Home Intravesical Treatment for Bladder Cancer

(BCG at Home Trial)

Overseen By Daniel Lee, PI, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: BCG

Disqualifiers: Informed consent, Catheterization, BCG reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve bladder cancer treatment by examining how people manage their therapy at home. It focuses on two groups: one to identify factors that help or hinder adherence to treatment, and another to test a home-based bladder cancer treatment program. The trial includes individuals who have recently undergone bladder cancer treatment or are beginning a specific treatment (BCG therapy, a type of immunotherapy) for non-muscle invasive bladder cancer. Participants must be able to use a mobile phone and communicate in English. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future home-based cancer therapies.

What prior data suggests that this home treatment program is safe for bladder cancer patients?

Research has shown that receiving bladder cancer treatment at home is generally safe and well-tolerated. Studies have found that using mitomycin, a type of chemotherapy, at home for non-muscle invasive bladder cancer reduces the need for frequent clinic visits and conserves medical resources. This allows patients to receive treatment at home without frequent clinic trips.

Another study suggested that receiving chemotherapy at home may be as safe and comfortable as in a clinic. It also appears to be a convenient option, potentially reducing stress during the treatment process.

For Bacillus Calmette-Guerin (BCG), a common bladder cancer treatment, research indicates a lower risk of immune-related side effects compared to some other treatments. However, using antibiotics with BCG might increase the risk of these side effects.

Overall, these findings suggest that home-based treatments for bladder cancer can be safe, making them a viable option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home intravesical treatment for bladder cancer because it offers a novel delivery method that allows patients to administer therapy at home. Unlike traditional treatments that require frequent hospital visits for catheter-based drug delivery, this approach could significantly improve convenience and quality of life. Additionally, it may reduce healthcare costs and hospital resource use, making it an appealing alternative to standard care options.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-muscle invasive bladder cancer needing initial BCG therapy. It's not for those who can't consent, have catheterization issues like urethral strictures, had bad reactions to BCG before, or lack a mobile phone and English literacy.

Inclusion Criteria

I am 18 or older with early-stage bladder cancer and prescribed BCG therapy.

I am over 18 and have worked with BCG delivery for more than 2 years.

I am 18 or older and finished bladder cancer treatment within the last year.

Exclusion Criteria

I cannot give informed consent.

Cohort 2: 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Assessment

In-depth qualitative assessment of barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer

3 months

BCG Treatment at Home

Participants receive BCG treatment at home and are enrolled in a conversational agent to measure patient symptoms and quality of life

3 months

Follow-up

Participants are monitored for self-efficacy and symptom management

3 months

What Are the Treatments Tested in This Trial?

Trial Overview The study has two parts: one explores barriers to treatment compliance in bladder cancer care; the other tests at-home BCG treatment supported by a conversational agent tracking symptoms and life quality to boost self-management.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07048496

Intravesical Treatment of Bladder Cancer at Home, Multi ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

2. urologytimes.com urologytimes.com/view/home-instillation-of-mitomycin-intravesical-solution-found-feasible-safe-in-nmibc

Home instillation of mitomycin intravesical solution found ... Home administration of mitomycin for LG-IR-NMIBC is feasible, safe, and effective, potentially reducing patient burden and clinical resource ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2024-09555

In-home Intravesical Chemotherapy for the Treatment of ... In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20578929

In-home Intravesical Chemotherapy For The Treatment Of ... The purpose of this study is to evaluate the feasibility and safety of in-home delivery of intravesical therapy for bladder cancer, as well as its impact on ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11572315/

Safety profiles of intravesical Bacillus Calmette-Guerin in ... Intravesical BCG exhibited lower immune-related AEs (irAEs) risk than anti-PD-1/PD-L1 treatment, but antibiotics increased the risk.