Clinical trial · Observational
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily Mood Diaries | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| Research Blood Draw | Other | — | UNRESOLVED |
| Urine Specimen Collection | Other | — | UNRESOLVED |
| Utilize excess tissue from a standard of care procedure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
- description
- 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.
- interventionNames
- Other: Questionnaires
- Other: Daily Mood Diaries
- Other: Urine Specimen Collection
- Other: Research Blood Draw
- Other: Utilize excess tissue from a standard of care procedure
- label
- Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available