Contact information
Type
Scientific
Contact name
Dr Zoe Winters
ORCID ID
Contact details
Bristol Royal Infirmary
Clinical Sciences
South Bristol
Level 7
Marlborough Street
Bristol
BR2 8HW
United Kingdom
+44 (0)117 928 2365
zoe.winters@bristol.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CRUK/08/027
Study information
Scientific title
A multicentre randomised trial to assess the impact of the type of breast reconstruction on quality of life following mastectomy
Acronym
QUEST Trial A
Study hypothesis
To determine the acceptability and experience of randomisation amongst patients and healthcare professionals (surgeons and breast care nurses) and hence the acceptability of a randomised clinical trial in breast reconstruction.
On 21/09/2011 the overall trial start and end dates for this trial have been updated. The previous start date was 30/04/2010 and the previous end date was 31/12/2011.
Ethics approval(s)
South West 2 Research Ethics Committee, 11/09/2010, ref: 10/H0206/41
Study design
Phase III multicentre parallel randomised feasibility trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Patients will be allocated in a 1:1 ratio to either immediate autologous extended lattissimus dorsi (ALD) breast reconstruction or immediate implant assisted lattissimus dorsi (LDI) breast reconstruction. Duration of follow-up is 5 years in both groups.
Intervention type
Procedure/Surgery
Primary outcome measure
1. The number of eligible women who accept randomisation and their subsequent treatment allocation
2. The rationale for women declining randomisation as assessed through the Patient Views on QUEST questionnaire (PVQ)
3. The perceptions of surgeons and breast care nurses regarding equipoise evidence relating to cosmetic appearance, complications and quality of life outcomes through Perceptions of Equipoise Evidence and Randomisation Survey (PEERS)
Secondary outcome measures
Health related quality of life outcomes, measured at each of the follow-up assessments at 3, 6, 12, 24, 36, 48 and 60 months between allocated treatment groups
Overall study start date
01/08/2011
Overall study end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Any women requiring a mastectomy and electing to undergo latissimus dorsi breast reconstruction (LDBR) following a diagnosis of invasive primary breast cancer or ductal carcinoma in situ (DCIS)
2. Pre-operative evaluation of the breast and axilla suggest that post-operative radiotherapy is not anticipated according to local radiotherapy (RT) policy
3. Patient is technically suitable for an autologous extended LD procedure or agreeable to a reduction mammoplasty and planned contralateral reduction
4. Patient does not express a preference regarding procedure type
5. The capacity to understand the patient information sheet and ability to provide written informed consent
6. The capacity to understand and complete the self reported Health Related Quality of Life (HRQL) and General Nordic Questionnaire for Psychological and Social Factors at Work (QPS) questionnaires
7. Physical fitness as per the pre-operative evaluations (electrocardiogram [ECG], chest x-ray [CXR], blood biochemistry)
8. Aged between 25 and 75 years
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
55
Total final enrolment
17
Participant exclusion criteria
1. Prophylactic or risk-reducing surgery (i.e. no malignant or pre-malignant pathology such as lobular carcinoma in situ [LCIS])
2. Previous radiotherapy to the breast
3. Bilateral synchronous pathology
4. Previous wide local excision (requiring completion mastectomy)
5. Loco-regional recurrence
6. Pregnancy as confirmed on blood tests or ultrasound examination
7. Evidence of distant metastases as diagnosed by chest X-ray, bone scan, liver ultrasound scan (USS) or computed tomography (CT) chest/abdomen and/or magnetic resonance imaging (MRI)
Recruitment start date
01/08/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Bristol Royal Infirmary
Bristol
BR2 8HW
United Kingdom
Sponsor information
Organisation
University Hospitals of Bristol NHS Foundation Trust (UK)
Sponsor details
Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
BUPA Foundation (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Funder name
University Hospitals of Bristol NHS Foundation Trust (UK) - Above and Beyond Charities
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Allergan Aesthetics (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal College of Surgeons of England (UK)
Alternative name(s)
RCS
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2015 | Yes | No | |
| Results article | results | 02/09/2016 | Yes | No | |
| Plain English results | 04/04/2022 | No | Yes |