- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03091764
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New South Wales
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Concord, New South Wales, Australia, 2139
- Concord Hospital
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St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Wagga Wagga, New South Wales, Australia, 2650
- Riverina Cancer Care Centre
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Westmead, New South Wales, Australia, 2145
- The Urological Cancer Centre, Westmead Specialist Centre
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Mater Misericordiae Limited
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Victoria
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
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Heidelberg, Victoria, Australia, 3084
- Austin Health
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Melbourne, Victoria, Australia, 3004
- Alfred Health
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Moorabbin, Victoria, Australia, 3189
- Monash Health
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Parkville, Victoria, Australia, 3052
- Royal Melbourne Hospital
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital
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British Columbia
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Vancouver, British Columbia, Canada
- University of British Columbia
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Christchurch, New Zealand, 8013
- Canterbury Urology Research Trust
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Tauranga, New Zealand, 3140
- Tauranga Urology Research
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Manchester
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Salford, Manchester, United Kingdom, M5 5AP
- Salford Royal NHS Foundation Trust
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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NMIBC Patient High Risk
Any of the following:
(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
All cases between High and Low Risk (Patients requiring intravesical therapy which lasts between 6 weeks to 3 years) |
NMIBC Patient Low Risk
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NMIBC-SI development and validation
Time Frame: Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
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non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)
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Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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QLQC-30
Time Frame: Field test 2: four time-points over 1 year
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EORTC cancer quality of life questionnaire
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Field test 2: four time-points over 1 year
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NMIBC24
Time Frame: Field test 2: four time-points over 1 year
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EORTC superficial bladder cancer questionnaire
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Field test 2: four time-points over 1 year
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NMIBC-SI long term
Time Frame: Field test 2: four time-points over 1 year
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non-muscle invasive bladder cancer symptom index (long-term follow-up, and differences between groups)
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Field test 2: four time-points over 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manish Patel, MBBS,PhD, University of Sydney
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APP1103036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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