Evaluation of a Patient-Reported Symptom Index for NMIBC

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Field test 1:

Diagnosed Non-Muscle Invasive Bladder Cancer (NMIBC).
Adult (≥ 18 years).
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 (≥ 18 years).
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.

Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Stephen Boorjian, M.D.	Closed for enrollment	Contact information: Grant Dubbels B.S. (507)538-6151 Dubbels.Grant@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Boorjian, M.D.

Closed for enrollment

Contact information:

Grant Dubbels B.S.

(507)538-6151

Dubbels.Grant@mayo.edu

More information

Publications

Nonmuscle invasive bladder cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumor resections, and intravesical treatments that can occur every 3 months for life. In this clinical context, patient-reported outcomes (PROs) are a critical concern for patients and their managing clinicians. PROs have enormous potential to be integral to treatment assessment and recommendations for NMIBC; however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side effects associated with contemporary treatments. Read More on PubMed

Clinical Trials