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.
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
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
Subjects that are 18 years old or older who have pathologically confirmed non-muscle invasive bladder cancer. Subjects receiving intravesical treatments as part of their standard of care.
Cohort
Prospective
Questionnaires
Other interventionParticipants 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 interventionParticipants 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 interventionUrine 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 interventionBlood 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 interventionParticipants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.
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
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
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)
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
Screening for Mood Disorders utilizing daily mood diaries
Screening for Mood Disorders at baseline and through the treatment course with daily mood diaries
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
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