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RECRUITING
NCT05672615

Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.

Official title: Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

42

Start Date

2023-03-21

Completion Date

2028-03

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

OTHER

Questionnaires

Participants will be given the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale to complete prior to each induction intravesical treatment and prior to 3-month follow-up appointments.

OTHER

Daily Mood Diaries

Participants will be given daily mood diaries to complete during their 6-week induction intravesical treatment, 3-week maintenance treatment course, and between 3-month follow-up appointments.

OTHER

Urine Specimen Collection

Urine collections from patients will occur prior to each induction intravesical treatment and at 3-month follow-up cystoscopy appointments. An at home urine collection may occur 6 hours post intravesical treatment.

OTHER

Research Blood Draw

Blood collections will occur prior to first intravesical treatment, prior to fourth intravesical treatment, and each 3-month cystoscopy as indicated by the participant's treatment course.

OTHER

Utilize excess tissue from a standard of care procedure

Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.

Locations (1)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States