In a 17 minute presentation, Dr. Fouad describes engaging rural residents in clinical research studies.
Though successful models of minority recruitment have been utilized in cancer clinical trials, it is often difficult to gauge how well any recruitment approach will perform in a particular subgroup. For example, community-based efforts designed to increase the access of African American cancer patients to a cancer center may be less effective among Latinos. In another instance, providing transportation for a primarily urban, underserved population may be less feasible for a more widely dispersed underserved population residing in rural areas. Moreover, there is a tremendous amount of heterogeneity even within racial/ethnic subgroups. For example, the Mexican Americans residing in the southwest U.S. and Cubans living in South Florida may both report Hispanic ethnicity, but may have multiple cultural differences based on differences in their respective lineages. However, these and other differences among underserved subpopulations do not negate the possibility of adapting minority recruitment strategies from across different groups. Instead, investigators and research staff should be prepared to identify variation in barriers, facilitators and cultural contexts influencing minority enrollment decisions in cancer clinical trials. We will use the Ford conceptual framework to demonstrate guiding principles that can be used to gauge the adaptability of an intervention for multiple subpopulations.
Assess differences/similarities in barriers/promoters to minority recruitment
To determine the adaptability of a particular minority recruitment effort across multiple populations, investigators must first determine the barriers and facilitators at work in each population. In some instances, common barriers and facilitators may influence enrollment across multiple populations. In these cases, there may be some potential to use a recruitment approach that mitigates or optimizes the barriers and facilitators, respectively. For example, if local populations of African Americans and Asian Americans both have strong beliefs in the influence of fate on health outcomes, members of both groups may not be inclined to seek care in clinical trials when faced with terminal diagnoses. Instead, based on a belief that their health outcomes are pre-determined, members of each group may be less inclined to seek aggressive treatment such as that often offered in clinical trials. In response to a resultant reluctance to enroll, a common recruitment intervention, based on educating local African Americans and Asian Americans about the role of clinical research in health care while acknowledging their health beliefs, might be effective in increasing their enrollment in clinical trials. Though this is an example focused on a single barrier, frequently multiple barriers and promoters collectively create some net willingness (or unwillingness) to participate in a trial. In these instances, investigators and research staff must identify multiple barriers and promoters, as well as the relative importance of each within each subgroup. Though adaptable interventions may require some minor tweaking to fit the cultural framework of each subgroup, the general premise of a recruitment approach may be applicable in multiple contexts. Any minor adjustments made to a common minority recruitment approach should be informed by input from members of each subgroup to ensure appropriate accordance with their respective cultural frameworks.
Assess point of engagement along recruitment pathway
The Ford model lists 3 basic points of engagement in the context of minority recruitment: 1) Patients’ awareness of a trial 2) Patients’ being offered the opportunity to participate in a trial 3) Patients’ acceptance or refusal of trial participation. In order for a minority recruitment strategy to be effective across multiple subgroups, investigators must identify some shared challenges at similar points of engagement. For example, recruitment efforts aimed at increasing minority awareness in one subgroup largely unexposed to clinical trials, may be less effective in another subgroup that is aware of clinical trials but rarely invited to participate. Conversely, if two groups are disinclined to accept an offer to participate, a common approach to increase their acceptance rates may be effective in both subgroups. For example, in a sample population comprised of Latino and Asian immigrants, strong kinship ties, particularly among the elderly, may influence patients’ decisions to participate. In such an instance, an intervention designed to educate not only the participant but also family members about the trial being offered may be effective. Furthermore, the inclusion of a family member in the informed consent process may also be an effective means of increasing participation in subgroups with strong familial influences. Again, the specific aspects of any intervention designed for a particular subgroup should ideally be informed by input from that subgroup to assess some measure of acceptability.
We are here today speaking with Dr. Mona Fouad, Professor of Medicine at the University of Alabama at Birmingham. Dr. Fouad serves as the director of both the division of preventive medicine and the UAB minority health and health disparities research center. She also serves as the co-leader of the Cancer Control and Population Sciences Program at the UAB Cancer Center.
Welcome, Dr. Fouad we’re happy to have this opportunity to talk with you, and thank you for taking the time to do so. Over the course of your career you’ve been successful in engaging rural populations in research studies. In particular, you’ve worked with African Americans living in largely impoverished rural communities.
We would like for you to share insights related to some of the facilitators and challenges associated with working with this often underrepresented population. Let me start by asking you how you first became involved with minority recruitment efforts?
When I first started my work as a fellow at UAB I found out that there are challenges with enrolling minorities in clinical trials. And as a faculty at the division of Preventive Medicine then, I found that we have several studies. But they were very small numbers of African Americas enrolled in the trials.
By talking with other investigators, I found that they had a lot of challenges and they almost gave up and they did not try to make any effort to reach out to minorities to include clinical trials because of all the barriers and all the challenges. This is why I thought maybe I can focus and find ways to overcome these challenges to enroll minorities in clinical trials and that is where we established our recruitment retention unit here at the division of preventive medicine to try in a coordinated fashion reach out to the community and build the trusting relationships.
To be able to understand how can we engage in interception.
You talk a little bit about engaging African-American communities. It also seems that you have had a specific interest in rural minority populations as well. And this is unique because most academic centers like UAB are located in large cities. Therefore many of the people participating in the research studies hail for the immediate metropolitan areas.
What motivated you to study more rural minority populations?
My interest was to give the opportunity to every person to have a chance to be a part in our research study. Rural populations have compounding challenges not only that they don’t have the trusting relationship with large academic institutions, but they have other barriers being in remote areas, not having transportation, not having access to physicians, not having access to the knowledge and the media that urban cities usually have, which made me think that since all our populations, groups, especially African American, need to have a chance in being part of this study.
It would be good to reach out and find out how can we engage also rural African-Americans. One more thing, Alabama, in general, most of the African Americans live in rural areas and counties. We have the Black Belt counties in Alabama. which is about fourteen to seventeen counties. Almost seventy percent of the population are African Americans.
So you mention some unique challenges that are related to large distances from the places where these people reside, and the academic medical centers. Are there specific ways that you all are able to engage these populations despite these distances?
The distance is one factor. By providing transportation you can overcome this barrier, but there are more than that – the distance actually also represents a disconnect, not only the transportation. Rural communities usually live within their networks and they only reach out to big academic institutions and medical centers when they are maybe of a crisis like end of life situations, they usually get their usual medical cares in health departments or community health centers. But they only come to large medical centers when they have a serious disease. So there is a disconnect to get them engaged, you had to go out there, talk to community leaders, do some orientations and town hall meetings with the community members, to give them more information what exactly happens at medical centers, not only that there are the experts for serious diseases.
So the National Institutes of Health first issued mandates for investigators to increase minority enrollment in clinical trials almost 20 years ago. But no such mandates have been issued for rural populations. Based on your experience what progress has been made in understanding addressing the barriers to recruitment of rural populations to cancer clinical trials.
NIH in general, their mandate was to recommend that we engage all minorities in clinical trials. They did not specify rural, but as you know there are large numbers, a large percentage of the minorities live in rural populations. They are also mandated or recommended engagement of underserved populations.
We know that most of people that live in rural communities are mostly low income communities. There are not that many resources especially in our in the south east region. Most of our rural communities are the most poorest counties in the United States. So while the NIH mandate was not specific it was logical that we need to reach out to the rural communities.
You have also been successful in recruiting more urban African-American populations in cancer clinical trials. Are there specific recruitment strategies that you have used successfully in urban minority populations that you have been able to adapt for rural African American populations?
So, there is one thing that I can think of that can be adapted to any communities, if it’s urban or rural, especially with minority populations, is building trust. So building trust to reach out African American communities in urban or reaching out African Americans living in rural communities would be the same.
You can’t just go into the community and talk to them. You have to know who is the gatekeepers. You have to build the relationships, you have to build partnerships. Partnerships are very important for us to engage the community. And we can’t forget for Alabama, one of our major rural counties is Tuskegee. It’s Makon country where Tuskegee lies in Makon county.
So for us to be able to go to the rural communities we had to build the trust, because Tuskegee also is embedded in our rural communities in Alabama. And that’s why we have to start there before we go anywhere else.
So in your focus on African American rural populations, I’m sure you’re observed that some underrepresented populations share some historical, cultural, and behavioral similarities.
How is the racial make-up of this population interacted with their place of residence to influence your recruitment efforts?
So with rural populations, when they live in a small town. Everybody knows the other person. And they have very strong social networks, so you can’t talk to a person with without talking to the other. You can’t talk to a mother without engaging the daughter. You can’t talk to a daughter without engaging the sister and the mother.
You can’t talk to church members without engaging the pastor, so they have their own cultural norms and also they can be empowered because if you can reach the right people, they can tell each other. There is a lot of personal contacts and personal testimonials, and that’s why when we reach out to the minorities in rural counties.
The way we did that, first we contacted leaders in the community, like a pastor or community organizations, once we made the contact with the leader, they are the ones that invited the community to come minute to listen to us. You can’t go to a rural community and invite them. One of them has to make the invitations, and we would be their guests.
Once we get there and we became the guest of that leader we got some credibility, we have some credibility there, and then we were able to open the dialogue and the conversation without any threatening without any demands without any expectations and listen to and answered questions. Once you do that the populations and residents became more comfortable and trusting and understanding that they can have a voice and they can ask questions and they can be informed and then they can make an informed decision about if they want to participate in a study or not. So we did that in one community to the other the community, to the next community. And that’s why we were able, for example, in our prostate, lung an ovarian cancer screening trial to recruit about a thousand African Americans from rural communities within ten months.
So, you referenced it a little bit earlier, but we’d like to hear more about the recruitment and retention shared facility and its role in the recruitment of rural populations for cancer clinical trials. We established through the UAB comprehensive cancer center, a shared resource to help investigators to recruit and retain participants in clinical trials. Not only any participants, but with a focus on African Americans because they are the largest minority groups in our state. And also to retain, to help retain these participants once they are enrolled in a study.
The reasons we did that is to have more coordinated approach to reach out to the communities. As I mentioned earlier, trust is a major issue in developing the relationships and have successful engagement of the communities. We have noticed that several investigators they go out and reach on their own the community.
So the community sees the medical center as fragmented. Everyone is going with their own message and everyone is trying to recruit a certain group of people and the community would look at UAB, as if it’s so fragmented they don’t know what they’re doing because they see UAB as one entity. So this coordinated facility, the aim of it is to coordinate these activities.
Now the same thing that we wanted also to help the investigators, because not all of them have the time or have the training to how to reach communities. The facility has staff and this staff is culturally trained of how to reach the communities, they are the same faces that reach out and go and talk to leaders and organizations, so they’re seeing the same faces and they’re seeing the same information coming to them from UAB instead of each investigator go on their own.
The other thing we wanted to build a trusting relationship with the community and the facility became that center where the community can come in and ask questions. We also know that investigators usually reach the communities when they have funding. So we go to our community when we have the grants and the funds and once the funds end, we’re out of the community.
What the facility did is to have a continuous relationship, even between grants. So we’re not in and out of the community, but we have the relationships there, and when an investigator has a grant, it needs recruitment of minorities in clinical trials. We can and we already have this relationship going.
What aspects of minority recruitment still need to be addressed to build on past progress and recruitment of rural populations into cancer clinical trials?
I think there are many aspects that still we don’t have, as investigators or as funding agency. One aspect are resources. Most funding sources see when you have a grant or a clinical trial, if it’s therapeutic funded by pharmaceutical company or federal funded by NIH, they don’t provide the investigators with enough resources to reach out in the communities.
Most of the residents in rural areas they have other life priorities and needs, that they need before they participate in the study. We mention transportation, so it’s going to cost them money to do that. They will have to leave a job because it’s going to take them a whole day to come to a medical centers and go back.
They have to take care of a child. Or they have to take care of an elderly family member. Rural communities don’t have the support that an urban city has. And we need to understand all these issues. Driving to a big city can to be a big thing, so we have to have the resources and the time to able to build the relationships and also provide the resources for our participants to be able to participate and come back and be retained, so these are issues like when we submit applications or we get funding from a funding source, they don’t have these things in place.
We have also to understand that access to care is limited. So if there are any follow ups or any side effects or any issues just that you have to take care of medically they have to come all the way back again to the medical center. So there are many things. Another thing is insurance. Some insurance companies don’t pay for therapeutic trials, and most of our rural community residents don’t have insurance.
Well, thank you for taking the time to share your experiences with us. In closing, I’d like to just ask, is there anything else about the recruitment of rural populations to cancer clinical trials that you would like to tell us before we conclude this interview?
I just want to say that with rural populations there are a lot of similarities between African Americans and Caucasian. Because Caucasians to white residents that live in rural communities have a lot of barriers similar to the rural African Americans.They are all disconnected from the big cities they have barriers of transportation. There is not that many education awareness going out in rural communities, so their recruitment can be a challenge similar to minorities, also. So we need to also be aware of this challenge.
Again, thank you very much for taking the and to help us understand some of the challenges and methods for recruitment of rural minority populations.
Thank you, I really appreciate your questions.