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Evaluation of a Patient-Reported Symptom Index for NMIBC

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ClinicalTrials.gov Identifier: NCT03091764
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Cancer Australia
Cancer Council New South Wales
Information provided by (Responsible Party):
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.

Condition or disease
Superficial 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Psychometric Evaluation of a Patient-Reported Symptom Index for Non-Muscle Invasive Bladder Cancer: Field Testing
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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)




Primary Outcome Measures :
  1. NMIBC-SI [ Time Frame: Field test 1: once only (cross-sectional). Field test 2: four time-points over 1 year (longitudinal) ]
    non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091764


Contacts
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Contact: Claudia Rutherford, PhD +61 2 8627 1583 claudia.rutherford@sydney.edu.au
Contact: Margaret-Ann Tait, MSc +61 2 8627 1558 margaret-ann.tait@sydney.edu.au

Locations
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United States, Kansas
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jeffrey M Holzbeierlein, MD, FACS         
Contact: Alexandra Dahlgren         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Resha Tejpaul         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Australia, New South Wales
Concord Hospital Recruiting
Concord, New South Wales, Australia, 2139
Contact    0297676789      
Royal North Shore Hospital Active, not recruiting
St Leonards, New South Wales, Australia, 2065
Riverina Cancer Care Centre Recruiting
Wagga Wagga, New South Wales, Australia, 2650
Contact: Mari Lashbrook         
The Urological Cancer Centre, Westmead Specialist Centre Recruiting
Westmead, New South Wales, Australia, 2145
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Mater Misericordiae Limited Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Denise Clark         
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Alfred Health Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Ashley Baring         
Monash Health Recruiting
Moorabbin, Victoria, Australia, 3189
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
New Zealand
Canterbury Urology Research Trust Recruiting
Christchurch, New Zealand, 8013
Contact: Liz Mitchell         
Tauranga Urology Research Recruiting
Tauranga, New Zealand, 3140
United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Salford, Manchester, United Kingdom, M5 5AP
Sponsors and Collaborators
University of Sydney
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Cancer Australia
Cancer Council New South Wales
Investigators
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Principal Investigator: Manish Patel, MBBS,PhD University of Sydney

Additional Information:

Publications:
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT03091764     History of Changes
Other Study ID Numbers: APP1103036
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sydney:
NMIBC
non-muscle invasive bladder cancer
Patient reported outcome
Symptom burden
Questionnaire
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases