Clinical trial NCT04842240: Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
Official title: Comparison of Patient Reported Outcome Measures in Patients Undergoing Pre Versus Sub-pectoral Implant Based Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Disease
Breast Cancer
Patient Satisfaction
Surgery
Keywords: Breast reconstruction
Breast implant
Patient reported outcome measures
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare any difference in patient reported outcome measures in patients undergoing pre- versus sub-pectoral implant based breast reconstruction.
timeFrame: Up to 12 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Baek Kim, FRCS MD MA
role: PRINCIPAL_INVESTIGATOR
References: