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

NCT07048496 | Recruiting

• 2 other identifiers: UPCC 04823IRB number 23-0460
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 months after study initiation

Secondary Outcomes (1)

• • 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

Interventions

BCG delivery at home OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older;
• Age 18 years or older;
• experience with the delivery of BCG delivery for more than 2 years
• Age 18 years or older;
• diagnosed with non-muscle invasive bladder cancer and prescribed BCG for initial therapy

You may not qualify if:

• inability to provide informed consent
• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Blue Cross Blue Shield: collaborator

Study Sites (1)

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Daniel Lee, PI, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: July 2, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)