Evaluation of a Patient-Reported Symptom Index for NMIBC

Superficial Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091764
• Other study ID #: APP1103036
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2021
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: August 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Superficial Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Concord Hospital	Concord	New South Wales
Australia	Austin Health	Heidelberg	Victoria
Australia	Alfred Health	Melbourne	Victoria
Australia	Monash Health	Moorabbin	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Mater Misericordiae Limited	South Brisbane	Queensland
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
Canada	University of British Columbia	Vancouver	British Columbia
New Zealand	Canterbury Urology Research Trust	Christchurch
New Zealand	Tauranga Urology Research	Tauranga
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Manchester
United States	University of Kansas	Kansas City	Kansas
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Sydney	Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Cancer Australia, Cancer Council New South Wales

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NMIBC-SI development and validation	non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)	Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
Secondary	QLQC-30	EORTC cancer quality of life questionnaire	Field test 2: four time-points over 1 year
Secondary	NMIBC24	EORTC superficial bladder cancer questionnaire	Field test 2: four time-points over 1 year
Secondary	NMIBC-SI long term	non-muscle invasive bladder cancer symptom index (long-term follow-up, and differences between groups)	Field test 2: four time-points over 1 year