Evaluation of a Patient-Reported Symptom Index for NMIBC

University of Sydney

Status: Completed

Conditions: Superficial Bladder Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03091764

APP1103036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 498 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

498 participants in 3 patient groups

NMIBC Patient High Risk

Description:

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

Description:

All cases between High and Low Risk (Patients requiring intravesical therapy which lasts between 6 weeks to 3 years)

NMIBC Patient Low Risk

Description:

Primary, solitary, Ta, LG/G1, \<3cm, no CIS (Patients receiving frequent cystoscopies, possible tumour resections and single instillations of postoperative chemotherapy)