Quality of life after bladder cancer (Q-ABC)
| ISRCTN | ISRCTN13881914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13881914 |
| Protocol serial number | 32210 |
| Sponsor | Brighton and Sussex University Hospitals NHS Trust |
| Funder | Pelican Cancer Foundation |
- Submission date
- 20/03/2017
- Registration date
- 06/04/2017
- Last edited
- 18/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Sally Appleyard
Public
Public
Clinical Investigation & Research Unit
Royal Sussex County Hospitals
Eastern Road
Brighton
BN2 5BE
United Kingdom
 ORCID ID |
0000-0001-8167-8048 |
|---|---|
| Phone | +44 |
| sally.appleyard@bsuh.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomised; Observational; Design type: Qualitative |
| Secondary study design | Cohort study |
| Participant information sheet | ISRCTN13881914_PIS_01Nov16_V1.3_Patient.docx |
| Scientific title | Quality of Life After Bladder Cancer - a qualitative interview study (Q-ABC-QIS) |
| Study objectives | The aim of this study is to use in depth interviews to explore the “lived experience” of patients and carers who have undergone, or supported someone through, treatment for bladder cancer. |
| Ethics approval(s) | South East Coast: Brighton & Sussex REC, 01/02/2017, ref: 16/LO/1638 |
| Health condition(s) or problem(s) studied | Specialty: Cancer, Primary sub-specialty: Bladder Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract |
| Intervention | Participants will have a single interview lasting approximately one hour. This will be at their home or hospital depending on the preference of the participant. There is no follow-up. The interview takes place 1-2 years after treatment. The interview involves discussion of how the cancer and treatment have impacted on their (for patients)/their relative/friend’s and their own (for carers) quality of life, including physical and emotional changes. The discussion will also cover their (for patients)/their relative/friend’s experience of deciding between treatments, if a choice was offered. |
| Intervention type | Other |
| Primary outcome measure(s) |
Quality of Life of patients and carers following radical treatment for bladder cancer, explored using interviews, at a single time point between 1-2 years post treatment. |
| Key secondary outcome measure(s) |
1. Experience of the decision-making process relating to radical treatment for bladder cancer, explored using interviews, at a single time point between 1-2 years post treatment |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Adult patients > 18 years 2. Diagnosis of Muscle invasive bladder cancer 3. Treated with either radical cystectomy or radical (chemo-)radiotherapy between 1 and 2 years prior to study. 4. English speaking sufficient for in depth interview Carer: 1. Informal carer of a person who fulfils 1-3 above (recognising that this person may no longer fulfil a “caring” role but did so during treatment) 2. English speaking sufficient for in depth interview |
| Key exclusion criteria | Recurrent disease |
| Date of first enrolment | 02/01/2017 |
| Date of final enrolment | 01/10/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Royal Sussex County Hosptial
Eastern Road
Brighton
BN2 5BE
United Kingdom
Brighton
BN2 5BE
United Kingdom
Eastbourne District General Hospital
Kings Drive
Eastbourne
BN21 2UD
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Worthing
BN11 2DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from sally.appleyard@bsuh.nhs.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 18/02/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version V1.3 | 01/11/2016 | 21/04/2017 | No | Yes |
| Participant information sheet | version V1.1 | 01/11/2016 | 21/04/2017 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN13881914_PIS_01Nov16_V1.3_Patient.docx
- Uploaded 21/04/2017
- ISRCTN13881914_PIS_01Nov16_V1.1_Carer.docx
- Uploaded 21/04/2017
Editorial Notes
18/02/2022: Publication reference added.
16/10/2017: Cancer Help UK lay summary link added to plain English summary field
15/09/2017: Internal review.
06/06/2017: Internal review.
21/04/2017: The participant information sheets have been uploaded.
