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RecruitingInterventional

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

NCT ID: NCT07048496Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2026-05-13

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.

Arms & interventions

  • OtherBCG delivery at home

    The BCG at home project will be a single-arm prospective pilot, to evaluate the feasibility, scalability and effectiveness of home treatment, and utilize the BB-Bot (chatbot) for PRO and adverse event measurement.

Outcome measures

Primary

  • Rate of adherence to BCG therapy at 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

    Time frame: 3 months after study initiation

Secondary

  • • Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation

    Time frame: 3 months after study initiation

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Recruiting
Daniel J Lee, MD, MS · Contact