An observational study in Superficial Bladder Cancer, sponsored by University of Sydney. Completed at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-13.
Sponsored by University of Sydney · Observational
This project will develop and evaluate a patient-reported symptom index to assess the impact of treatment for non-muscle invasive bladder cancer on patient burden, toxicity, symptoms and side effects. The symptom index will provide a method for assessing treatments from the patient's perspective; help healthcare professionals make better informed treatment decisions, and provide a method to be able to effectively evaluate treatments for non-muscle invasive bladder cancer.
The overarching aim of this research is to develop and evaluate a patient-reported Symptom Index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients, reliable, valid and responsive, and fit for purpose in clinical trials and clinical practice.
Specific clinical aims:
In field test 1, 200 participants will complete one questionnaire either in hard copy (pencil and paper) or online, at a time that is convenient for the participant. The questionnaire may take up to 20 minutes to complete.
In field test 2, 250 participants will complete quality of life questionnaires at four different time points; 1) before tumour resection, 2) 1 week after resection, 3) 8 weeks after resection, and 4) 1 year after resection. The questionnaires can be completed in the clinic or at home, either in hard copy (pencil and paper) or online, at a time that is convenient for the participant but still within the relevant time point. The questionnaires may take up to 30 minutes to complete.
273 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 116 are open to participants now.
This study's enrollment of 498 is above the median of 210 across 47 observational studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →University of Sydney is the lead sponsor of 94 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (aged ≥18 years) from participating centres diagnosed with NMIBC, able to read and understand English, and give their written informed consent will be included in the study.
Field test 1:
Inclusion Criteria:
Exclusion Criteria:
Field test 2:
Inclusion Criteria:
Exclusion Criteria:
Any of the following: * T1 tumours * CIS (carcinoma in situ) * Multiple and recurring and large (\>3cm) Ta, G1, G2 tumours (all these conditions must be presented) (Patients requiring intravesical Bacillus Calmette-Guérin (BCG) (immunotherapy), which starts with 6 week induction treatment and continues with maintenance for 1 to 3 years)
All cases between High and Low Risk (Patients requiring intravesical therapy which lasts between 6 weeks to 3 years)
Primary, solitary, Ta, LG/G1, \<3cm, no CIS (Patients receiving frequent cystoscopies, possible tumour resections and single instillations of postoperative chemotherapy)
NMIBC-SI development and validation
non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)
Time frame: Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
QLQC-30
EORTC cancer quality of life questionnaire
Time frame: Field test 2: four time-points over 1 year
NMIBC24
EORTC superficial bladder cancer questionnaire
Time frame: Field test 2: four time-points over 1 year
NMIBC-SI long term
non-muscle invasive bladder cancer symptom index (long-term follow-up, and differences between groups)
Time frame: Field test 2: four time-points over 1 year
Plan to share: No
Ran from Jul 2016 to primary completion in Jul 2020, 48 months.
Of 27 observational studies under Non-Muscle Invasive Bladder Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 66. This study's 48 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Non-Muscle Invasive Bladder Neoplasms →
University of Sydney