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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05672615
• Other study ID #: IRB00306420
• Status: Recruiting
• Start date: March 21, 2023
• Est. completion date: March 2028

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: Riziki Covington
• Phone: 202-660-6133
• Email: rcoving5[@]jh.edu
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 2028
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Non-Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.
• 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

Country	Name	City	State
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cytokine response as assessed by urine samples	Collect urine samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment	Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months
Primary	Change in cytokine response as assessed by blood samples	Collect blood samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment	Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to the each 3-month follow-up cystoscopy
Primary	Screening for Mood Disorders utilizing the Zung Self Rating Depression Scale	Screen for mood disorders in patients diagnosed with Non-muscle Invasive Bladder Cancer at baseline and while undergoing treatment utilizing the Zung Self Rating Depression Scale. The Zung Self-Rating Depression Scale has the following score ranges: Normal Range (25-49), Mildly Depressed (50-59), Moderately Depressed (60-69), Severely Depressed (70 and above)	Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Secondary	Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale	Screen for mood disorders in patients diagnosed with Non-muscle Invasive Bladder Cancer at baseline and while undergoing treatment utilizing the Zung Self Rating Anxiety Scale	Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Secondary	Screening for Mood Disorders utilizing daily mood diaries	Screening for Mood Disorders at baseline and through the treatment course with daily mood diaries	Daily mood diary for 6-week induction intravesical treatment course, daily mood diary for 3-week intravesical treatment maintenance course, and daily mood diary between 3-month follow up cystoscopy appointments
Secondary	Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response	Collect blood and urine samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations and compare them with excess tissue from a clinically indicated procedure	Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy