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

Johns Hopkins University

Status: Enrolling

Conditions: Non-Muscle Invasive Bladder Cancer

Treatments: Other: Research Blood Draw; Other: Questionnaires; Other: Utilize excess tissue from a standard of care procedure; Other: Daily Mood Diaries; Other: Urine Specimen Collection

Study type: Observational

Funder types: Other

Identifiers

NCT05672615

IRB00306420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments

Description:

Participants who are receiving BCG intravesical treatments will be asked to provide research urine samples and blood samples prior to and during their treatment course. Participants will also be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale at the start and throughout the treatment course. Participants will be given a daily mood diary to complete at the following timepoints: 6-week induction treatment, 3-week maintenance treatment, and the 3-month follow-up. The study team will ask permission from participants to utilize excess tissue samples from standard of care procedures and biopsies. Participants' medical history and clinical data will also be collected for the study.

Treatment:

Other: Urine Specimen Collection

Other: Daily Mood Diaries

Other: Utilize excess tissue from a standard of care procedure

Other: Questionnaires

Other: Research Blood Draw

Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments

Description:

Participants who are receiving chemotherapy intravesical treatments will be asked to provide research urine samples and blood samples prior to and during their treatment course. Participants will also be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale at the start and throughout the treatment course. Participants will be given a daily mood diary to complete at the following timepoints: 6-week induction treatment, 3-week maintenance treatment, and the 3-month follow-up. The study team will ask permission from participants to utilize excess tissue samples from standard of care procedures and biopsies. Participants' medical history and clinical data will also be collected for the study.

Treatment:

Other: Urine Specimen Collection

Other: Daily Mood Diaries

Other: Utilize excess tissue from a standard of care procedure

Other: Questionnaires

Other: Research Blood Draw