ANTHEM A study to determine the feasibility of undertaking a large scale study comparing the clinical and patient-reported outcomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction (ANTHEM Feasibility Study).
Overview:
Breast-conserving surgery (BCS) is the preferred treatment for many women with breast cancer. However, standard techniques frequently result in poor cosmetic outcomes and mastectomy (removal of the breast) with or without immediate breast reconstruction is often recommended. Currently, 40% of the 55,000 women diagnosed with breast cancer each year undergo a mastectomy but of these only 1 in 4 receive reconstruction. Oncoplastic breast conservation surgery (OPBCS) describes a range of volume replacement (e.g. local perforator flap [LPF]) and volume displacement techniques (e.g. therapeutic mammaplasty (TM)) that may extend the boundaries of standard BCS and allow some women to avoid mastectomy and potentially improve their quality of life.
There is a need for high-quality research to determine whether OPBCS offers a safe and effective alternative to mastectomy but preliminary work is needed to ensure a future large-scale study is feasible, well-designed and addresses questions important to patients and the NHS. The overall aim of this study is to assess the feasibility of undertaking a large-scale multicentre prospective cohort study to compare the clinical and cost-effectiveness of OPBCS as a safe and effective alternative to mastectomy with and without immediate breast reconstruction (IBR), and to determine the most appropriate outcome measures for use in the main study.
Aims:
The overall aim of the ANTHEM feasibility study is to assess the feasibility of undertaking a large-scale multicentre prospective cohort study to compare the clinical and cost-effectiveness of oncoplastic breast conserving surgery (OPBCS) as a safe and effective alternative to mastectomy with and without (+/-) immediate breast reconstruction (IBR) and to determine the most appropriate outcome measures for use in the main study. In addition to explore women’s decision making for different surgical procedures, rationale for choice and perceptions of outcome.
Specific objectives:
- Centres and surgeons
i. To describe the provision of OPBCS in breast and plastic surgical units across the UK and the numbers of surgeons currently offering patients OPBCS (volume displacement (therapeutic mammaplasty [TM]) and replacement (local perforator flaps, [LPF] techniques) as an alternative to mastectomy (to identify surgeons who will be willing and able to participate in a future study)
ii. To estimate the approximate numbers of OPBCS (TM and LPF) procedures offered to patients who would otherwise require a mastectomy at local centres across the UK (to inform the feasibility of a future large-scale study)
iii. To explore variations in the indications and contraindications for different approaches to OPBCS (TM and LPF) and immediate breast reconstruction (implant-based; pedicled and free-flaps) across the UK in particular what patient (e.g. age, body mass index, smoking), tumour (e.g. size; multifocality) and treatment (neoadjuvant therapy; need for post-mastectomy radiotherapy) factors influence decision making (to estimate the potential magnitude of benefit of OPBCS in the mastectomy population i.e. portion of patients eligible for OPBCS who would not be suitable for immediate breast reconstruction)
iv. To explore how OPBCS procedures are coded to inform the feasibility of undertaking data linkage in the future study
v. To consolidate the breast and plastic surgical research network established during the TeaM and iBRA-2 national audits to optimise the delivery of the future study
- Participants and pathways
i. To determine the proportion of patients offered OPBCS as an alternative to mastectomy at participating sites and types of OPBCS offered.
ii. To explore what proportion of patients suitable for OPBCS elect to undergo the procedure and what proportion choose to undergo mastectomy +/- IBR and the reasons for this
iii. To determine the proportion of patients undergoing OPBCS in whom mastectomy is avoided and outcomes for patients in whom it is not
iv. To explore patients’ views of OPBCS and mastectomy +/- IBR to understand decision-making for surgery and potential barriers to informed choice
v. To explore variations in the patient pathway (e.g. use of neoadjuvant treatment; day-case vs inpatient procedures; simultaneous vs delayed contralateral symmetrisation) to inform optimal timing of outcome assessments in the main study
- Outcome and measures
i. To determine whether existing tools (breast cancer core domains of the BREAST-Q) are valid in the OPBCS population and whether these subscales are directly comparable across patient groups.
ii. To explore whether subscales of the BREAST-Q measure key outcome domains using triangulation with established measures of normality (ICECAP-A) and quality of life (EQ-5D-5L).
iii. To use qualitative interviews to explore whether the BREAST-Q subscales reflect key core outcome domains (satisfaction with breasts; emotional well-being and physical well-being); whether they are adequate and whether the individual items are acceptable to patients.
iv. To generate comparative clinical and patient-reported outcome data to inform sample size calculations for the main study
v. To explore the feasibility of collecting electronic PROMs in the main study
vi. To explore the feasibility of using a novel ‘targeted micro-costing’ approach based on patient pathway mapping to collect resource use data on different procedures at multiple sites in the main trial
- Patient and public involvement
i. To establish a PPI group
ii. To inform proposed study design, selection of outcome measures, timing of outcome assessment
Participant inclusion criteria:
- Female patients over 18 years of age
- Invasive breast cancer or ductal carcinoma in situ (DCIS) not considered suitable for standard BCS or simple level 1 techniques
- Assessed by the breast cancer (and oncoplastic, if applicable) multidisciplinary team (MDT) and the operating surgeon as being suitable candidates for either OPBCS (either TM or LPF) as an alternative to a mastectomy OR mastectomy with or without an immediate breast reconstruction (using any technique) and offered both OPBCS and mastectomy options
- No restrictions will be placed on the size of the tumour as decisions on the suitability of a patient for simple BCS will be based on assessments of the size of the tumour relative to the overall size of the breast and its position within the breast rather than on explicit size criteria
Participant exclusion criteria:
- Women offered OPBCS for reasons other than to avoid mastectomy (e.g. quality of life if large breasted)
- Women offered standard BCS or level 1 procedures only
- Women not able or willing to give informed consent
Planned sample size:
250 patients
Total number of sites planned:
20 to 30
Timeline:
Due to the extension of the patient recruitment end date until 31/12/22, we have extended the study end date to take into account the 12 month follow up period required for the study. The new study end date will, therefore, be 31st March 2024.
Contact information:
Dr Charlotte Davies (ANTHEM Study Manager and Senior Research Associate, University of Bristol)
E-mail: ANTHEM-Study@bristol.ac.uk
Tel: 0117 9287209 or study mobile 07816 370966