NMIBC-SI Evaluation

 Bladder — In Follow-up

NMIBC-SI Evaluation
Non-muscle invasive bladder cancer (NMIBC) makes up approximately 70-80% of all bladder cancer diagnoses. NMIBC is bladder cancer that has not yet invaded through the wall of the bladder. Treatment is generally intended to reduce the risk of the bladder cancer recurring or progressing to muscle invasive disease. Treatment involves endoscopic resection to the bladder tumours followed by potential intravesical chemotherapy or immunotherapy. Although treatments can significantly reduce the risk of recurrence and progression, there are both benefits and harms that are likely to vary between treatment options. However, little is known about the impact of these treatments on patients’ quality of life.

Phase I of the project involved qualitative research to develop a draft Non-Muscle Invasive Bladder Cancer Symptom Index (NMIBC-SI). The second phase of the project aims to evaluate the psychometric properties of the NMIBC-SI. This was conducted across two field tests:
• Field Test 1 was a cross-sectional study design asking participants to complete the draft NMIBC-SI questionnaire either on paper or lectronically. The purpose of Field Test 1 is to produce a shorter version of the NMIBC-SI by eliminating items with poor psychometric properties.
• Field Test 2 used a prospective longitudinal study design to evaluate the clinical validity of the final version of the NMIBC-SI. Participants were asked to complete the NMIBC-SI along with comparative questionnaires at different time-points during their treatment. The purpose of Field Test 2 is to assess the reliability, validity and responsiveness of the final version of the NMIBC-SI to ensure it is fit for purpose in clinical research.

ANZUP was running this trial in collaboration with Cancer Australia and Cancer Council NSW. This study is being sponsored by the University of Sydney.
If you think this trial might be right for you, please ask your doctor.
Trial Title
Developing a Patient-Reported Symptom Index for Non-muscle Invasive Bladder Cancer
Cancer Type
Trial Status
In Follow-up
Protocol Number
Study Chair
A/Prof Manish Patel; Prof Shomik Sengupta
Patient Population
Adults treated for non-muscle invasive bladder cancer
Recruitment Target
450 participants
Detailed Information
Participating Centres
Concord Repatriation General Hospital
Riverina Cancer Care Centre
The Urological Centre
Westmead Hospital - Western Sydney Local Health District

Alfred Health - The Alfred Hospital
Austin Health
Eastern Health
Monash Medical Centre
Royal Melbourne Hospital

Mater Hospital Brisbane

Fiona Stanley Hospital

Canterbury Urology Research Trust
Tauranga Urology Research

Salford Hospital

University of British Columbia

Mayo Clinic
University of Minnesota Hospital
University of Kansas