Condition category
Cancer
Date applied
15/12/2009
Date assigned
06/01/2010
Last edited
21/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Zoe Winters

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRUK/08/027

Study information

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

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

South West 2 Research Ethics Committee on 11/09/2010 (ref: 10/H0206/42)

Study design

Phase III multicentre parallel randomised feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

07/07/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

55

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

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University Hospitals of Bristol NHS Foundation Trust (UK)

Sponsor details

Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
United Kingdom

Sponsor type

Government

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

BUPA Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Allergan Aesthetics (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal College of Surgeons of England (UK)

Alternative name(s)

RCS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25451179

Publication citations

Additional files

Editorial Notes