Evaluation of a Patient-Reported Symptom Index for NMIBC

October 11, 2021 updated by: University of Sydney

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

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Wagga Wagga, New South Wales, Australia, 2650
        • Riverina Cancer Care Centre
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
      • Westmead, New South Wales, Australia, 2145
        • The Urological Cancer Centre, Westmead Specialist Centre
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health
      • Moorabbin, Victoria, Australia, 3189
        • Monash Health
      • Parkville, Victoria, Australia, 3052
        • Royal Melbourne Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
      • Christchurch, New Zealand, 8013
        • Canterbury Urology Research Trust
      • Tauranga, New Zealand, 3140
        • Tauranga Urology Research
    • Manchester
      • Salford, Manchester, United Kingdom, M5 5AP
        • Salford Royal NHS Foundation Trust
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NMIBC-SI development and validation
Time Frame: 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)
Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QLQC-30
Time Frame: Field test 2: four time-points over 1 year
EORTC cancer quality of life questionnaire
Field test 2: four time-points over 1 year
NMIBC24
Time Frame: Field test 2: four time-points over 1 year
EORTC superficial bladder cancer questionnaire
Field test 2: four time-points over 1 year
NMIBC-SI long term
Time Frame: Field test 2: four time-points over 1 year
non-muscle invasive bladder cancer symptom index (long-term follow-up, and differences between groups)
Field test 2: four time-points over 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Manish Patel, MBBS,PhD, University of Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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