Evaluating mood changes in bladder cancer patients treated with BCG
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
This study is trying to see how BCG treatment for bladder cancer affects the mood of patients by tracking their anxiety and depression levels during the therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT05672615 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess mood alterations in patients with Non-Muscle Invasive Bladder Cancer undergoing intravesical Bacillus Calmette-Guerin (BCG) treatment. Participants will provide blood and urine samples, complete questionnaires, and maintain daily mood diaries throughout their treatment course. The study will track changes in anxiety and depression levels using standardized scales before and during treatment. Data collected will help understand the psychological impact of BCG therapy on these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed Non-Muscle Invasive Bladder Cancer who are eligible for intravesical treatment.
Not a fit: Patients who are not candidates for intravesical treatment or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the psychological effects of BCG treatment, potentially leading to better support and management strategies for patients.
How similar studies have performed: While studies on mood alterations in cancer patients exist, this specific approach focusing on BCG treatment in bladder cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Armine Smith, MD — Johns Hopkins University
- Study coordinator: Domani Rodriguez
- Email: drodri59@jh.edu
- Phone: 2026605561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.