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

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

Condition: Superficial Bladder Cancer

Purpose: 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.

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03091764

Sponsor: University of Sydney

Primary Outcome Measures:

  • Measure: NMIBC-SI
  • Time Frame: Field test 1: once only (cross-sectional). Field test 2: four time-points over 1 year (longitudinal)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: QLQC-30
  • Time Frame: Field test 2: four time-points over 1 year
  • Safety Issue:
  • Measure: NMIBC24
  • Time Frame: Field test 2: four time-points over 1 year
  • Safety Issue:

Estimated Enrollment: 450

Study Start Date: July 1, 2016

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 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.

Contact:

  • Claudia Rutherford, PhD
  • +61 2 8627 1583

Locations:

  • University of Kansas
  • Kansas City Kansas 66160 United States
  • University of Minnesota
  • Minneapolis Minnesota 55455 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 United States
  • Concord Hospital
  • Concord New South Wales 2139 Australia
  • Royal North Shore Hospital
  • St Leonards New South Wales 2065 Australia
  • Riverina Cancer Care Centre
  • Wagga Wagga New South Wales 2650 Australia
  • The Urological Cancer Centre, Westmead Specialist Centre
  • Westmead New South Wales 2145 Australia
  • Westmead Hospital
  • Westmead New South Wales 2145 Australia
  • Mater Misericordiae Limited
  • South Brisbane Queensland 4101 Australia
  • Box Hill Hospital
  • Box Hill Victoria 3128 Australia
  • Austin Health
  • Heidelberg Victoria 3084 Australia
  • Alfred Health
  • Melbourne Victoria 3004 Australia
  • Monash Health
  • Moorabbin Victoria 3189 Australia
  • Royal Melbourne Hospital
  • Parkville Victoria 3052 Australia
  • Fiona Stanley Hospital
  • Murdoch Western Australia 6150 Australia
  • Canterbury Urology Research Trust
  • Christchurch 8013 New Zealand
  • Tauranga Urology Research
  • Tauranga 3140 New Zealand
  • Salford Royal NHS Foundation Trust
  • Salford Manchester M5 5AP United Kingdom

View trial on ClinicalTrials.gov

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