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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Johns Hopkins University
Study ID
NCT05672615
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Questionnaires — OTHER
    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 — OTHER
    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 — OTHER
    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 — OTHER
    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 — OTHER
    Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.

Study Details

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.

Key Dates

Start date
Mar 21, 2023
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
42 participants (estimated)

Arms

  • Arm: Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
    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.
  • Arm: Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
    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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Domani Rodriguez
[email protected]
202-660-5561
Armine Smith, MD
[email protected]
202-660-5561

Find similar trials in Washington D.C., DC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Sibley Memorial Hospital· Washington D.C., DC

Related Studies