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11 February 2012
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| [ Print-friendly version ] |
| QUEST Trial A - Quality of life following mastectomy and breast reconstruction |
| ISRCTN | ISRCTN38846532 |
| ClinicalTrials.gov identifier | |
| Public title | QUEST Trial A - Quality of life following mastectomy and breast reconstruction |
| 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 |
| Serial number at source | CRUK/08/027 |
| 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.
As of 21/09/2011 the anticipated 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. |
| Lay summary | http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-how-women-feel-about-themselves-after-breast-reconstruction-during-surgery-breast-cancer |
| Ethics approval | South West 2 Research Ethics Committee on 11/09/2010 (ref: 10/H0206/41) |
| Study design | Phase III multicentre parallel randomised feasibility trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Breast cancer |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/08/2011 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 55 |
| Interventions | 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. |
| 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) |
| Secondary outcome measure(s) | 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 |
| Sources of funding |
1. Cancer Research UK (CRUK) (UK)
2. BUPA Foundation (UK) 3. University Hospitals of Bristol NHS Foundation Trust (UK) - Above and Beyond Charities 4. Allergan Aesthetics (UK) 5. Royal College of Surgeons of England (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Zoe Winters |
| Address |
Bristol Royal Infirmary
Clinical Sciences South Bristol Level 7, Marlborough Street |
| City/town | Bristol |
| Zip/Postcode | BR2 8HW |
| Country | United Kingdom |
| Tel | +44 (0)117 928 2365 |
| Fax | +44 (0)117 925 2736 |
| zoe.winters@bristol.ac.uk | |
| Sponsor | University Hospitals of Bristol NHS Foundation Trust (UK) |
| Address |
Trust Headquarters
Marlborough Street |
| City/town | Bristol |
| Zip/Postcode | BS1 3NU |
| Country | United Kingdom |
| Sponsor website: | http://www.uhbristol.nhs.uk/ |
| Date applied | 15/12/2009 |
| Last edited | 21/12/2011 |
| Date ISRCTN assigned | 06/01/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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