Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

University of Kansas
Kansas City, Kansas 66160
Contact:
Jeffrey M Holzbeierlein, MD, FACS

More Details

Status
Recruiting
Sponsor
University of Sydney

Study Contact

Claudia Rutherford, PhD
+61 2 8627 1583
claudia.rutherford@sydney.edu.au

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.