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 : May 14, 2020
|Condition or disease|
|Superficial Bladder Cancer|
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 [Patient Registry]|
|Estimated Enrollment :||450 participants|
|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, 2020|
|Estimated Study Completion Date :||June 30, 2021|
NMIBC Patient High Risk
Any of the following:
(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)
- 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)
- QLQC-30 [ Time Frame: Field test 2: four time-points over 1 year ]EORTC cancer quality of life questionnaire
- NMIBC24 [ Time Frame: Field test 2: four time-points over 1 year ]EORTC superficial bladder cancer questionnaire
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
|Contact: Claudia Rutherford, PhD||+61 2 8627 firstname.lastname@example.org|
|Contact: Margaret-Ann Tait, MSc||+61 2 8627 email@example.com|
|Principal Investigator:||Manish Patel, MBBS,PhD||University of Sydney|