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

ISRCTN ISRCTN92581226
DOI https://doi.org/10.1186/ISRCTN92581226
Protocol serial number CRUK/08/027
Sponsor University Hospitals of Bristol NHS Foundation Trust (UK)
Funders Cancer Research UK (CRUK) (UK), BUPA Foundation (UK), University Hospitals of Bristol NHS Foundation Trust (UK) - Above and Beyond Charities, Allergan Aesthetics (UK), Royal College of Surgeons of England (UK)
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 of protocol

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

Primary study designInterventional
Study designPhase III multicentre parallel randomised feasibility trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA multicentre randomised trial to assess the impact of the timing of breast reconstruction on quality of life following mastectomy
Study acronymQUEST Trial B
Study objectives1. 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)
Health condition(s) or problem(s) studiedBreast cancer
InterventionGroup 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 typeProcedure/Surgery
Primary outcome measure(s)

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)

Key secondary outcome measure(s)

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

Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration55
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment09/07/2011
Date of final enrolment14/12/2012

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Plain English results 26/10/2022 No Yes

Editorial Notes

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

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