Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
Johns Hopkins University
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- OtherQuestionnaires
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.
- OtherDaily 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.
- OtherUrine 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.
- OtherResearch 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.
- OtherUtilize excess tissue from a standard of care procedure
Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.
Location
- Sibley Memorial HospitalWashington D.C., District of Columbia