At-home BCG treatment with digital support for bladder cancer
Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
NA · Abramson Cancer Center at Penn Medicine · NCT07048496
This will try giving BCG at home plus a conversational app for adults with non‑muscle invasive bladder cancer to track symptoms and help them stick with treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07048496 on ClinicalTrials.gov |
What this trial studies
The project has two cohorts: a qualitative arm that interviews patients and stakeholders about barriers and facilitators to intravesical treatment adherence, and a pilot arm that creates and tests an at‑home BCG delivery program. Pilot participants receive home-based intravesical BCG under a protocol and use a conversational agent on their mobile phone to report symptoms, quality of life, and receive self‑management support. The qualitative cohort includes adults who completed intravesical therapy or experienced providers to inform program design, while the pilot cohort enrolls adults newly prescribed BCG who can undergo catheterization and use English-language mobile messaging. Procedures are managed through Abramson Cancer Center with remote monitoring and scheduled clinic oversight to track safety and adherence.
Who should consider this trial
Good fit: Adults with non‑muscle invasive bladder cancer who have been prescribed intravesical BCG, can undergo catheterization, have access to a mobile phone, and can interact in English.
Not a fit: Patients who cannot provide consent, cannot undergo catheterization, had prior severe reactions to BCG, lack a mobile phone, or cannot read English are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could make BCG treatment more convenient, improve adherence and symptom monitoring, and reduce clinic visits without compromising care.
How similar studies have performed: BCG is an established therapy for NMIBC, but home delivery of BCG and the use of conversational agents for this purpose are novel with limited prior pilot data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Abramson Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Daniel Lee, PI, MD
- Email: daniel.lee4@pennmedicine.upenn.edu
- Phone: 215-615-3780
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.
Conditions: Bladder Cancer