Clinical trial · Interventional
Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
NCT07048496CI-TRIAL-00111315BCG at HomerecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 proposed project will have two separate cohorts. The first will be to perform a more in-depth qualitative assessment of the barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer. The second arm will be to create and test a BCG at home program. Participants in the second cohort will be enrolled in a conversational agent to measure patient symptoms and quality of life and improve self-efficacy.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG delivery at home | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of adherence to BCG therapy at 3 months after study initiation
- timeFrame
- 3 months after study initiation
- description
- The primary outcome will be the rate of adherence to AUA guidelines for BCG therapy as measured by successful treatments of BCG compared to expected treatments. For each participant, adherence will be calculated both as the percentage of adherent doses, evaluable for study participants
Secondary outcomes (1)
- measure
- • Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation
- timeFrame
- 3 months after study initiation
- description
- The secondary outcomes will include self-efficacy and symptom management.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria for patients in Cohort 1 * Age 18 years or older; * completed intravesical treatment for non-muscle invasive bladder cancer within the past year Cohort 1 inclusion criteria for key stakeholders * Age 18 years or older; * experience with the delivery of BCG delivery for more than 2 years Cohort 2 inclusion criteria * Age 18 years or older; * diagnosed with non-muscle invasive bladder cancer and prescribed BCG for initial therapy Exclusion Criteria: Cohort 1 exclusion criteria • inability to provide informed consent Cohort 2 exclusion criteria * inability to provide informed consent * inability to undergo catheterization (i.e. - history of urethral stricture) * inability to receive BCG therapy (i.e. - previous reaction with BCG) * no access to mobile phone * inability to respond to written conversations in English
References
Publications (0)
Data not yet available
No reference posted for this study.