Condition category
Cancer
Date applied
09/09/2015
Date assigned
07/10/2015
Last edited
07/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fredrik Liedberg

ORCID ID

Contact details

Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-20502
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Patient Reported Outcome Measures after radical cystectomy

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

Lund University, ref: 2014/832

Study design

Observational cohort

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 contact details to request a participant information sheet

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

Phase

Drug names

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

01/01/2016

Overall trial end date

01/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with bladder cancer scheduled to have a radical cystectomy.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

900

Participant exclusion criteria

Does not give consent.

Recruitment start date

01/01/2016

Recruitment end date

01/01/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Skåne University Hospital, Lund University
Malmö
205 02 Malmö
Sweden

Sponsor information

Organisation

Inst Translational Medicine, Lund University

Sponsor details

205 02
Malmö
205 02
Sweden

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

MAS Cancer Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study will be published in a peer reviewed journal in 2020

Intention to publish date

01/06/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes