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

Non-Muscle Invasive Bladder Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical treatments are eligible to participate in this study. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each induction intravesical treatment. During the 6-week induction intravesical treatment, participants will also be given a daily mood dairy to complete. Urine Specimens will be collected prior to each induction intravesical treatment and at each 3-month cystoscopy appointment during the treatment course. An at home urine collection may occur 6 hours post intravesical treatment. Research Blood Samples will be collected prior to the first induction intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy as indicated by the participant's treatment course. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each 3-month follow-up cystoscopy during the treatment course. A 3-week daily mood diary will be completed by participants during the 3-week intravesical maintenance treatment. Participants will be given a daily mood diary to complete between the 3-month follow-up cystoscopy appointments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05672615
Study type Observational
Source Johns Hopkins University
Contact Riziki Covington
Phone 202-660-6133
Email rcoving5@jh.edu
Status Recruiting
Phase
Start date March 21, 2023
Completion date March 2028
View Details
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