Evaluation of a Patient-Reported Symptom Index for NMIBC
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | July 1, 2016 |
| End Date: | June 30, 2020 |
| Contact: | Claudia Rutherford, PhD |
| Email: | claudia.rutherford@sydney.edu.au |
| Phone: | +61 2 8627 1583 |
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.
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.
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.
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.
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.
We found this trial at
4
sites
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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