This phase IV trial tests whether Bacille Calmette Guerin (BCG) solution can be given intravesically to non-muscle invasive bladder cancer (NMIBC) patients in their home and evaluates the effectiveness of a text message-based chatbot for helping patients manage their symptoms. The BCG solution is made from a weakened form of the bacteria Mycobacterium bovis (bacillus Calmette-Guerin) that does not cause disease but stimulates the body's immune system. A catheter is used to place the BCG solution into the bladder (intravesical) where it is held for about two hours. Intravesical BCG is approved for the treatment of patients with NMIBC. Patients in this study also engage with a text message-based chatbot, which provides symptom monitoring and self-management support, motivational reminders, and appointment reminders. Offering at-home BCG treatments, with the support of a chatbot, may increase compliance with recommended treatment and improve patient-reported outcomes in patients with NMIBC.
Additional locations may be listed on ClinicalTrials.gov for NCT07048496.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Daniel Lee
Phone: 215-614-4053
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of home delivery of BCG to improve compliance with guideline concordant care.
SECONDARY OBJECTIVES:
I. To determine if patients receiving home delivery of BCG will have higher satisfaction rates, lower financial toxicity scores, and reduced racial / ethnic disparities in BCG compliance rates.
II. Evaluate barriers and facilitators for receiving intravesical treatment for NMIBC in the clinic and at home using a mixed methods approach.
III. Evaluate the effect of a mobile based conversational agent (automated, algorithmic 2-way texting) on improving self-efficacy and symptom management by providing real-time patient reported outcomes.
OUTLINE: Participants are assigned to 1 of 2 cohorts.
COHORT 1: Participants complete surveys and an interview in support of refinement of the intervention for Cohort 2.
COHORT 2: Patients receive BCG intravesically at the urology clinic for their first treatment and then receive BCG intravesically in their home weekly for 5 additional treatments, for a total of 6 treatments over 6 weeks. Patients engage with the HomeBCG chatbot, which provides real-time symptom monitoring with self-management support, motivational reminders, and appointment reminders, starting at the baseline visit and continuing for 12 weeks on study. Patients also undergo cystoscopy with bladder biopsy during follow-up.
After completion of study treatment, patients in Cohort 2 are followed up at weeks 12 and 14.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorDaniel Lee
