Condition category
Cancer
Date applied
20/01/2016
Date assigned
04/02/2016
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Shelley Potter

ORCID ID

Contact details

Room 3.12 Canynge Hall
School of Social and Community Medicine
University of Bristol
Bristol
BS8 2PS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The iBRA (implant Breast Reconstruction evAluation) Study - a prospective multicentre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant breast reconstuction

Acronym

The iBRA (implant Breast Reconstruction evAluation) Study

Study hypothesis

Implant-based breast reconstruction (IBBR) is the most commonly-performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionalised the procedure, but there is a lack of high-quality outcome data to support the safety or efficacy of these techniques. Randomised clinical trials (RCTs) are the best way of comparing treatments but surgical RCTs are challenging. The iBRA (implant Breast Reconstruction evAluation) study aims to inform the feasibility, design and conduct of a pragmatic-RCT to examine the effectiveness of new approaches to IBBR.

Ethics approval

Phases 1 & 2 do not require ethical approval because they involve the routine collection of clinical and patient reported outcome data as recommended by the 'Oncoplastic Surgery. Guidelines for Good Practice'. This has been agreed with the host organisations. Ethical approval will be obtained for Phase 3, the randomisation acceptability survey as this does constitute research. The University of Bristol will act as the sponsor and proportional ethics review will be obtained prior to commencing this phase of the study.

Study design

Multi-centre prospective observational cohort study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Implant-based breast reconstruction following mastectomy for breast cancer or risk reduction

Intervention

Phase 1 – A national practice questionnaire (NPQ)

The aim of phase 1 is to understand the current practice of implant-based breast reconstruction in the UK to inform the design of a definitive RCT. Specific objectives of phase 1 are:
1. To establish the number of centres and surgeons able and willing to participate in a future trial.
2. To determine the incidence of each type of IBBR being performed at centre and surgeon level (informing trial design and sample size)
3. To examine how surgeons select suitable patients for surgery (informing the inclusion criteria)
4. To determine how the implant procedures are performed at centre level, especially how lower-pole coverage is achieved (informing trial design)
5. To establish current practice of pre and post-surgical care in IBBR which will inform the use and standardisation of concomitant interventions in the trial
6. To engage surgeons to develop an appreciation of the need for RCTs in IBBR

Phase 2 – A prospective cohort study of patients undergoing implant-based breast reconstruction

The aim of Phase 2 is to understand the practice and outcomes of IBBR in the UK to inform the design of a definitive RCT. Specific objectives of phase 2 are:
1. To determine how implant procedures are carried out at centre level, especially how lower-pole coverage is achieved (informing trial design)
2. To evaluate the practicality of obtaining clinical and patient-reported outcome data and the feasibility of trainees recruiting patients and collecting longitudinal data, with a view to using this approach in a future trial
3. To determine the outcomes of different approaches to IBBR. Including identifying risk factors for adverse outcomes such as the impact of the learning curve (informing entry criteria, primary and secondary outcomes and parameters required for a power calculation).
4. To explore the ability of the BREAST-Q to discriminate between procedure-subtypes and hence its value for use in a future trial
5. To engage and educate consultants and trainees to establish an appreciation of the need for, and a desire to participate in, a future trial in IBBR

Centres identified as performing immediate IBBR from the NPQ (Phase 1) will be eligible to progress to Phase 2, the prospective cohort study. The named supervising consultant will act as the principal investigator for each unit and trainee leads will be responsible for recruitment and data collection.

The study will be piloted in two centres (Liverpool and Bristol) prior to national roll-out to evaluate feasibility and effectiveness of trainee involvement in recruitment and data collection. Methods of data management will also be assessed.

Potential participants will be identified prospectively by the local study team via clinics, local MDTs, consultant surgeons and clinical nurse specialists. Simple demographic, procedure and process data will be collected for each participant. Data will be recorded in an anonymised format using a unique alphanumeric study identification number on a secure web-based database. In-hospital complication data will be collected prospectively by trainee leads. Patients will be reviewed in clinic at 30 days to collect complication and oncology data. Note-review will be performed in patients who do not attend for 30 day follow-up.

Trainees or a locally-designated member of team will approach patients in clinic or during their admission to obtain consent for PROMs assessment. Individual centres will be free to determine the optimal approach for recruiting patients to this part of the study. PROMs assessment will be by post or e-mail, dependent on patient preference, at 3 and 18-months (for those eligible for long-term assessment) following surgery and will evaluate satisfaction with care, complications and health-related quality of life (BREAST-Q). If consent is obtained, contact details will be sent securely to the co-ordinating centre and questionnaires distributed centrally to optimise compliance, allow accurate follow-up and reduce the incidence of missing data.

Phase 3– An IBBR-RCT acceptability-survey to explore patients’ and surgeons’ views of proposed trial designs.

The aim of Phase 3 is to investigate the acceptability to patients and surgeons of candidate trial designs generated from phases 1 and 2 to determine a suitable design to progress to a definitive, pragmatic trial. Specific objectives of phase 3 are:
1. To determine the proportion of patients and surgeons willing and able to participate in each candidate study design
2. To determine patients’ and surgeons’ views regarding the most appropriate primary outcome for the definitive trial
3. To determine the degree of pragmatism (e.g. product selection; technique; variation in pre/peri/post-operative care) that would be acceptable and feasible to surgeons in the definitive trial
4. To explore barriers and facilitators to potential participation in an RCT in IBBR and how these challenges may be overcome

Using phase 1 and 2 data, two RCT acceptability surveys (RCTAS) (one each for patients and surgeons) will be developed by members of the steering group. Respondents will communicate their willingness to participate in different candidate trials; give opinions regarding primary outcomes and surgeons will offer views about the degree of pragmatism that would be acceptable in a future trial.

A qualitative research component will be integrated into Phase 3 of the study to provide an in-depth exploration of the acceptability of proposed trial designs and expand on findings from the questionnaire survey. Respondents to the questionnaire who are willing to be contacted will be purposively sampled and interviewed to explore common and unusual questionnaire responses to enable a more detailed understanding of the acceptability of proposed study designs. Patients and surgeons will be interviewed (with the final number depending on data saturation) using a flexible topic guide to investigate their views on willingness to participate in the proposed study designs, appropriate outcome measures and, for surgeons, the degree of pragmatism that would be acceptable and feasible in the definitive trial

Phase 4 - Design of the definitive RCT

The feasibility, design and conduct of a definitive RCT will be determined by the outcomes of phases 1-3

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

The feasibility study will determine the most appropriate study design. The primary outcome will be identified and outcome data used to inform a sample size calculation. Information from rates of surgery and patient selection criteria will be combined with estimates of surgeon and centre willingness to participate in a trial to assess the feasibility of undertaking a definitive trial that would achieve target recruitment within 3 years.
The following specific progression criteria will be reviewed at 30 months:
1. At least 40% of surgeons and patients responding to the RCT-Acceptability Survey can agree to participate in an RCT in implant-based breast reconstruction surgery
2. The cohort study data and findings of the RCT-Acceptability Surveys (for patients and surgeons) and qualitative work provide sufficient information to inform the selection of an acceptable and appropriate primary outcome measure to inform the sample size required for main study.
3. Based on the sample size calculation for the chosen primary outcome, the number of centres willing to participate, the anticipated patient consent rate, and data from the incident numbers of patients that are likely to be eligible to participate in a RCT, including information about reconstructive techniques used and to be compared in the trial, the study will be practical and achievable with three years of recruitment. Data from an analysis of NIHR portfolio data (Kaur, MRC North West Hub for Trials Methodology Research, personal communication) shows that the trials recruiting to time and target did so with a median recruitment period of 13 months, interquartile range 8 to 24. 42/45 (93%) recruited successfully within three years. Although these data are for paediatric trials, there is no obvious reason why the results would not be generalisable to recruitment in adult studies.
4. Data from the surveys show that a sufficient number of centres, each with a minimum of 2 participating surgeons are willing and able to participate in the main trial.
5. Feasibility of using the trainee collaborative model to recruit patients and follow them up with <10% missing data over all the specified time points.

Secondary outcome measures

Optimal design and conduct of the RCT

Overall trial start date

25/11/2013

Overall trial end date

30/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients
2. Undergoing immediate IBBR for malignancy or risk-reduction under the care of the breast or plastic surgeons

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

This feasibility study aims to estimate parameters required for an RCT sample size calculation although the primary outcome most suitable is not yet known. Parameters include estimating the standard deviations for each candidate outcome listed below from which, as a result of this study, the most important outcome will be determined and used as the primary outcome when progressing to an RCT.

Participant exclusion criteria

1. Women undergoing delayed breast reconstruction
2. Revisional surgery
3. Patients not willing or able to provide informed consent for the patient reported outcomes part of the study

Recruitment start date

04/02/2014

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool University Hospital
L7 8XP
United Kingdom

Trial participating centre

Nottingham Breast Institute
NG5 1PB
United Kingdom

Trial participating centre

New Cross Hospital Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Royal Marsden Hospital
SW3 6JJ
United Kingdom

Trial participating centre

University Hospitals South Manchester
M23 9LT
United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
BN1 6AG
United Kingdom

Trial participating centre

East Lancashire NHS Trust
BB10 2PQ .
United Kingdom

Trial participating centre

Arrowe Park Hospital - Wirral University Teaching Hospital NHS Trust
CH49 5PE
United Kingdom

Trial participating centre

Barts Health NHS Trust
E1 2AD
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
LS9 7LN
United Kingdom

Trial participating centre

Belfast Health and Social Care Trust
BT9 7AB
United Kingdom

Trial participating centre

Worcester Acute NHS Trust
WR5 1DD
United Kingdom

Trial participating centre

The Newcastle on Tyne Hospitals NHS Foundation Trust
NE1 4LP
United Kingdom

Trial participating centre

Frimley Health NHS Foundation Trust
GU16 7UJ
United Kingdom

Trial participating centre

Bolton NHS Foundation Trust
BL4 0JR
United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
EX2 7JU
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire
CV2 2DX
United Kingdom

Trial participating centre

West Hertfordshire Hospitals NHS Trust
HP2 4AD
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
S10 2JF
United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Trust
LE3 9QP
United Kingdom

Trial participating centre

Airedale NHS Foundation Trust
BD20 6TD
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
B15 2WB
United Kingdom

Trial participating centre

Blackpool Teaching Hospitals NHS Foundation Trust
FY3 8NR
United Kingdom

Trial participating centre

Homerton University Hospitals NHS Foundation Trust
E9 6SR
United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
BD9 6RJ
United Kingdom

Trial participating centre

Luton and Dunstable University Hospital
LU4 0DZ
United Kingdom

Trial participating centre

Dorset County Hospital NHS Foundation Trust
DT1 2JY
United Kingdom

Trial participating centre

North Bristol NHS Trust
BS10 5NB
United Kingdom

Trial participating centre

Milton Keynes University Hospital NHS Foundation Trust
MK6 5LD
United Kingdom

Trial participating centre

Musgrove Park Hospital
TA1 5DA
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
RG1 5AN
United Kingdom

Trial participating centre

Royal Surrey County NHS Foundation Trust
GU2 7XX
United Kingdom

Trial participating centre

Northern Lincolnshire and Goole NHS Foundation Trust
DN15 7BH
United Kingdom

Trial participating centre

York Teaching Hospital NHS Foundation Trust
YO31 8HE
United Kingdom

Trial participating centre

Peterborough and Stamford Hospitals NHS Foundation Trust
PE3 9GZ
United Kingdom

Trial participating centre

Royal United Hospital NHS Foundation Trust
BA1 3NG
United Kingdom

Trial participating centre

Aneurin Bevan University Health Board
NP7 7EG
United Kingdom

Trial participating centre

Countess of Chester NHS Foundation Trust
CH2 1UL
United Kingdom

Trial participating centre

University Hospitals North Stafford
ST4 6QG
United Kingdom

Trial participating centre

Great Western Hospitals NHS Foundation Trust
SN3 6BB
United Kingdom

Trial participating centre

St Helens and Knowsley Teaching Hospitals NHS Trust
L35 5DR
United Kingdom

Trial participating centre

Portsmouth Hospitals NHS Trust
PO6 3LY
United Kingdom

Trial participating centre

University Hospitals Durham
DH1 5TW
United Kingdom

Trial participating centre

Royal Hampshire County Hospital
SO22 5DG
United Kingdom

Trial participating centre

Hull and East Yorkshire Hospitals NHS Trust
HU16 5JQ
United Kingdom

Trial participating centre

Cardiff and Vale University Health Board
CF64 2XX
United Kingdom

Trial participating centre

Barnsley Hospital NHS Foundation Trust
S75 2EP
United Kingdom

Trial participating centre

Poole Hospital NHS Foundation Trust
BH15 2JB
United Kingdom

Trial participating centre

Ashford and St Peter's Hospitals NHS Foundation Trust
KT16 0PZ
United Kingdom

Trial participating centre

Chesterfield Royal Hospital -NHS Foundation Trust
S44 5BL
United Kingdom

Trial participating centre

Warrington and Halton Hospitals NHS Foundation Trust
WA5 1QG
United Kingdom

Trial participating centre

Southern Health and Social Care Trust
BT63 5QQ
United Kingdom

Trial participating centre

University College Hospitals London
NW1 2BU
United Kingdom

Trial participating centre

South Warwickshire NHS Foundation Trust
CV34 5BW
United Kingdom

Trial participating centre

University Hospital Southampton NHS Foundation Trust
SO16 6YD
United Kingdom

Trial participating centre

Kettering General Hospital NHS Foundation Trust
NN16 8UZ
United Kingdom

Trial participating centre

Yeovil District Hospital NHS Foundation Trust
BA21 4AT
United Kingdom

Trial participating centre

Salisbury NHS Foundation Trust
SP2 8BJ
United Kingdom

Trial participating centre

Torbay and South Devon NHS Foundation Trust
TQ2 7AA
United Kingdom

Trial participating centre

Isle of Wight NHS Trust
PO30 5TG
United Kingdom

Trial participating centre

St Georges London
SW17 0QT
United Kingdom

Sponsor information

Organisation

University of Bristol (phase 3 only)

Sponsor details

Senate House
Tyndall Ave
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

www.bristol.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Association of Breast Surgery (pump-priming)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Association of Plastic Aesthetic and Reconstructive Surgeons (pump-priming)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Several approaches will be used to disseminate the results of this study. A full report will be written for RfPB at regular intervals and the final report will be written in the last 3 months of the project
Publications
2. The work will be published in international peer-reviewed journals relevant to surgical oncologists, breast and plastic surgeons such as the Annals of Surgical Oncology, Plastic and Reconstructive Surgery and the British Journal of Surgery.
3. Oral and poster presentations at conferences
4. It will be submitted for presentation at national and international meetings (ABS, BAPRAS, ORBS) and at the Association of Surgeons in Training Conference and the National Oncoplastic Fellowship meetings to engender support for a trial among the next generation of consultant surgeons

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/07/2016: Internal review.