Evaluation of a Patient-Reported Symptom Index for NMIBC
- Conditions
- Superficial Bladder Cancer
- Registration Number
- NCT03091764
- Lead Sponsor
- University of Sydney
- Brief Summary
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
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 survivorshipอพ
* 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 pointsอพ 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 498
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method NMIBC-SI development and validation Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal) non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)
- Secondary Outcome Measures
Name Time Method QLQC-30 Field test 2: four time-points over 1 year EORTC cancer quality of life questionnaire
NMIBC24 Field test 2: four time-points over 1 year EORTC superficial bladder cancer questionnaire
NMIBC-SI long term Field test 2: four time-points over 1 year non-muscle invasive bladder cancer symptom index (long-term follow-up, and differences between groups)
Trial Locations
- Locations (19)
Royal North Shore Hospital
๐ฆ๐บSt Leonards, New South Wales, Australia
University of Kansas
๐บ๐ธKansas City, Kansas, United States
Concord Hospital
๐ฆ๐บConcord, New South Wales, Australia
The Urological Cancer Centre, Westmead Specialist Centre
๐ฆ๐บWestmead, New South Wales, Australia
Riverina Cancer Care Centre
๐ฆ๐บWagga Wagga, New South Wales, Australia
Westmead Hospital
๐ฆ๐บWestmead, New South Wales, Australia
Mater Misericordiae Limited
๐ฆ๐บSouth Brisbane, Queensland, Australia
Box Hill Hospital
๐ฆ๐บBox Hill, Victoria, Australia
Austin Health
๐ฆ๐บHeidelberg, Victoria, Australia
Alfred Health
๐ฆ๐บMelbourne, Victoria, Australia
Salford Royal NHS Foundation Trust
๐ฌ๐งSalford, Manchester, United Kingdom
Monash Health
๐ฆ๐บMoorabbin, Victoria, Australia
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
University of British Columbia
๐จ๐ฆVancouver, British Columbia, Canada
University of Minnesota
๐บ๐ธMinneapolis, Minnesota, United States
Royal Melbourne Hospital
๐ฆ๐บParkville, Victoria, Australia
Canterbury Urology Research Trust
๐ณ๐ฟChristchurch, New Zealand
Fiona Stanley Hospital
๐ฆ๐บMurdoch, Western Australia, Australia
Tauranga Urology Research
๐ณ๐ฟTauranga, New Zealand