Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
Johns Hopkins University
42 participants
Mar 21, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Subjects with a pathologically confirmed non-muscle invasive bladder cancer
- Age ≥ 18 years old
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria2
- Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment.
- Patients who are pregnant
Interventions
Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.
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.
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 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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05672615