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

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


  • Org Study ID: APP1103036
  • Secondary ID:
  • NCT ID: NCT03091764
  • NCT Alias:
  • Sponsor: University of Sydney - Other
  • Source: University of Sydney

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.

Overal Status Start Date Phase Study Type
Recruiting July 1, 2016 Observational [Patient Registry]

Primary Outcomes:

Primary Outcome 1 - Measure: NMIBC-SI

Primary Outcome 1 - Time Frame: Field test 1: once only (cross-sectional). Field test 2: four time-points over 1 year (longitudinal)

Condition:

  • Superficial Bladder Cancer

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 but before endoscopic resection (i.e. before
active 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 5 years.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Manish Patel, MBBS,PhD

Role: Principal Investigator

Affiliation: University of Sydney

Overall Contact

Name: Claudia Rutherford, PhD

Phone: +61 2 8627 1583

Email: claudia.rutherford@sydney.edu.au

Locations

Facility Status Contact
University of Kansas
Kansas City, Kansas 66160
United States
Not yet recruiting Jeffrey M Holzbeierlein, MD, FACS

University of Minnesota
Minneapolis, Minnesota 55455
United States
Not yet recruiting Resha Tejpaul

Mayo Clinic
Rochester, Minnesota 55905
United States
Not yet recruiting
Box Hill Hospital
Box Hill, New South Wales 3128
Australia
Not yet recruiting
Concord Hospital
Concord, New South Wales 2139
Australia
Recruiting
0297676789
Royal North Shore Hospital
St Leonards, New South Wales 2065
Australia
Recruiting
The Urological Cancer Centre, Westmead Specialist Centre
Westmead, New South Wales 2145
Australia
Recruiting
Westmead Hospital
Westmead, New South Wales 2145
Australia
Recruiting
Mater Misericordiae Limited
South Brisbane, Queensland 4101
Australia
Recruiting
Austin Health
Heidelberg, Victoria 3084
Australia
Recruiting
Monash Health
Moorabbin, Victoria 3189
Australia
Recruiting
Royal Melbourne Hospital
Parkville, Victoria 3052
Australia
Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia 6150
Australia
Recruiting
Canterbury Urology Research Trust
Christchurch, 8013
New Zealand
Not yet recruiting
Tauranga Urology Research
Tauranga, 3140
New Zealand
Recruiting
Salford Royal NHS Foundation Trust
Salford, Manchester M5 5AP
United Kingdom
Not yet recruiting