Health related quality of life after radical cystectomy
| ISRCTN | ISRCTN99427820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99427820 |
- Submission date
- 09/09/2015
- Registration date
- 07/10/2015
- Last edited
- 09/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Bladder cancer refers to a condition where a tumour grows in the lining of the bladder which can then spread to other tissues in the body. The most common symptom is blood in the urine. Transurethral resection for bladder cancer, a surgery that involves removing the cancer cells from the bladder, is the most common urologic cancer operation today. In cases where transurethral resection shows that the tumour has spread into the surrounding muscle, the standard treatment is radical cystectomy (removal of the bladder, surrounding lymph nodes, part of the urethra and other nearby organs that may have cancer cells). Patients considered well enough may have chemotherapy before surgery to increase the chance of a cure. To study the outcome after a radical cystectomy, the health-related quality of life (HRQoL) is a measure that takes both the impact of the disease and treatment-related side effects into account. HRQoL is rarely measured for bladder cancer patients after treatment due to a lack of bladder cancer-specific validated questionnaires and its various treatments. FACT (Functional Assessment of Cancer Therapy Scale) is designed to measure the physical, social, emotional and functional wellbeing of patients after treatment. It was originally developed for use in different kinds of gastric surgery and has later been validated for other cancers. For patients with bladder cancer treated with radical cystectomy, various questionnaires including EORTC-QLQ30-BLM30, FACT-VCI (Vanderbilt Cystectomy Index) and BCI (Bladder Cancer Index) have all been validated for use. Of these questionnaires, the FACT-VCI is based on the FACT, with diversion-related questions (i.e. questions about rerouting urine flow away from its normal path) added, making the questionnaire particularly useful in the setting before (FACT-G) and after (FACT-VCI) radical cystectomy. The aim of this study is to investigate health-related quality of life (HRQoL) using these questionnaires before and after radical cystectomy in relation to whether they have had chemotherapy, type of urinary diversion and complications after surgery.
Who can participate?
Patients treated with primary radical cystectomy in Sweden.
What does the study involve?
Participants complete the questionnaire with FACT-G before surgery and FACT-VCI after surgery. Comparisons in HRQoL are then made taking into account whether they have had chemotherapy, type of urinary diversion and whether or not they have any complications within 90 days of surgery.
What are the possible benefits and risks of participating?
The benefits for participants are a more thorough registration of health changes after radical surgery. There are no risks.
Where is the study run from?
Skåne University Hospital, Lund University (Sweden)
When is the study starting and how long is it expected to run for?
January 2016 to January 2028
Who is funding the study?
MAS Cancer Foundation (Sweden)
Who is the main contact?
Dr Fredrik Liedberg
Contact information
Scientific
Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-20502
Sweden
Study information
| Study design | Observational cohort |
|---|---|
| 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 contact details to request a participant information sheet |
| Scientific title | Patient Reported Outcome Measures after radical cystectomy |
| Study acronym | PROM |
| Study hypothesis | The aim of this study is to investigate health related quality of life (HRQoL) before and after radical cystectomy in relation to neoadjuvant chemotherapy, type of urinary diversion and complications after surgery. |
| Ethics approval(s) | Lund University, ref: 2014/832 |
| Condition | Bladder cancer treated with radical cystectomy |
| Intervention | Participants are asked to fill in two questionnaires, tFACT-G and FACT-VCI to assess their HRQoL after radical cystectomy. |
| Intervention type | Other |
| Primary outcome measure | HRQoL at 12 months after radical cystectomy for bladder cancer, assessed with tFACT-G and FACT-VCI. |
| Secondary outcome measures | The secondary outcome measures are the HRQoL items functional wellbeing, social wellbeing, emotional wellbeing and physical wellbeing. These are measured 12 months after surgery. The method used is the FACT-VCI questionnaire, as for the primary outcome measures. |
| Overall study start date | 01/01/2016 |
| Overall study end date | 01/01/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 900 |
| Participant inclusion criteria | Patients with bladder cancer scheduled to have a radical cystectomy |
| Participant exclusion criteria | Does not give consent |
| Recruitment start date | 01/01/2016 |
| Recruitment end date | 01/03/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centre
205 02 Malmö
Sweden
Sponsor information
University/education
205 02
Malmö
205 02
Sweden
"ROR" |
https://ror.org/012a77v79 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/01/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study will be published in a peer reviewed journal in 2024. |
| IPD sharing plan |
Editorial Notes
09/04/2025: The recruitment end date was changed from 01/01/2026 to 01/03/2027.
10/01/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2024 to 01/01/2026.
2. The overall end date was changed from 01/01/2026 to 01/01/2028.
3. The intention to publish date was changed from 01/01/2027 to 01/01/2030.
20/01/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2021 to 01/01/2024.
2. The overall end date was changed from 01/01/2023 to 01/01/2026.
3. The intention to publish date was changed from 01/01/2024 to 01/01/2027.
15/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2019 to 01/01/2021.
2. The overall trial end date was changed from 01/01/2019 to 01/01/2023.
