Clinical trial · Observational
Evaluation of a Patient-Reported Symptom Index for NMIBC
Psychometric Evaluation of a Patient-Reported Symptom Index for Non-Muscle Invasive Bladder Cancer: Field Testing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Superficial Bladder Cancer | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- NMIBC Patient High Risk
- description
- 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)
- label
- NMIBC Patient Intermediate Risk
- description
- All cases between High and Low Risk (Patients requiring intravesical therapy which lasts between 6 weeks to 3 years)
- label
- NMIBC Patient Low Risk
- description
- Primary, solitary, Ta, LG/G1, \<3cm, no CIS (Patients receiving frequent cystoscopies, possible tumour resections and single instillations of postoperative chemotherapy)
Primary outcomes (1)
- measure
- NMIBC-SI development and validation
- timeFrame
- Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Field test 1: Inclusion Criteria: * diagnosed NMIBC * Adult (\>18yrs) * able to read and understand English * undergoing active treatment (i.e. one week after tumour resection or intravesical therapy) or completed final treatment for NMIBC within the last week Exclusion Criteria: * unconscious or confused * have cognitive impairment * unable to speak, read and/or write in English * diagnosed with muscle invasive disease * unable to provide informed consent Field test 2: Inclusion Criteria: * newly diagnosed NMIBC * Adult (\>18yrs) * able to read and understand English * after imaging or flexible cystoscopy, and before active treatment * either before endoscopic resection, or more than 4 weeks since endoscopic resection, but before active/ongoing treatment Exclusion Criteria: * unconscious or confused * have cognitive impairment * unable to speak, read and/or write in English * diagnosed with muscle invasive disease * unable to provide informed consent * currently undergoing active treatment for any bladder cancer, or finished treatment within last 3 years.
References
Publications (1)
- BACKGROUNDRutherford C, King MT, Smith DP, Costa DS, Tait MA, Patel MI; NMIBC-SI Working Group. Psychometric Evaluation of a Patient-Reported Symptom Index for Nonmuscle Invasive Bladder Cancer: Field Testing Protocol. JMIR Res Protoc. 2017 Nov 8;6(11):e216. doi: 10.2196/resprot.8761. PMID 29117930