Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support

Not Applicable

Not yet recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT07048496
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-05-06
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Study Start: 2025-07-05
• Primary Completion: 2026-08-05
• Study Completion: 2026-09-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of adherence to BCG therapy at 3 months after study initiation	3 months after study initiation	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 Outcome Measures

Name	Time	Method
• Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation	3 months after study initiation	The secondary outcomes will include self-efficacy and symptom management.