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11 February 2012
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| [ Print-friendly version ] |
| QUEST Trial B - Quality of life following mastectomy and breast reconstruction |
| ISRCTN | ISRCTN92581226 |
| ClinicalTrials.gov identifier | |
| Public title | QUEST Trial B - Quality of life following mastectomy and breast reconstruction |
| Scientific title | A multicentre randomised trial to assess the impact of the timing of breast reconstruction on quality of life following mastectomy |
| Acronym | QUEST Trial B |
| Serial number at source | CRUK/08/027 |
| 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 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-comparing-how-women-feel-about-themselves-after-having-immediate-or-delayed-breast-reconstruction-surgery-quest-b |
| Ethics approval | South West 2 Research Ethics Committee on 11/09/2010 (ref: 10/H0206/42) |
| Study design | Phase III multicentre parallel randomised feasibility trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Breast cancer |
| Participants - 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 |
| 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. 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 |
| Anticipated start date | 07/07/2011 |
| 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 |
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. |
| 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 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 |
| 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 | BS2 8HW |
| Country | United Kingdom |
| 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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