Condition category
Cancer
Date applied
26/11/2018
Date assigned
25/01/2019
Last edited
25/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Patients who have bladder cancer which has invaded the wall of the bladder, but not escaped further, can be treated with either radiotherapy or surgery. Radiotherapy is X ray treatment which is given daily over 4-6 weeks, allowing patients to keep their bladder. Surgery involves removal of the bladder (cystectomy) with either formation of a stoma (an opening onto the tummy wall, draining urine into a bag) or a new internal bladder formed from a section of bowel. Patients may be offered a choice between treatments but there is not a great deal of information about the reality of life after treatment to help them decide. This study aims to collect information from patients before and after treatment to help patients and health care teams understand the impact of treatment on quality of life. A separate part of the study will explore the financial costs to patients and the health service of each treatment.

Who can participate?
Men and women aged 18 or over who have bladder cancer suitable for treatment with radiotherapy and surgery

What does the study involve?
Participants either have radiotherapy or surgery as decided by them in conjunction with their healthcare team. Being in the study does not affect the treatment the participant receives. Participants complete questionnaires before treatment and at 6, 12 and 24 months from the end of treatment. The questionnaires ask about symptoms, quality of life and thoughts about the future. Participants can choose to be part of the health economics sub-study – if so they also complete a questionnaire about the costs of treatment and use of healthcare before treatment and at 3, 6, 9 and 12 months after treatment. The first questionnaires are completed at the hospital during normal visits but may take up to 20 minutes to complete. After treatment all the questionnaires are posted to participants homes to be completed at their convenience.

What are the possible benefits and risks of participating?
Being in the study does not change standard treatment and so there are no additional side effects. There are no direct benefits in participating, although completing questionnaires may help participants identify problems. The risks of enrolling are that the questionnaires might trigger difficult or distressing thoughts. The questionnaires being used have been developed in patients with cancer and reviewed by patients involved in designing the study who have not identified any concerns. Support will be available for participants if distress occurs.

Where is the study run from?
The study is being run from Brighton & Sussex Hospitals. Approximately 35 centres across the UK will take part in the study.

When is the study starting and how long is it expected to run for?
August 2018 to October 2022

Who is funding the study?
The study is funded by Roche (a pharmaceutical company); Varian (a radiotherapy company) and two charities: the Sussex Cancer Fund & Fight Bladder Cancer.

Who is the main contact?
Isobelle Coombes (study manager)
Bsu-tr.qabc@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Isobelle Coombes

ORCID ID

Contact details

Research & Development Office
Brighton & Sussex University Hospitals NHS Trust
16 Bloomsbury House
Brighton
BN1 2HQ
United Kingdom
+44 (0)1273696955 ext 67893
Bsu-tr.qabc@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39645

Study information

Scientific title

Quality of Life After Bladder Cancer (Q-ABC): a comparison of patient related outcomes following radical surgery and radiotherapy

Acronym

Q-ABC V1.0

Study hypothesis

Muscle invasive bladder cancer can be treated with radiotherapy or surgery. This study will explore the impact on quality of life.

Ethics approval

London (Surrey Borders), 25/09/2018, ref: 18/LO/1516

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Specialty: Cancer, Primary sub-specialty: Bladder Cancer; Health Category: Cancer and neoplasms; Disease/Condition: Malignant neoplasms of urinary tract

Intervention

This is a observational study collecting patient-reported quality of life questionnaires before and for 2 years following treatment for bladder cancer. It is not possible to randomise between these treatments (from a previous closed RCT) and so contemporaneous cohorts of patients are the best way of obtaining information that might be compared. 376 patients (188 in each treatment group) will be recruited in 25-35 centres across the UK.

Participants will be recruited before starting any treatment including chemotherapy (which may precede surgery or radiotherapy). They will complete questionnaires before treatment, after chemotherapy (if applicable) and then at 6, 12 and 24 months from the end of treatment.

The initial questionnaires will be completed at the hospital and from 6 months the questionnaires will be posted to participants. The questionnaires cover bladder cancer symptoms (FACT-Bl), quality of life (FACT-Bl & EQ-5D-5L) and thoughts about cancer recurrence (Fear of recurrence score) and it is estimated that these will take max 15 minutes to complete.

150 participants (of the 376, 75 from each group) will also be recruited to a health economic sub-study and asked to complete an additional questionnaire 3 monthly for the first year after treatment. This covers health service use and time off work/caring responsibilities to estimate societal costs (UK Cancer costs questionnaire). It is estimated that this will take 5-10 minutes to complete and the follow-up questionnaires will be posted to the participants.

Additional information will be collected by the local research nurses including disease and demographic characteristics and medical history at baseline. At 12 and 24 months research nurses will record any recurrence of bladder cancer, if the participant has died and what tests and appointments they have had in the last year. At 12 months the research nurse will complete with the participant (in person at their normal clinic visit or by phone) a symptom scoring questionnaire."

Intervention type

Other

Phase

Drug names

Primary outcome measure

Quality of life is measured by the EQ-5D-5L and the FACT-Bl questionnaires at baseline, 6, 12 and 24 months

Secondary outcome measures

1. Participant characteristics measured using the study specific CRF which includes demographic information, cancer staging, 6 items from the CTCAE V5.0 and Charlson comorbidity index at baseline
2. Fear of recurrence measured using Kornblith fear of recurrence questionnaire at baseline, 12 and 24 months
3. Survival and recurrence rates measured via follow-up CRFs at 12 and 24 months
4. Clinician graded toxicity measured by a 5-item CTCAE V5.0 and patient reported toxicity via specific items on the FACT-Bl questionnaire at 12 months
5. Costs calculated from hospital use (from CRF data about treatment and follow-up) and patient-reported costs via the UK Cancer Costs questionnaire completed at baseline and 3 monthly for the first year

Overall trial start date

09/08/2018

Overall trial end date

31/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥ 16 years, no upper age limit
2. Any patient undergoing potentially curative radical treatments for confirmed muscle invasive bladder cancer by either surgery or radiotherapy
3. Willing to provide informed consent
4. English Language competence sufficient to complete questionnaires

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 376; UK Sample Size: 376

Participant exclusion criteria

1. Prior pelvic radiotherapy or surgery
2. Patients with bladder cancer other than transitional cell carcinoma
3. Patients who, in the judgement of the local PI, are not suitable for the study due to significant mental health disorders or cognitive impairment
4. Previous malignancy in the last 5 years except for: non-muscle invasive bladder cancer; non-melanoma skin cancer, CIS of cervix or LCIS of breast

Recruitment start date

13/10/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of North Tees
1st Floor, Middlefield Centre Harwick
Stockton on Tees
TS19 8PE
United Kingdom

Trial participating centre

Mount Vernon Hospital
Urology Research Team Marie Curie Research Wing Mount Vernon Cancer Centre Upper West Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Trial participating centre

Royal Sussex County Hospital
CIRU Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Maidstone Hospital
The Research Office Kent Oncology Centre Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Trial participating centre

Worthing Hospital
Research & Innovation department 135A, Park View Park Road
Worthing
BN11 2AP
United Kingdom

Trial participating centre

Derriford Hospital
Chestnut Unit, Level 7
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge Cancer Trials Centre Cambridge University Hospitals NHS Foundation Trust Box 279(S4) Cambridge Biomedical Campus Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Royal Oldham Hospital
Ward C1 Clinical Research Unit
Oldham
OL1 2JH
United Kingdom

Trial participating centre

Musgrove Park Hospital
Clinical Research Oncology Beacon Centre Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Royal Lancaster Infirmary
Research & Development Pointer Court
Lancaster
LA1 4RP
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Oncology Trials Sunrise Centre Royal Cornwall Hospitals NHS Trust Treliske
Truro
TR1 3LJ
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Clinical Trials Office Floor E City Hospitals Sunderland NHS Foundation Trust Kayll Road
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Clatterbridge Cancer Centre
Research & Innovation Dept Clatterbridge Road
Bebington
CH63 4JY
United Kingdom

Trial participating centre

Queen's Hospital
Cancer Trials Office Ground Floor Orange Zone Rom Valley Way
Romford
RM7 0AG
United Kingdom

Trial participating centre

Peterborough City Hospital
North West Anglia NHS Foundation Trust Oncology Research Department 018 Haematology/Oncology Day Unit Edith Cavell Campus Bretton Gate
Peterborough
PE3 9GZ
United Kingdom

Trial participating centre

Stepping Hill Hospital
Ward C2 Research & Innovation Stockport NHS Foundation Trust Poplar Grove
Stockport
SK2 7JE
United Kingdom

Trial participating centre

Eastbourne District General Hospital
East Sussex Healthcare NHS Trust Clinical Research Dept Polgate Ward Kings Drive
Eastbourne
BN21 2UD
United Kingdom

Trial participating centre

Ipswich Hospital
Cancer Research Office Oncology, N045 Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Tameside General Hospital
Tameside & Glossop Intergrated Care NHS Foundation Trust Fountain Street
Ashton Under Lyne
OL6 9RW
United Kingdom

Trial participating centre

Norfolk & Norwich University Hospital
Norfolk & Norwich Univerity Hospital Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Royal Blackburn Hospital
East Lancashire Hospitals NHS Trust Cancer Reseach Office Room 3.43, 2nd Floor Park View Offices Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Royal Preston Hospital
Lancashire Clinical Research Facility Avondale Unit Royal Preston Hospital Sharoe Green Lane Fulwood
Preston
PR2 9HT
United Kingdom

Sponsor information

Organisation

Brighton and Sussex University Hospitals NHS Trust

Sponsor details

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696955 x7497
scott.harfield@bsuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

F. Hoffmann-La Roche

Alternative name(s)

Hoffman-La Roche, F. Hoffmann-La Roche Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Funder name

Varian Medical Systems

Alternative name(s)

Varian Medical Systems, Inc., Varian

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Fight Bladder Cancer

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication in a high impact peer-reviewed journal
2. Presentation at conferences
3. Dissemination via national patient charity (Fight Bladder Cancer)

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ashok Nikapota. Anonymised aggregate level data, available after study publication, access to be determined by trial management group for specific purposes on a case by case basis.

Intention to publish date

31/10/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes