RecruitingNCT05672615

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

Sponsor

Johns Hopkins University

Enrollment

42 participants

Start Date

Mar 21, 2023

Study Type

OBSERVATIONAL

Conditions

Non Muscle Invasive Bladder Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether BCG (Bacillus Calmette-Guérin) — a bacteria-based treatment instilled into the bladder to prevent bladder cancer recurrence — causes mood changes such as depression or anxiety in patients with non-muscle invasive bladder cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-muscle invasive bladder cancer confirmed by tissue analysis - You are scheduled to receive intravesical (into the bladder) BCG treatment - You are able to provide written informed consent **You may NOT be eligible if...** - You are not a candidate for intravesical treatment due to the nature of your disease (e.g., variant histology or progressive disease after prior intravesical treatment) - You are pregnant - You have a condition that would prevent participation in mood assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERQuestionnaires

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.

OTHERDaily 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.

OTHERUrine 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.

OTHERResearch 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.

OTHERUtilize 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

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NCT05672615

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