The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03091764




Registration number
NCT03091764
Ethics application status
Date submitted
21/03/2017
Date registered
27/03/2017
Date last updated
14/05/2020

Titles & IDs
Public title
Evaluation of a Patient-Reported Symptom Index for NMIBC
Scientific title
Psychometric Evaluation of a Patient-Reported Symptom Index for Non-Muscle Invasive Bladder Cancer: Field Testing
Secondary ID [1] 0 0
APP1103036
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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)

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)

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
NMIBC-SI - non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)
Timepoint [1] 0 0
Field test 1: once only (cross-sectional). Field test 2: four time-points over 1 year (longitudinal)
Secondary outcome [1] 0 0
QLQC-30 - EORTC cancer quality of life questionnaire
Timepoint [1] 0 0
Field test 2: four time-points over 1 year
Secondary outcome [2] 0 0
NMIBC24 - EORTC superficial bladder cancer questionnaire
Timepoint [2] 0 0
Field test 2: four time-points over 1 year

Eligibility
Key inclusion criteria
Field test 1:



- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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



- 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [4] 0 0
The Urological Cancer Centre, Westmead Specialist Centre - Westmead
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Mater Misericordiae Limited - South Brisbane
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Austin Health - Heidelberg
Recruitment hospital [9] 0 0
Alfred Health - Melbourne
Recruitment hospital [10] 0 0
Monash Health - Moorabbin
Recruitment hospital [11] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [12] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3189 - Moorabbin
Recruitment postcode(s) [10] 0 0
3052 - Parkville
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Tauranga
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cancer Council New South Wales
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03091764
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Manish Patel, MBBS,PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Rutherford, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 8627 1583
Fax 0 0
Email 0 0
claudia.rutherford@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03091764