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Ruchika Talwar: Hi everyone and welcome back to UroToday's Health Policy Center of Excellence. My name is Ruchika Talwar. I'm joined today by Dr. Amanda Myers, who is a urologic oncology fellow at MD Anderson Cancer Center. She's with us today discussing her important work on at-home intravesical therapy. Thank you so much for being here with us.

Amanda Myers: Thank you so much for having me today. I'm really excited to discuss this work. It is really important to me, and I'm glad we had this opportunity. So, our study is titled 'Patient-Reported Treatment Burden and Attitudes Towards In-Home Intravesical Therapy Among Patients with Bladder Cancer.' And this study was essentially inspired by a patient's voice and desire for an easier way to receive their treatment for non-muscle invasive bladder cancer. As you know, a lot of bladder cancer patients have mobility issues, comorbidities that can make it difficult to frequent the clinic, and intravesical therapy is very time-intensive for induction. You need to come six weeks in a row, and it's not always widely available, and a lot of patients travel long distances to receive care at our clinic and have access to intravesical therapy. So, we thought, would it be possible to deliver BCG in a way where we could bring it to the patient and have it delivered in their home?

However, before we could do that, we needed to figure out exactly what the burden that patients were facing was and then also see if this is something that would be interesting to patients. And thus, we did a cross-sectional survey of the BCAN Patient Survey Network in November 2021, of which we had 233 respondents with a median age of 70 years old, who had received at least one dose of intravesical therapy. Actually, 66% had received greater than 12 treatments, and this was over a time span from 1991 to 2021. And from our findings of the treatment burden, what we really wanted to focus on was these two findings, which was the travel time and the out-of-pocket cost. I think these are super important to highlight that the travel time greater than 30 minutes was reported by over half of patients, and this is just one way for one treatment.

Also, about a third of patients reported an out-of-pocket cost greater than $25 per trip, not counting for inflation. And the treatment burden really extends beyond just time and money. And you can see here we have a table highlighting the patient-reported treatment burden. I think other than time and money, really missing work is a significant financial impact reported by 36% of patients, and those who did miss work missed at least half a day of work. Moreover, over 56% of patients had a caregiver come to their appointment, which is another person involved in this treatment burden. And half the patients reported spending more than two hours on each treatment with 18% spending more than four hours. Also, just even here you can see the process actually affected their ability to do their daily activities and 26% of patients were significantly impacted.

Encouragingly, there was actually 72% of patients that were open to receiving in-home intravesical installations, including 44% of respondents who said yes, and 28 percent who responded maybe or were unsure that they would like to receive these treatments. The patient's views are summarized here, and in general, patients felt that they would have more privacy and that the treatment would be less disruptive to their lives. The overwhelming majority felt safe having medications brought into their home and 27% reported that their anxiety would be reduced, although there were some safety concerns in 11% of patients, and 37% preferred the clinic.

This really highlights the need for patient education. There is actually a study out of University of Pennsylvania looking at intravenous chemotherapy during the pandemic being delivered at home. And patients tended in that study, patients really tended to go with their doctor's advice or to want to have the status quo or the normal treatment. So I think that there is room for even more patients to be open to in-home treatments with education from their treating physicians. I will say that this survey of the BCAN Patient Survey Network is involving highly engaged patients and it may not be applicable or generalizable to all patients receiving intravesical treatment. And the study was based on patient recall and their reported experiences were from a long time range of over almost 30 years. And those may not reflect the exact burdens that patients are facing today. However, overall, the treatment burden is there, and we know it.

We can see it in their travel time, their out-of-pocket costs, and their need for caregiver support. And the message here is really that we need to have innovative care delivery processes to reduce the treatment burden for our bladder cancer patients. And we need to think of novel treatments, but also novel treatment mechanisms to support patient-centered care. I also wanted to just add that we're really thankful for all the patients who participated and our supporters at BCAN and beyond who made this work possible, and we're really aiming to continue to explore the treatment burden of non-muscle invasive bladder cancer and identify actionable changes for improved care delivery.

Ruchika Talwar: Great. Thank you, Dr. Myers. It's a really interesting study and I think you bring up several important points that I'd like to dig into a bit. First of all, you highlight the fact that patients have significant barriers to obtaining once weekly for six weeks induction intravesical therapy, not mentioning that down the line, there's often also additional maintenance intravesical chemotherapy needed. So, I think it is important to note that outside of the time that they're physically spending in the clinic, they need to drive to your center. A lot of times, when there's a BCG shortage, the closest center may not necessarily be the one they're driving to.

They may have to, especially patients in rural areas, may have to travel really far distances. So, the idea of at-home intravesical therapy can really help alleviate some of that time burden, thereby also in some capacity potentially alleviate the time that the patient or the caregiver spends outside of work. So, that's one important point you bring up. The other thing to note is also that there was some hesitation to in-home intravesical therapy, and I just wanted to sort of pick your brain on that. What are your thoughts? What do you think the reason behind some of that is?

Amanda Myers: I think the reason that some patients are hesitant is the thought of bringing medications into their home. They may have other people living in their home; they don't want to expose them to certain medications. They don't know what the disposal of those medications process would be. They may feel uncomfortable having someone catheterize them in their home or may not want to be a burden on their family.

Ruchika Talwar: Yeah, those are all great points. I think those certainly could be within the realm of possibility for some hesitation. I think another thing that we're going to notice over time is as we move towards this hospital at home model where a lot of people are actually discharging long-term patients from facilities to build some of those resources at home as well as home nursing, home wound care, a lot of our resources are shifting to try to open up inpatient beds and to keep people out of the hospital. As that trend continues, I think patients will start to become more and more comfortable with the idea of having these sorts of procedures like catheterization or treatments like intravesical therapy at home. And I know that you mentioned your population spanned up to 30 years prior to having their diagnosis of bladder cancer. So, things certainly have changed, especially post-pandemic. How has this information changed the way you perhaps counsel or discuss intravesical therapy with your patients?

Amanda Myers: So, I think you bring up a really good point about the decentralization of healthcare and how it's increasingly delivered. Less so in the hospital and less so in the clinic and more so we're treating patients at home, and they're becoming more comfortable and actually embracing and liking the idea of not having to travel to the clinic and not having to receive their treatments in a hospital setting. I think that in terms of how I would counsel my patients, is, I, at this point, what I would really counsel them on is that we're actually going to be trialing these medications in patients' homes. And we believe these medications are safe. There are a lot of regulatory rules regarding safe transport of different classes of medications in healthcare settings. And these even vary from state to state.

Ruchika Talwar: Yeah, that's a good point.

Amanda Myers: So, explaining that to patients, explaining to them that we have appropriately trained personnel to handle and deliver their treatments wherever they're getting them, would be really important points to focus on.

Ruchika Talwar: Absolutely, I think right now, obviously, we have a long way to go before this becomes widely implemented, but I think just even bringing up the idea for eligible patients at centers like yours and other big centers that have the infrastructure to support this kind of work, it really, I think, is going to be the forefront of how we transition patients to getting more efficient intravesical therapies, in addition to things like at-home IV chemotherapy as well. Like you mentioned, the study out from the University of Pennsylvania. I just think as time goes on, our resources are becoming more and more strained, and we're going to be trying our best to keep patients out of the clinic, out of the hospital, and really in the comfort of their own homes. So, I think this is an important study in understanding the patient's perspective, if they'd be open to it, and what potential barriers that we may face during implementation. So, congratulations on this important work.

Amanda Myers: Thank you so much. I would add that one of the next steps is really also engaging payers in how we would reimburse for this treatment delivery mechanism as care is shifting more into the home setting. And we actually, to that end of what you were just saying, we're actually having a forthcoming phase two single-arm in-home intravesical therapy trial. This is the INVITE trial, and it will assess the feasibility and patient preference for in-home intravesical instillations. And at present, we don't have the protocol details to share, but that will be disseminated through clinicaltrials.gov in the near future.

Ruchika Talwar: Great. Well, we look forward to the upcoming trial data. We'll certainly have you back to discuss that because I think it'll really shape the way that we treat our non-muscle invasive bladder cancer patients moving forward. Thank you for joining us tonight, and we look forward to hearing more about what you have in store.

Amanda Myers: Thank you again. It's been great.

Ruchika Talwar: To our audience, we'll see you next time.