Evaluation of a Patient-Reported Symptom Index for NMIBC

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-006074
    NCT ID: NCT03091764
    Sponsor Protocol Number: 17-006074

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Field test 1:

  • 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

Field test 2:

  • Diagnosed NMIBC
  • Adult (>18yrs)
  • Able to read and understand English
  • After imaging or flexible cystoscopy but before endoscopic resection (i.e. before active treatment)

Exclusion Criteria:

Field test 1:

  • 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:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Boorjian, M.D.

Open for enrollment

Contact information:

Kathryn Doty CCRP

(507)538-6151

Doty.Kathryn@mayo.edu

.
CLS-20357367

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