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Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Sponsor: Johns Hopkins University
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
Conditions
Interventions
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.
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.
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.
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.
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