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 take 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 2019
Who is funding the study?
MAS Cancer Foundation (Sweden)
Who is the main contact?
Dr Fredrik Liedberg
Patient Reported Outcome Measures after radical cystectomy
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.
Lund University, ref: 2014/832
Primary study design
Secondary study design
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Bladder cancer treated with radical cystectomy
Participants are asked to fill in two questionnaires, tFACT-G and FACT-VCI to assess their HRQoL after radical cystectomy.
Primary outcome measures
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 trial start date
Overall trial end date
Participant inclusion criteria
Patients with bladder cancer scheduled to have a radical cystectomy.
Target number of participants
Participant exclusion criteria
Does not give consent.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Skåne University Hospital, Lund University
205 02 Malmö
MAS Cancer Foundation (Sweden)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The study will be published in a peer reviewed journal in 2020
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting