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

Official title

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

Overview

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.

Detailed 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.

Interventions

• 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.
• Other 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.
• Other 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.
• Other 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.
• Other 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.

Primary outcome measures

• Change in cytokine response as assessed by urine samples [Time frame: Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months]
• Change in cytokine response as assessed by blood samples [Time frame: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to the each 3-month follow-up cystoscopy]
• Screening for Mood Disorders utilizing the Zung Self Rating Depression Scale [Time frame: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit]

Secondary outcome measures (3)

• Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale [Time frame: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit]
• Screening for Mood Disorders utilizing daily mood diaries [Time frame: 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]
• Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response [Time frame: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Sibley Memorial Hospital — Washington D.C.

Identifiers

NCT: NCT05672615 · IRB00306420

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗