Recruiting

BCG at Home

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07048496

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BCG delivery at home

Study Details

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.

Conditions

Bladder Cancer

Study ID

NCT07048496

Start date

Jul 5, 2025

Status verified date

May, 2026

Completion date

Sep 5, 2026

Anticipated

Primary completion date

Aug 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

BCG 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.

Primary outcome measure

  • Rate of adherence to BCG therapy at 3 months after study initiation [ Time Frame: 3 months after study initiation ]

Central Contacts and Locations

Central contacts

Daniel Lee, PI, MD

215-615-3780daniel.lee4@pennmedicine.upenn.edu

Locations

Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Daniel J Lee, MD, MS

215-662-2891Daniel.Lee4@pennmedicine.upenn.edu

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-05-13.