Nonmuscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of the over 83,000 new bladder cancer cases diagnosed annually, and there are over 700,000 individuals living with bladder cancer in the United States.¹ Progression of NMIBC is associated with significant morbidity and mortality and more than doubles health care costs.² The mainstay of therapy to help reduce the risks of recurrence and progression is intravesical therapy, either bacillus Calmette-Guérin (BCG) or chemotherapy.

Yet despite known efficacy and guideline support for using intravesical therapy in NMIBC, use rates remain lower than desired. In the United States, less than two-thirds of patients receive adequate induction BCG, and only one-quarter receive maintenance BCG.³ Even in clinical trial settings, intravesical therapy is discontinued at rates higher than expected from adverse events alone.⁴ Although reasons for this are multifactorial, there is evidence that the time toxicity of intravesical therapy is a meaningful barrier for some NMIBC patients in receiving guideline-concordant care.

Time toxicity is defined as the time spent both coordinating and receiving cancer treatment in a health care facility, including time for travel, wait times, seeking unscheduled care for side effects, and time for follow-up tests.⁵ For some patients, time toxicity may be substantial enough to offset potential therapeutic gains. This may be particularly true among patients with NMIBC, who are often elderly with multiple comorbidities and are asked to make up to 19 urology visits in the first year after diagnosis for treatment and surveillance.

We recently performed a survey among bladder cancer survivors to characterize the treatment burden they experienced in receiving intravesical therapy.⁶ Over half of respondents reported a one-way travel time exceeding 30 minutes, and one-third spent over $25 out of pocket per trip, not adjusting for inflation, which can add up quickly for patients on a fixed income (Figure 1).⁶ Additionally, more than half of patients reported that a single treatment lasted over 2 hours, and one-third missed work for each treatment. Lost wages are known to contribute significantly to the financial toxicity of NMIBC and can result in delays in care.⁷ The cumulative effect is a substantial burden of treatment for patients undergoing intravesical therapy, and the expectation that our patients will travel to a medical facility for every treatment not only overlooks the time toxicity of therapy but may also exacerbate existing health disparities among those in rural geography or with lower incomes and among racial/ethnic minorities.⁸

In-home delivery of intravesical therapy is one potential solution that may help reduce time toxicity and improve the patient experience of NMIBC care. We believe that the postpandemic paradigm shift toward increasing telehealth and remote care in urology presents a prime opportunity to rethink the process of care delivery for intravesical therapy, which remains effectively the same as when intravesical BCG was introduced in 1976.⁹ In our aforementioned survey study, 72% of respondents reported openness to receiving in-home intravesical therapy, and many patients cited potential benefits, including reduced anxiety around receiving treatments, supporting the development of such an approach.⁶

To evaluate this hypothesis, we are conducting the phase 2, single-arm, In-Home Intravesical Therapy (INVITE) trial, which will enroll patients receiving intravesical therapy for NMIBC to receive treatments delivered in their homes through a network of contracted home care nurses (Figure 2). Patients receiving induction therapy with either BCG or intravesical chemotherapy will receive their first treatment in the brick-and-mortar clinic to ensure safety and tolerability, with doses 2 to 6 delivered in their home, and patients receiving maintenance therapy will receive all 3 scheduled doses at home. The primary outcome is the feasibility of delivering in-home intravesical therapy, with a key secondary outcome of patient satisfaction and likelihood to recommend in-home therapy. Additional secondary outcomes include patient safety, health-related quality of life, number of home days without physical health care system contact during the study period, and number of unscheduled interactions with the urology care team during treatment.

Several operational challenges need to be overcome to implement in-home intravesical therapy successfully.¹⁰ Reconstituted BCG should be refrigerated and used within 2 hours, which impedes transport outside of a pharmacy. However, closed-system transfer devices can safely transport BCG prior to reconstitution, with subsequent reconstitution within a sterile system while in the patient’s home, effectively overcoming this barrier.¹¹ Widespread implementation beyond the trial setting will require an adequate infrastructure of resource pharmacies and home care delivery providers to help reach patients where they are. Thankfully, several existing companies market their services to interested health care systems to help navigate the logistics of in-home treatment delivery, and more entrants to this market are expected in the near future. Reimbursement models for in-home treatment that ensure the financial viability of this approach will also need to be negotiated. Patient cost-sharing could be considered; notably, in our survey, one-quarter of respondents reported willingness to pay an additional out-of-pocket fee beyond their traditional copays for the added convenience of receiving treatment in the home.⁶

In conclusion, in-home intravesical therapy has the potential to decrease time toxicity of therapy and improve patient satisfaction and compliance with treatment, and we look forward to generating data to inform the feasibility of this approach. We owe it to our patients to develop and test innovative care delivery methods to help improve the patient experience of bladder cancer care.