Home-Based Outpatient Model for BCG Delivery to Reduce Undue Burden on Patients Undergoing Treatment for Non-Muscle Invasive Bladder Carcinoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07874347
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Non-Muscle Invasive Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCG Solution — BIOLOGICAL
    Given via installation in the bladder
  • Best Practice — OTHER
    Receive BCG in a hospital-based clinical setting
  • Cystoscopy — PROCEDURE
    Undergo cystoscopy
  • Home Health Encounter — OTHER
    Receive BCG installation at home by trained home health nurses
  • Survey Administration — OTHER
    Ancillary studies

Study Details

This phase I/II trial tests the feasibility of home based BCG delivery to reduce undue burden on patients undergoing treatment for non-muscle invasive bladder carcinoma. Bacillus Calmette Guerin (BCG) is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. For patients with bladder cancer it is used in a solution and placed directly into the bladder to stimulate the immune system to attack the cancer cells. Bladder cancer patients often face frequent clinic visits for BCG treatment, creating time, cost, and require help from caregivers or family members. BCG treatment may be able to be given at home which would improve access and quality of care without compromising treatment effectiveness for patients with non-muscle invasive bladder carcinoma.

Key Dates

First listed
Oct 14, 2026
Start date
Jan 15, 2027
Status verified
Oct 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Health services research (Home based BCG delivery)
    Patients receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo cystoscopy and patients with no cancer identified receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 3 weeks, starting 1-2 weeks post cystoscopy. The first installation is administered in a hospital-based clinical setting for initial observation, all subsequent treatments are delivered in the patient's home by trained home health nurses. Participants receive emergency contact information, including the telephone number for the 24-hour triage line and instructions for contacting the on-call urologist, to report any suspected exposure or treatment-related concerns.

Primary Outcome Measure

Successful administration of Bacille Calmette Guerin (BCG) therapy in at least four of five in-home induction doses (feasibility) [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Cheryl T. Lee, MD
[email protected]
614-293-4696
Cheryl T. Lee, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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