Quality of life after bladder cancer
| ISRCTN | ISRCTN38750433 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38750433 |
| IRAS number | 246850 |
| Secondary identifying numbers | CPMS 39645, IRAS 246850 |
- Submission date
- 26/11/2018
- Registration date
- 25/01/2019
- Last edited
- 16/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
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 May 2025
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
Contact information
Scientific
Research & Development Office
Brighton & Sussex University Hospitals NHS Trust
16 Bloomsbury House
Brighton
BN1 2HQ
United Kingdom
| Phone | +44 (0)1273696955 ext 67893 |
|---|---|
| Bsu-tr.qabc@nhs.net |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Quality of Life After Bladder Cancer (Q-ABC): a comparison of patient related outcomes following radical surgery and radiotherapy |
| Study 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(s) | London (Surrey Borders), 25/09/2018, ref: 18/LO/1516 |
| Condition | Bladder cancer |
| 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 |
| 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 study start date | 09/08/2018 |
| Overall study end date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 376; UK Sample Size: 376 |
| 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 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 | 31/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Harwick
Stockton on Tees
TS19 8PE
United Kingdom
Marie Curie Research Wing
Mount Vernon Cancer Centre
Upper West
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
Kent Oncology Centre
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
135A, Park View
Park Road
Worthing
BN11 2AP
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Box 279(S4)
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Clinical Research Unit
Oldham
OL1 2JH
United Kingdom
Beacon Centre
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Pointer Court
Lancaster
LA1 4RP
United Kingdom
Sunrise Centre
Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom
Floor E
City Hospitals Sunderland NHS Foundation Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Clatterbridge Road
Bebington
CH63 4JY
United Kingdom
Ground Floor
Orange Zone
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Oncology Research Department 018
Haematology/Oncology Day Unit
Edith Cavell Campus
Bretton Gate
Peterborough
PE3 9GZ
United Kingdom
Research & Innovation
Stockport NHS Foundation Trust
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Clinical Research Dept
Polgate Ward
Kings Drive
Eastbourne
BN21 2UD
United Kingdom
Oncology, N045
Heath Road
Ipswich
IP4 5PD
United Kingdom
Fountain Street
Ashton Under Lyne
OL6 9RW
United Kingdom
Colney Lane
Norwich
NR4 7UY
United Kingdom
Cancer Reseach Office
Room 3.43, 2nd Floor
Park View Offices
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Avondale Unit
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
| Phone | +44 (0)1273 696955 x7497 |
|---|---|
| scott.harfield@bsuh.nhs.uk |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Varian Medical Systems, Inc., Varian Associates, 瓦里安医疗系统公
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 31/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
16/03/2024: The following changes were made:
1. The overall study end date was changed from 31/05/2024 to 31/05/2025.
2. The intention to publish date was changed from 31/05/2025 to 31/05/2026.
05/01/2022: The recruitment end date was changed from 31/12/2021 to 31/03/2022.
02/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2020 to 31/12/2021.
2. The overall trial end date was changed from 31/05/2023 to 31/05/2024.
3. The intention to publish date was changed from 31/05/2024 to 31/05/2025.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused. The IRAS number has also been added.
07/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 31/12/2020.
2. The overall trial end date has been changed from 31/10/2022 to 31/05/2023.
3. The intention to publish date has been changed from 31/10/2023 to 31/05/2024.
25/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Bladder Cancer; Health Category: Cancer and neoplasms; Disease/Condition: Malignant neoplasms of urinary tract" to "Bladder cancer" following a request from the NIHR.
