site; Neoplasms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Baek Kim, FRCS MD MA

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baek Kim, FRCS MD MA

CONTACT

0113 2068724; b.kim@nhs.net

Sue Hartup, RGN BSc PGC

CONTACT

0113 2068628

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: September 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)