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

ISRCTN	ISRCTN92581226
DOI	https://doi.org/10.1186/ISRCTN92581226
Secondary identifying numbers	CRUK/08/027

Submission date: 15/12/2009
Registration date: 06/01/2010
Last edited: 26/10/2022

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-comparing-how-women-feel-about-themselves-after-having-immediate-or-delayed-breast-reconstruction-surgery-quest-b

Contact information

Dr Zoe Winters
Scientific

Bristol Royal Infirmary
Clinical Sciences
South Bristol
Level 7, Marlborough Street
Bristol
BS2 8HW
United Kingdom

Study information

Study design	Phase III multicentre parallel randomised feasibility trial
Primary study design	Interventional
Secondary study design	Randomised controlled 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 timing of breast reconstruction on quality of life following mastectomy
Study acronym	QUEST Trial B
Study hypothesis	1. 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 2. To evaluate Health Related Quality of Life (HRQL) As of 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 on 11/09/2010 (ref: 10/H0206/42)
Condition	Breast cancer
Intervention	Group 1: immediate autologous extended tissue based LDBR (immediate autologous extended lattissimus dorsi [ALD]) Group 2: staged-delayed autologous extended tissue based LDBR (delayed ALD). The group allocated to immediate reconstruction will have one surgical intervention at the time of mastectomy. The patients in the stage-delayed group will have a two stage reconstruction. The first stage is carried out at the time of mastectomy and the second surgical intervention will be delayed until 6 months post-mastectomy in patients receiving radiotherapy alone and approx 12 months post-mastectomy in patients receiving both chemo- and radiotherapy. 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 change from baselines to each of the follow-up assessments at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months between allocated treatment groups
Overall study start date	07/07/2011
Overall study end date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	55
Participant inclusion criteria	1. 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. Technically suitable for a stage delayed autologous extended tissue-based latissimus dorsi (LD) procedure (this includes patients agreeable to a Wise or central reduction pattern reconstruction and a planned contralateral symmetrisation procedure if there is not sufficient volume to reconstruct the breast to its native size) 3. Pre-operative evaluation of the breast and axilla suggest that post-operative radiotherapy (RT) is anticipated according to local RT policy 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 report 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. Loco-regional recurrence 5. Previous wide local excision requiring completion mastectomy 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 magnetic resonance imaging (MRI) 8. Previous malignancy except basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin 9. Significant other clinical risk factors and co-morbidities e.g. body mass index (BMI), diabetes, smoker according to local policy
Recruitment start date	09/07/2011
Recruitment end date	14/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bristol Royal Infirmary

Bristol
BS2 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
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link added.