QUEST Trial A - Quality of life following mastectomy and breast reconstruction

ISRCTN	ISRCTN38846532
DOI	https://doi.org/10.1186/ISRCTN38846532
Secondary identifying numbers	CRUK/08/027

Submission date: 15/12/2009
Registration date: 06/01/2010
Last edited: 04/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-how-women-feel-about-themselves-after-breast-reconstruction-during-surgery-breast-cancer-quest-a

Contact information

Dr Zoe Winters
Scientific

Bristol Royal Infirmary
Clinical Sciences
South Bristol
Level 7, Marlborough Street
Bristol
BR2 8HW
United Kingdom

Phone	+44 (0)117 928 2365
Email	zoe.winters@bristol.ac.uk

Study information

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multicentre randomised trial to assess the impact of the type of breast reconstruction on quality of life following mastectomy
Study 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
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

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	55
Total final enrolment	17
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 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

University Hospitals of Bristol NHS Foundation Trust (UK)
Hospital/treatment centre

Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
England
United Kingdom

Website	http://www.uhbristol.nhs.uk/
"ROR"	https://ror.org/04nm1cv11

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

BUPA Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Location: United Kingdom

University Hospitals of Bristol NHS Foundation Trust (UK) - Above and Beyond Charities

No information available

Allergan Aesthetics (UK)

No information available

Royal College of Surgeons of England (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): RCS
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	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

Editorial Notes

04/04/2022: Plain English results and total final enrolment added.
21/02/2018: Publication reference added.