Clinical trial NCT03091764: Evaluation of a Patient-Reported Symptom Index for NMIBC
Official title: Psychometric Evaluation of a Patient-Reported Symptom Index for Non-Muscle Invasive Bladder Cancer: Field Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Bladder Cancer
Keywords: NMIBC
non-muscle invasive bladder cancer
Patient reported outcome
Symptom burden
Questionnaire
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Australian and New Zealand Urogenital and Prostate Cancer Trials Group
name: Cancer Australia
name: Cancer Council New South Wales
First posted: 2017-03-27
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (aged ≥18 years) from participating centres diagnosed with NMIBC, able to read and understand English, and give their written informed consent will be included in the study.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: NMIBC-SI development and validation
timeFrame: Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
Secondary outcomes:
measure: QLQC-30
timeFrame: Field test 2: four time-points over 1 year
measure: NMIBC24
timeFrame: Field test 2: four time-points over 1 year
measure: NMIBC-SI long term
timeFrame: Field test 2: four time-points over 1 year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Riverina Cancer Care Centre
state: New South Wales
city: Westmead
country: Australia
facility: The Urological Cancer Centre, Westmead Specialist Centre
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Moorabbin
country: Australia
facility: Monash Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Christchurch
country: New Zealand
facility: Canterbury Urology Research Trust
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Manchester
Study officials:
affiliation: University of Sydney
name: Manish Patel, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.