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

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Other: BCG delivery at home

Study type: Interventional

Funder types: Other

Identifiers

NCT07048496

IRB number 23-0460 (Other Identifier)

UPCC 04823 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)