A video presentation with voice-over highlights specific examples of successful models of minority recruitment strategies. The Ford model is a framework for minority recruitment describing barriers and facilitators to minority recruitment based on their impact on potential participants’ awareness of cancer clinical trials, opportunities to participate, or acceptance or refusal of participation.
Recruiting a particular minority population using more traditional methods of minority recruitment (e.g. health system referral, mass media) may be an alternate approach to cultural tailoring. In this approach, investigators may simply focus more traditional recruitment methods on a particular racial or ethnic population to increase the number of minority enrollees. For example, social marketing (e.g. TV, radio, or newspaper announcements; brochures, newsletters, flyers) for clinical trial recruitment can be aimed at a particular minority group by focusing on specific minority communities or broader minority media markets. Investigators may also try to increase the yield of health system referrals by partnering with hospitals, clinics, or physicians serving minority populations. While the nature of this targeted clinical trial referral process may not differ significantly from that used with all patients, focusing efforts among minority-serving institutions and providers may simply increase access to potential minority participants. Another promising approach for minority recruitment is the use of local or institution-based cancer registries established specifically for the purpose of building a database of potential minority participants. Previous studies have demonstrated that all of these adapted methods are frequently used in combination to increase minority enrollment.
Given the potential cultural gaps between racial and ethnic minorities and the clinical research enterprise, minority recruitment in cancer clinical trials often relies on culturally “tailored” recruitment methods. In other words, researchers attempt to design or adapt recruitment methods that are in accord with the cultural framework of a particular minority population. Examples include recruiting for cancer clinical trials in community-based settings (e.g. churches, barbershops, beauty salons) or via existing community groups (e.g. civic groups, neighborhood associations). For instance, researchers have recently begun utilizing trained laypersons (“patient navigators”) to engage minority patients both in their communities and in certain health care settings to increase minority enrollment into clinical trials. The patient navigators often serve as a bridge between racial and ethnic minorities and the clinical research enterprise. Patient navigator interventions may allow researchers to improve the yield at all 3 junctures of patient engagement described in the Ford model. In efforts to increase awareness of clinical trials, patient navigators or other trained laypersons have engaged minorities in their own communities to increase awareness both about clinical trials and about the vital relationship between clinical research and advancements in health care. Patient navigators may also increase opportunities for trial participation by guiding minority patients through the frequently complex series of diagnostic or staging clinical visits that often precede the identification of suitable clinical trials. Finally, once a patient is offered enrollment in a trial, a patient navigator may facilitate potential participants’ informed decision-making at the point of entry into a trial by addressing their questions about the trial procedures or the informed consent process. While cultural tailoring often requires some adaptation to fit a particular cultural framework, researchers must acknowledge the heterogeneity within racial and ethnic minority groups to avoid sweeping generalizations about large groups that may or may not apply to a particular minority sample population. In order to avoid this pitfall, researchers should actively seek input on specific cultural norms, cultural barriers, and high-priority health care needs from members of the communities that are part of the actual sample population. Community members may have insight on the predominant cultural framework within a community that may inform the approach to recruitment as well as overall study design. These partnerships with community members are generally most fruitful when formed and cultivated in advance (sometimes for several years) of the need for trial recruitment.
Examples of Successful Recruitment Methods or Programs
|Study||Minority populations||Study Design||Recruitment Approach||Outcomes|
|Minority-Based Community Clinical Oncology Program(MBCCOP)
J Clin Oncol 23:5247-5254.
|American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and Hispanic or Latino||Pre-post assessment of minority accrual||Working groups in multiple cities comprised of hospitals, clinics, and clinical research staff partnering with cancer centers or oncology cooperative group research bases||Increased accrual of non-whites to clinical trials following start of program|
|Establishment of a Recruitment, Retention, and Outreach Core (RROC)J Clin Oncol 24:2209-2215||Primarily African American||Case reports of minority recruitment and associated costs following implementation of RROC||Centralized Cancer Center Core focused on providing consultation to PIs on minority recruitment and linking CCC to internal and external resources for minority recruiment||N/A|
|Recruitment budget supplements for specific research sites in multi-site studiesClin Trials. 2011 April ; 8(2): 214–223||American Indian orAlaska Native, Asian, Black or African American,
Native Hawaiian or Other Pacific Islander,
and Hispanic or Latino
|Case reports of minority recruitment at designated targeted recruitment sites||At inception of multi-site study, sites with track record of minority recruitment submit for budget supplements to maximize minority recruitment at that site to fund tailored recruitment approach for minorities||N/A|
Approaches can be targeted or tailored.
Targeted approaches are comprised of recruitment methods specifically aimed at a particular racial or ethnic population to reach members of that subgroup with greater frequency.
Tailored approaches are comprised of recruitment methods designed in accordance with the cultural framework of a particular minority population.
These approaches may be used alone or in combination.
Examples of Targeted Approaches include social marketing, such as TV, Radio, and Newspaper Ads consumed more frequently by a racial or ethnic subgroup of interest.
Examples of Tailored Approaches include the use of patient navigators to bridge potential cultural gaps between potential minority participants and research institutions. Another example may include the adaptation of standard recruitment materials or approaches to fit the cultural norms of a particular subgroup.
Here are some minority recruitment strategies currently in use…
Community Clinical Oncology Program, or CCOP
Clinical Trials Shared Resource, CTSR
Increasing Minority Participation in Clinical Trials, or IMPACT
Facility for Access to Enrollment Services, FACES
and the Midwest Cancer Alliance, or MCA
Let’s look first at the Community Clinical Oncology Program, or CCOP, sponsored by the National Cancer Institute, Division of Cancer Prevention
The CCOP includes a subset of Minority-Based Community Clinical Oncology Program (MBCCOP) awards, which are cooperative agreements designed to build clinical trials outreach and management capacity in community healthcare facilities providing cancer care to minority patient populations.
The Minority-Based Community Clinical Oncology Program (MBCCOP) awards connect community physicians serving minority populations to research institutions in order to increase accrual of minority participants into clinical trials.
A Minority-Based-CCOP must have 40% of their new cancer patients from minority populations.
Investigators and community health care providers may access
Links to resource databases, population databases, and registries;
Access to a large and broad menu of NCI-sponsored Phase I, II, and III clinical trials within the CCOP network for potential collaborations;
Access to the Biometry Research Group for statistical analysis;
and references and a publication database for cancer prevention science in the clinic and laboratory;
For more information visit the CCOP program online.
Now let’s look at another Minority Recruitment Strategy Currently in Use – Patient Navigation.
Patient Navigation was founded and pioneered by Harold P. Freeman at Harlem Hospital in New York City in 1990 for the purpose of eliminating barriers to timely cancer screening, diagnosis, treatment, and supportive clinical care.
Concepts for Clinical Care include recruitment practices for clinical trials to increase minority participation.
Patient navigation: Initiatives across time
In the last 10 years the exploration of patient navigation has been funded by federal agencies such as the National Cancer Institute, Health Resources and Services Administration, and the Centers for Medicare and Medicaid Services. In addition, nonprofit foundations such as the American Cancer Society have supported the development of dozens of patient navigation programs at hospitals nationwide.
Let’s review barriers to care typically addressed by patient navigation.
Heath System Issues include location of health-care facility, system problems with scheduling care, and medical and mental health comorbidities.
Communication Issues include Language discordance, communication barriers with medical personnel, and literacy.
Financial Issues include insurance, transportation, employment.
Other Considerations include child or adult care issues, attitudes towards providers, out of town or country, and patient disabilities.
Psychosocial Issues include perceptions or beliefs about tests or treatments, fear, and emotional or practical support.
When applied to minority recruitment…
Patient navigators provide support services to overcome common barriers for minority patients who are considering enrollment in clinical trials. Common barriers include psychosocial issues such as fears of experimentation and discomfort with randomization and blinding. Navigators also may address health system issues such as coordinating study visits. Finally, patient navigation may be valuable in addressing communication issues including answering patients’ questions during the recruitment and enrollment process and sharing patients’ needs with research staff.
Examples of patient navigation services to address these issues include brief clinic-based education about clinical trials; finding community resources to meet needs (local housing, transportation, etc.); solving problems that interfere with adhering to recommended treatment; and assistance in communicating with insurance agencies.
Next we will discuss two models for Patient Navigation for minority recruitment
Clinical Trials Shared Resource CTSR and Increasing Minority Participation in Clinical Trials IMPACT
Let’s look at the Clinical Trials Shared Resource, or CTSR, in use at Nashville General Hospital at Meharry and Vanderbilt Ingram Cancer Center, both in Nashville, TN
Meharry Medical College is a minority-serving educational institution with Nashville General serving as its clinical facility. Nashville General provides outpatient and inpatient care predominantly for patients who are under-insured or uninsured; 55% of the patients are African American. The CTSR was established at Nashville General and in collaboration with the Vanderbilt-Ingram Cancer Center.
The CTSR Model…
Uses databases to match trials to patients’ needs, identify patients’ needs while employing nurse and research staff navigators.
Investigators developed a model for successful recruitment of minorities into clinical trials based on patients’ needs. An infrastructure was created to facilitate communication between Nashville General and Vanderbilt toward the goal of identifying Nashville General patients who may be eligible for clinical trials.
You can learn more about the CTSR model online.
Another strategy is IMPACT, which stands for Increasing Minority Participation in Clinical Trials.
IMPACT is in use by Morehouse School of Medicine-Tuskegee University and the University of Alabama at Birmingham Comprehensive Cancer Center Partnership.
Investigators are Dr. Upender Manne, Dr. Ed Partridge, Dr. Mona Fouad
Patient Navigators and Community Health Advisor Networks aim to provide equal access to clinical trials for low-resource and minority patients. Navigators also overcome barriers to participation and help patients navigate through the healthcare system. Finally, patient navigators assist with both the recruitment and retention of African American cancer patients in therapeutic cancer clinical trials.
Learn more about IMPACT on the UAB website.
Another Minority Recruitment Strategy Currently in Use is the Recruitment and Retention Shared Facility or RRSF.
It is based at the University of Alabama at Birmingham (UAB) in the Division of Preventive Medicine. The RRSF is led by Dr. Mona Fouad and was founded in 1998.
Based on years of successful minority trial recruitment, the RRSF staff collaborates with UAB researchers to enroll minority trial participants
The RRSF utilizes innovative recruitment techniques and culturally relevant materials to engage participants from minority.
Services Provided by RRSF include…
Help with developing minority specific recruiting/retention plans; maintaining a real-time tracking by racial and ethnic subgroups; identifying potential population-specific participants and reaching them; and conducting community outreach activities, onsite clinical trial recruitment, workshops on recruitment, and focus groups.
For more information please visit https://www.uab.edu/medicine/dopm/affiliated-centers/shared-facilities/rrsf.
The last Minority Recruitment Strategy we’ll explore is the Midwest Cancer Alliance, or MCA
MCA’s medical director is Dr. Gary C. Doolittle.
The Midwest Cancer Alliance (MCA) is a network compromised of the University of Kansas Cancer Center and 14 institutional partners, including universities, health system clinics, and hospitals throughout Kansas and western Missouri.
The MCA utilizes telemedicine to reach out to the community and provide care close to home for rural residents in the region.
Through the Alliance, patients can enroll in cooperative group and pharmaceutical trials at their local hospitals. This minimizes the burden of travel to access these trials, which are traditionally available only in urban cancer centers.
Learn more about the strategy at the Midwest Cancer Alliance website.
Find more information about Patient Navigation and Clinical Trials in these related articles.
- Schapira, L. and R. Schutt, Training Community Health Workers About Cancer Clinical Trials. Journal of Immigrant and Minority Health, 2010: p. 1-8.
- Steinberg, M.L., et al., Lay patient navigator program implementation for equal access to cancer care and clinical trials. Cancer, 2006. 107(11): p. 2669-2677.
- Ford, M.E., et al., Enhancing Adherence Among Older African American Men Enrolled in a Longitudinal Cancer Screening Trial. The Gerontologist, 2006. 46(4): p. 545-550.
- Robinson, J.M. and W.M. Trochim, An examination of community members’, researchers’ and health professionals’ perceptions of barriers to minority participation in medical research: an application of concept mapping. Ethn Health, 2007. 12(5): p. 521- 39.
- Wujcik D and Wolff S. J Health Care Poor Underserved. 2010 February ; 21(1 Suppl): 38–50I.
This presentation has been brought to you by EMPACT, enhancing minorities participation in clinical trials. http://www.empactconsortium.com