Skip to main content
OpenTrials
Completed

NCT Number: NCT03091764

Evaluation of a Patient-Reported Symptom Index for NMIBC

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Superficial Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Concord Hospital, Concord, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. QLQC-30

    Time frame: Field test 2: four time-points over 1 year

    EORTC cancer quality of life questionnaire

  2. NMIBC24

    Time frame: Field test 2: four time-points over 1 year

    EORTC superficial bladder cancer questionnaire

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group
  • Cancer Australia
  • Cancer Council New South Wales

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Mar 27, 2017
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.