Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of adherence to BCG therapy at 3 months after study initiation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy 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
Outcomes
Primary Outcomes
Rate of adherence to BCG therapy at 3 months after study initiation
Time Frame: 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 Outcomes
- • 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)
Investigators
Daniel Lee, MD, MS
Principal Investigator
University of Pennsylvania