Evaluation of a Patient-Reported Symptom Index for NMIBC

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Assess and compare key Patient-Reported Outcomes (PROs) across the full range of contemporary treatments for NMIBC, and over the disease trajectory including acute treatment and 1year survivorship; Compare PROs between patients with low, intermediate, and high risk NMIBC. 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.

Official Title
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Psychometric Evaluation of a Patient-Reported Symptom Index for Non-Muscle Invasive Bladder Cancer: Field Testing

Conditions
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Superficial Bladder Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NMIBC Patient High Risk<br>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) | |
| NMIBC Patient Intermediate Risk<br>All cases between High and Low Risk (Patients requiring intravesical therapy which lasts between 6 weeks to 3 years) | |
| NMIBC Patient Low Risk<br>Primary, solitary, Ta, LG/G1, <3cm, no CIS (Patients receiving frequent cystoscopies, possible tumour resections and single instillations of postoperative chemotherapy) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NMIBC-SI development and validation | non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study) | Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QLQC-30 | EORTC cancer quality of life questionnaire | Field test 2: four time-points over 1 year | 
| NMIBC24 | EORTC superficial bladder cancer questionnaire | 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) | Field test 2: four time-points over 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMIBC, non-muscle invasive bladder cancer, Patient reported outcome, Symptom burden, Questionnaire