Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Riziki Covington
rcoving5@jh.edu
202-660-6133
Backup
Armine Smith, MD
asmit165@jhmi.edu
202-660-5561
Time Frame
Start Date:2023-03-21
Estimated Completion Date:2028-09
Participants
Target number of participants:42
Treatments
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.
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.