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Trial Title:
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
NCT ID:
NCT05672615
Condition:
Non-Muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Bacillus Calmette-Guerin
Mood Alterations
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Questionnaires
Description:
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.
Arm group label:
Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
Arm group label:
Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
Intervention type:
Other
Intervention name:
Daily Mood Diaries
Description:
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.
Arm group label:
Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
Arm group label:
Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
Intervention type:
Other
Intervention name:
Urine Specimen Collection
Description:
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.
Arm group label:
Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
Arm group label:
Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
Intervention type:
Other
Intervention name:
Research Blood Draw
Description:
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.
Arm group label:
Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
Arm group label:
Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
Intervention type:
Other
Intervention name:
Utilize excess tissue from a standard of care procedure
Description:
Participants may indicate permission to provide excess tissue from a clinically indicated
procedure for research purposes.
Arm group label:
Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
Arm group label:
Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Riziki Covington
Phone:
202-660-6133
Email:
rcoving5@jh.edu
Contact backup:
Last name:
Armine Smith, MD
Phone:
202-660-5561
Email:
asmit165@jhmi.edu
Start date:
March 21, 2023
Completion date:
March 2028
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05672615
