Table 4.
Stakeholder-reported facilitators of cancer clinical trial enrollmenta
| Facilitator | Subtheme | Example quotes | No. of times referenced |
|---|---|---|---|
| Institute a screening process | Provide streamlined care for the patients, such as between pediatric and medical oncologist or physicians in different subspecialties | “But actually their care is fragmented and they are not getting in trials is kind of a symptom of a bigger problem and we need to work on figuring out how we’re going to do care for AYAs better and whatever we figure out to do that then is where you introduce your clinical research.” (Male, 55-64 years, NCORP Site PI) | 35 |
| Improve communication and collaboration between providers and departments | “That depends on the site you’re at and the physicians you’re dealing with. Some sites have a weekly huddles with the physicians to discuss open trials and what’s available. They may also look at the upcoming week of schedules and see what patients are coming in and what might be available for them.” (Female, 55-64 years, NCORP Administrator) | ||
| Develop a system or have a designated individual to identify or flag potentially eligible AYAs | “We talked to almost every new referral from a clinical trials perspective right when they were diagnosed. … That was a lot of information for patients, but I think that was pretty successful, but I don’t know that you see that number of staff and a lot of facilities anymore.” (Female, 45-54 years, Nurse Navigator) | ||
| Have a prepared list of available, open studies | “If we could come up with a listing of our studies that kind of have the gap, meaning, some of our studies go up to like twenty-six or twenty-three type of thing. Where we could then make a listing maybe and supply that to the research coordinators and the nurses who do the screening on the adult side just to kind of keep it in their mind.” (Female, 45-54 years, CRA/CRN) | ||
| Leverage existing technology to alert staff and physicians that a patient may be eligible for an AYA trial | “If our EMR was a little bit better, and it’s theoretically supposed to be working towards doing this to be able to flag for us potentially relevant clinical trials, I think that would be good.” (Female, 35-44 years, Physician involved with enrollment) | ||
| Community and staff education | Collaborative efforts in developing AYA educational materials | “The optimal step would be to say hey here’s what we’ve created by working together with our oncologist, pediatric community, and we would be happy to make this available to help you guys develop a similar mechanism in your community with you.” (Male, 55-64 years, NCORP Site PI) | 26 |
| Educate staff about the AYA enrollment disparity, the importance of the AYA population and available trials | “Just keeping, maybe, informed with the research department, having them keep me up-to-date. Maybe go to research meetings to make sure I’m aware of what’s available because then I might be able to point out to a patient to them that might be eligible for an open clinical trial.” (Female, 45-54 years, Nurse Navigator) | ||
| Cross-training nurses and other staff in both the pediatric and medical oncology processes because AYA patients often overlap these departments | “I think we will here in the near future if we can get our adult area of staff, more and I can work with one of the nurses to cross train, and we definitely think that will be a possibility to capturing more of that age group from 21… maybe all of us should learn a little bit of everything, like all the protocols, but then there is so many that it’s hard to keep the adults and pediatrics straight. But, yeah, if we just had more training.” (Female, 45-54 years, RRA) | ||
| Direct patient education or communication | “Patient education is what I’m trying to promote.” (Female, 45-54 years, Nurse Navigator) | ||
| Provide educational resources for and opportunities to educate the broader community about clinical trials and available protocols | “I think just further reaching out to the community that even for kind of common diseases like Hodgkin’s, there are protocols… To make community education and possibly even more at the sites we have.” (Female, 55-64 years, Physician involved with enrollment) | ||
| Physician endorsement | Patients value their provider’s opinions and when physicians feel positively about a clinical trial being the best treatment option, patients are more likely to enroll | “I truly believe that physician endorsement of clinical trials, that that’s presented in a positive light from the physician, I think that makes those, those—I just believe that that’s the key.” (Female, 55-64 years, CRA/CRN) | 19 |
| Making physicians aware of the AYA population and available trials | “I think a lot of it goes back to your oncologist knowing what’s available and kind of being very proactive.” (Female, 45-54 years, Nurse Navigator) | ||
| Physicians need to deem that the site has the appropriate AYA population available to enroll in open studies | “Most of the trials that we set up here are ones that are kind of guided by the physicians themselves. We get all kinds of trials that we consider opening here, but the physicians themselves decide which ones are a good fit, which ones we have the population for … if you have a population where there’s need for it they’re the ones that finds them.” (Female, 55-64 years, CRA/CRN) | ||
| AYA enrollment would improve when providers are invested in research | “The best thing about our pediatric oncology providers is that they are all deeply interested in research, and so they understand that patients that are enrolled in clinical trials typically with have [on average] better outcomes.” (Female, 35-44 years, CRA/CRN) | ||
| Incentivize enrollment | Help AYAs navigate the process of being diagnosed with cancer and while undergoing treatment, which may include providing free or low-cost treatment options and resources | “I think it would be great to have someone who’s knowledgeable across all insurance aspects … but sometimes I think to have somebody that’s more knowledgeable about insurance coverage, what financial means are out there. Because a lot of these kids, this young population with their young families, their college debt, they’re brand new homeowners, financially how do we advise these patients?” (Female, 45-54 years, Nurse Navigator) | 21 |
| Provide NCORP credits for AYA enrollments | “I think credits is probably the thing that would get the most out of it. That seems to be the thing that NCORPs are basically focusing on because that’s how we’re judged, is the number of credits that you get. So I think credits is the big thing.” (Female, 55-64 years, NCORP Administrator) | ||
| Create incentives for specifically enrolling AYAs | “From the NCI, I don’t necessarily think there’s any incentive to specifically target the AYA population.” (Male, 35-44 years, NCORP Administrator) | ||
| Emphasize the benefit of participating in clinical trials to AYAs | “I think it really gets back to the ability to give back to the oncology community, give back to others who are going through the same thing.” (Male, 25-34 years, Patient Advocate) | ||
| Increase site reimbursement for enrollment | “We do not get enough reimbursement in order to cover the cost of the time for our research associate for the oncology piece One of the things that we’ve used to incentivize them to keep the program going is our ability to be certified on a higher level from the American College of Surgeons reviews, and so we’ve managed to do that. We’ve actually surprisingly enough been able to get accommodations for our research enrollment.” (Female, 55-64 years, Physician involved with enrollment) | ||
| Departmental collaboration | Required participation by NCORP members in studies | “We don’t have very much interaction and they have been serially resistant to joining the NCORP and we have not been able to figure out why. … I think maybe it’s just a basic inertia that this is working well and we don’t have to change anything and we don’t want to change anything.” (Female, 65-74 years, NCORP Site PI) | 15 |
| Participate in AYA-specific clinics or tumor boards | “We are looking at having an AYA clinic where we have requested that their medical oncologist at least provide us with one or two providers so that we can run a joint clinic, where we will see the AYA patients there.” (Male, 45-54 years, Physician involved with enrollment) | ||
| Improve relationships between pediatric oncology and medical oncology departments | “I realized that other institutions might not have the setup that we have here, how close peds and adult set. But I say it’s really great if you can form some sort of conversations or even if it’s a panel that you guys meet every few months to showcase what’s available on either side.” (Female, 35-44 years, Patient Advocate) | ||
| Updated communication methods | Communicate to AYAs about clinical trials in a developmentally appropriate manner | “Well, I always think I’m not presenting it as here’s this great option and here’s your other option. It just, here’s what standard is, here’s what you can do. We have this clinical trial that’s available. Here’s the difference and why we want to know about this or what we’ve seen be successful. And AYAs really want that autonomy. They want that—they want to be part of their, their decision making.” (Female, 35-44 years, Patient Advocate) | 13 |
| Tailor communication to AYAs as peer to peer | “Conversation…I’m not making the choices for them, but having conversations and having people who really understand these on the provider side and then on the patient side, people who…really want to listen and want to be a part of their treatment options and know what’s available. I think the biggest thing that get people to enroll is that conversation, giving them time to talk about it and talk about their fears and talking about what the benefits are and trying to be as objective as possible with that, but just letting them know what’s out there.” (Female, 35-44 years, Patient Advocate) | ||
| Creating email management lists to better distribute information among providers | “We’ve upgraded all of our AV devices for the meeting, as well as build a pretty big listserv of people who we want to get patient perception on this. … We can mass blast based on different demographics, different age, different payer mix, all of those variables are already listed in that serv. … We are starting to explore how to further and continually engage people.” (Male, 25-34 years, Patient Advocate) | ||
| Communicate about trials in ways the AYA population understands and prefers | “We felt like emailing was better or if we could get a cell phone number, we could not even like leaving a message on the cell phone, but if we would like text them or something like that, that seemed to work. So I felt like that was a little bit different than what I had seen before with the general population.” (Female, 35-44 years, CRA/CRN) | ||
| More AYA trials | Open more trials for diseases commonly affecting AYA population | “Well, I think my first step would be making sure that I had studies open in diseases that are more likely to affect an AYA…” (Female, 45-54 years, NCORP Site PI) | 11 |
| Expand study eligibility criteria and develop easier or more feasible study designs for this population | “Availability of decent doable studies. … It’s studies that I think are not going to put a young person through more procedures than they would, otherwise, normally have, or try to minimize that as much as possible to still get the answer to a legitimate scientific question.” (Female, 45-54 years, NCORP Site PI) | ||
| Design studies specifically with the AYA population in mind | “I think we need to continue to be very determined to find the kinds of studies that meet the needs and offer options of care for our patients. … It’s kind of exciting, we have some younger physicians and they’re very excited about the options of research and it’s nice to see them step up and really become some leaders in that and that’s exciting to see.” (Female, 55-64 years, CRA/CRN) | ||
| Simplify interaction with COG | Allow clinical trial participation by providers not involved in COG, as well as easier access to COG trials | “I’m through COG and other providers need to be registered with COG, and that in of itself is a very cumbersome process. So it’s my understanding that if an adult provider wants to participate in the COG study, they have to join COG. … So that process is very cumbersome. And so I think that limits us in some aspects because the providers have to take time to do that and then they have to renew it every single year and anyway, so that’s a process in [and] of itself. But if the provider is interested in the study, then the provider will be registered with COG there and then their team, CRN will also have a membership to COG.” (Female, 35-44 years, CRA/CRN) | 8 |
| Simplify the clinical trial process for enrolling participants in COG trials | “I also think that I can’t say enough simplifying especially for COG the process of not only being a member of COG but also simplifying the process that you know when you are navigating the COG website and you are typing ALL or you are typing AML and 6000 different studies come up and 6000 different pieces come up. But it’s not so easy to look and say okay I have a relapsed patient or refractory patient that has a Philadelphia-like mutation. If you look enough you can find what’s available but it’s not as easy to navigate. So I think people get frustrated.” (Female, 35-44 years, Physician involved in enrollment) | ||
| Leverage the existing NCORP infrastructure to improve the clinical trial process | “If COG could leverage that NCORP infrastructure instead of giving it to one institution we already discussed that. I think that would make it a lot easier, but operationally on their end that could become a nightmare. I understand that it had to complicate things, but it would also allow us to be able to enroll better, easier.” (Female, 45-54 years, CRA/CRN) | ||
| AYA coordinators and navigators | Build strong relationships between the AYA and coordinator/navigator, such as through the investment of time and resources | “But if there was someone who maybe was focused more on that population because I suspect that you need somebody who interacts with younger patients in a different way a little bit than older patients. And so somebody who maybe is younger and might appreciate the barriers and challenges that a younger population has rather than an older population.” (Female, 35-44 years, Physician involved in enrollment) | 5 |
| Strengthen communication between AYA coordinators and physicians or other providers | “I really think the major thing that’s been helpful is to have a dedicated person on each side that communicates. I think as just in a big institution with no defined people, it’s hard.” (Female, 55-64 years, Physician involved in enrollment) | ||
| Have AYA coordinators, navigators, or other AYA champions involved in every step of enrollment process as they are better able to communicate with AYA population | “I think having people that understand this population and are interested in working with them, meeting them where they are. I think that would make a huge difference in the success of these patients.” (Female, 45-54 years, CRA/CRN) | ||
| Advocates and mentors | Have AYA cancer survivors who have completed trials be lay navigators, mentors, and advocates for current patients | “A lot of times our patients have asked ‘How can I give back?’ … then we offer this program … typically, it is a lot of our younger individuals that are so happy to participate in it and really a rewarding experience for the next—to the next cohort to come through. (Male, 25-34 years, Patient Advocate) | 9 |
| Promote AYA self-advocacy and autonomy | “We offer the ability to build a complex care binder for any of our oncology patients. …So they can take it to any other provider if they’re out of state or out of network at the time and immediately present it to that team so that they can actively give the correct course of action.” (Male, 25-34 years, Patient Advocate) | ||
| Community advocates can also communicate information with the AYA population | “People wouldn’t even realize what would be available for them. Community advocates are always good as well—to be able to engage…” (Female, 35-44 years, CRA/CRN) | ||
| AYA working groups | Form AYA committees whose focus it is to improve AYA accrual onto clinical trials and bring awareness and discussion to the enrollment challenges faced by this group | “We started an AYA committee three years ago with the help of [name]. We looked at all of our data and at that point we were only getting about 3.0% of AYA on clinical trials. And so we made a concerted effort to improve our accrual and get it up to 6.7% at the end of our five-year grant period. So it’s certainly something that we are cognizant of and aware of. … Being the AYA experts you are, it’s a difficult group of patients." (Female, 65-74 years, NCORP Site PI) | 3 |
| Increasing awareness | Create AYA-specific advertisements | “Other than trying to talk about like what would the marketing needs be with it and have not gone a whole lot further. … When we’re advertising, it’s including them in that lump they’re in the same—they use our same branding, they’re in the same broadcasts—well, media area—but I don’t know how much of our work benefits them. … They do have stuff listed on their website with us, but specifically AYA, I don’t know.” (Female, 35-44 years, CRA/CRN) | 5 |
| Better evaluate the needs of the AYA population | “If you want to do an AYA marketing campaign, you could evaluate, ‘What do I have in my portfolio, what could I add to it to make it stronger to increase our enrollment with it, to be able to help push that information back to our physicians into even the public?’” (Female, 35-44 years, CRA/CRN) | ||
| Increase advertising efforts across sites and outside of oncology | “How do we even let people know that—of this age group - ‘You can come here’? We are about two hours away from a major city that has a children’s hospital and they definitely advertise it. … But while we do really well with advertising that pediatric hospital within our adult groups, that middle age bracket is like, ‘Where do we go? What do we do?’ “ (Female, 35-44 years, CRA/CRN) | ||
| Increase social media efforts for clinical trial advertising | “I think one of the challenges that we probably have, or one of the things that we could probably do to improve our AYA enrollments would be to put more effort into marketing our clinical trials program through social media. That’s been a big challenge for our healthcare system in terms of trying to embrace social media. We finally have acceptable use policies. Our healthcare system recognizes that people ger their news from Facebook. It sucks, but that’s where they—that’s where they go in the morning, and we’re gradually increasing our presence to hopefully—the end goal is to have every patient that comes in the door to our healthcare system—I don’t want to say expecting to go on a clinical trial, but really have them understand and expect that they’re going to be screened for a clinical trial and that’ll be part of the discussion with their doctor, whether it’s on the pediatric side or the adult side. I think we have a ways to go there.” (Male, 35-44 years, NCORP Site Administrator) | ||
| Delineation among doctors | Providers with a subspecialty may have better awareness of trials available for specific disease sites | “Currently if a physician’s a generalist, it’s hard to remember that there’s a study open for such and such disease when your institution has 300 studies open. So it really helps to have dedicated physicians that are dedicated to doing clinical research and that are dedicated to a specific disease type. I think that would affect AYA, as well as adult.” (Male, 65-74 years, NCORP Site PI) | 2 |
a
AYA = adolescent and young adult; ALL = acute lymphocytic leukemia; AML = acute myeloid leukemia; AV = audiovisual; COG = Children’s Oncology Group; CRA/CRN = clinical research associate/clinical research nurse; EMR = electronic medical record; NCORP = National Cancer Institute Community Oncology Research Program; PI = Principal Investigator; RRA = Regulatory Research Associate.