Evaluation of a Patient-Reported Symptom Index for NMIBC
NCT ID: NCT03091764
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
498 participants
OBSERVATIONAL
2016-07-01
2021-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NMIBC Patient High Risk
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)
No interventions assigned to this group
NMIBC Patient Intermediate Risk
All cases between High and Low Risk
(Patients requiring intravesical therapy which lasts between 6 weeks to 3 years)
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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:
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
Cancer Australia
OTHER
Cancer Council New South Wales
OTHER
University of Sydney
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Manish Patel, MBBS,PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sydney
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kansas
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Concord Hospital
Concord, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia
The Urological Cancer Centre, Westmead Specialist Centre
Westmead, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Monash Health
Moorabbin, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
University of British Columbia
Vancouver, British Columbia, Canada
Canterbury Urology Research Trust
Christchurch, , New Zealand
Tauranga Urology Research
Tauranga, , New Zealand
Salford Royal NHS Foundation Trust
Salford, Manchester, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rutherford 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APP1103036
Identifier Type: -
Identifier Source: org_study_id