Efforts to Recruit the Economical ly Disadvantaged to National Clinical Trials

Mary S. McCabe, Claudette G. Varricchio, and Rose Mary Padberg

p ARTICIPATION in clinical trials offers pa- tients access to state-of-the-art therapy in a

research context, Initially available through cancer centers and select academic institutions, these tri- als are now more broadly available through the Community Clinical Oncology Programs (CCOPs). Because clinical trials were restrictive in many ways (eg, geography, type of institution, trial de- sign, limited awareness of the importance of broad representation), access for the socioeconomically disadvantaged (SED) was limited. After a brief review of the history of clinical trials, the efforts of the National Cancer Institute (NCI) to identify bar- tiers to patient participation in clinical trials is de- scribed, and recruitment efforts targeted toward minority and impoverished patients are discussed.

HISTORY OF CLINICAL TRIALS

A clinical trial is the systematic investigation of the effects of medications or methods, according to a formal study plan, in a human population. The purpose may be to evaluate treatment methods or to study the effectiveness of cancer detection and prevention methods. 1

Comparisons of medical treatments have long been made, either formally or informally, to de- termine the potential value of a therapy in a spe- cific patient population. As early as 1747, Lind evaluated sailors with symptoms of scurvy by comparing their responses to various diets and ob- served that those who ate oranges and lemons as natural sources of vitamin C had the most improve- ment. 2 Throughout the 1800s, similar types of comparative studies were conducted evaluating drugs or vaccines as treatments for smallpox, diph- theria, and cholera. 3 In 1887, the establishment of the National Institutes of Health gave formal ac- knowledgement of the contribution of medical re- search to advances in public health. 4 This formal funding of research in the areas of disease preven- tion, detection, and treatment promoted the devel- opment of clinical research methodology, which included the ability to tabulate data and apply an- alytic statistical techniques, s

Clinical trials continued to evolve in the early 1900s with studies primarily focused on the treat- ment and prevention of infectious diseases. In 1948, clinical trials entered a new era of scientific sophistication with the reporting of the first pro- spective randomized placebo-controlled trial con- ducted by the British Medical Research Council. The purpose of the study was to evaluate the effect of streptomycin as a treatment for tuberculosis. It appears to be the first formal effort to randomly assign patients to specific groups. 6 This particular study set the stage for clinical trials to be designed and undertaken as rigorous scientific evaluations that minimize investigator bias and the potential for subjective evaluation of resulting data. Through continued efforts to provide scientific structure and funding for such endeavors, anecdotal observation was replaced by empirical discipline based on in- ductive principles. Such trials address a specific, focused question or set of questions, use a formal method for obtaining a valid answer, include in- vestigators with both clinical expertise and re- search methodology, and are conducted in such a manner that accurate and timely conclusions can be drawn about the data. 7,s The prospectively de- signed controlled clinical trial has emerged as the foremost mechanism for clinical cancer research and is responsible, to a large extent, for the con- temporary advances in cancer care.

From the Community Oncology and Rehabilitation Branch, Division of Cancer Prevention and Control, and Cancer Ther- apy Evaluation Program, Division of Cancer Treatment, Na- tional Cancer Institute, Bethesda, MD.

Mary S. McCabe, RN, BA, BS: Clinical Trials Specialist, Division of Cancer Treatment, National Cancer Institute; Clau- dette G. Varricchio, DSN, RN, OCN, FAAN: Nurse Consul- tant~Program Director, Community Oncology and Rehabilita- tion Branch, Division of Cancer Prevention and Control; Rose Mary Padberg, RN, MA, OCN: Nurse Specialist (Clinical Tri- als), Community Oncology and Rehabilitation Branch, Divi- sion of Cancer Prevention and Control.

Address reprint requests to Mary S. McCabe, RN, BS, Clin- ical Trials Specialist, Division of Cancer Treatment, National Cancer Institute, Bethesda, MD 20892.

Copyright �9 1994 by W.B. Saunders Company 0749-2081/94/1002-000755.00/0

Seminars in Onco/ogy Nursing, Vol 10, No 2 (May), 1994: pp 123-129 123

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CANCER CLINICAL TRIALS TODAY

In 1955, the controlled clinical trial became a major resource for cancer research when the US Congress passed legislation and appropriated funds ($5 million) for an NCI program of cooperative clinical study directed towards better methods for the treatment of malignant disease. Currently, there are 13 clinical cooperative groups supported by the NCI, 12 of which are in the United States (Table 1). As of 1992, the cooperative group pro- gram included approximately 5,000 investigators at 1,300 institutions (hospitals and practices). There were 478 active treatment studies with 22,709 subjects entered on these protocols. 9

Because only about 3% of cancer patients enter clinical trials, a major goal of the NCI has been to ensure that trials are available in the community where the majority of patients are actually treated. To accomplish this goal, two separate outreach programs have been established. The Cooperative Group Outreach Program provides cancer patients with access to the same technological advances and quality of care that are available at major can- cer centers. The CCOP is a mechanism to bring clinical research and cancer control advances to the community. These programs have been successful in contributing patients to clinical trials and in- creasing the number of physicians and other health professionals engaged in clinical research.

Despite the success of general accrual efforts by these programs, they did not increase the number of minority and economically disadvantaged pa- tients participating in clinical trials. In 1989, the NCI established the Minority-Based CCOPs (MB- CCOP), a specific initiative to meet the needs of

Table 1. NCI-FundKI Clinical Cooperative Ontology Groups

Brain Tumor Cooperative Group (BTCG) Cancer and Leukemia Group B (CALGB) Children's Cancer Study Group (CCSG) Eastern Cooperative Oncology Group (ECOG) European Organization for Research and Treatment of

Cancer (EORTC) Gynecologic Oncology Group (GOG) Intergroup Rhabdomyosarcoma (IRS) National Surgical Adjuvant Breast and Bowel Project

(NSABP) North Central Cancer Treatment Group (NCCTG) Pediatric Oncology Group (POG) Radiation Therapy Oncology (RTOG) Southwest Oncology Group (SWOG) National Wilms' Tumor Study Group (NWTSG)

McCABE, VARRICCHIO, AND PADBERG

minority cancer patients and individuals at risk for cancer. The purpose of the MB-CCOP is to pro- vide access to a network of oncology programs that give the opportunity to participate in clinical trials.

On a federal level, the US Department of Health and Human Services requires that Public Health Service grants and cooperative agreements involv- ing human subjects accomplish the following:

�9 . . include minorities and both genders in study popula- tions so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them . . . . If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationaIe for exclusion or inadequate representation should be provided. The composition of the proposed study pop- ulation must be described in terms of gender and racial/ ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be ad- dressed in developing a research design and sample size appropriate for the scientific objectives of the study. 1~

The appropriate inclusion of these groups of pa- tients is a priority for many very important rea- sons. The generalizability of clinical trial results depends on how restricted the study sample has been and the nature of the restrictions.lt Because clinical trials offer access to state-of-the-art ther- apy, they should be available to eligible patients who wish to participate, regardless of race or eco- nomic status. Clinical trials that include the eco- nomically disadvantaged can focus on specific fac- tors that may affect in a unique way on the prognosis and survival of this group.

CANCER AND THE POOR

In 1973, a study by Henschke and colleagues ~2 established, from a national perspective, that can- cer incidence and mortality had increased alarm- ingly in the black community, and both were higher than in white Americans. Since that study, collection of cancer data by race has become more extensive. However, race may be only one con- tributor to higher cancer mortality. A complex in- terrelationship exists between race, poverty, and cancer. Too often the component of poverty is overlooked. Race, in relation to cancer, is one in- dicator of culture and lifestyle. Poverty is a marker for many negative events in life that affect

ECONOMICALLY DISADVANTAGED AND CLINICAL TRIALS 125

health. 13 Neither factor, race, nor poverty func- tions in isolation. Freeman 13 proposes that "pov- erty acts through the prism of race." This means that in terms of cancer, race is a surrogate for a specific culture and behavior that is diminished by poverty. The Committee on Cancer in the Eco- nomically Disadvantaged of the American Cancer Society (ACS) has stated that low socioeconomic status (SES), regardless of race, is a major deter- minant of cancer survival, la

In 1989, the ACS published findings of regional hearings on cancer and the poor. 15 They reported the following results: (1) poor people lack access to quality health care and are more likely than oth- ers to die of cancer; (2) poor people face substan- tial obstacles in obtaining and using health insur- ance and often do not seek needed care if they cannot pay for it; (3) cancer education and out- reach efforts are insensitive and irrelevant to many poor people; (4) fatalism about cancer prevails among the poor and prevents them from gaining quality health care.

There is substantial evidence that the poor are more likely to be diagnosed with cancer when the disease is advanced and when the treatment op- tions are significantly more limited. 16 The experi- ence of the MB-CCOP program is that there is a lack of clinical trial protocols that target the ad- vanced stages of disease with which the economic and ethnic minorities present at the time of diag- nosis. 17

Recruitment efforts and entry of the economi- cally disadvantaged to clinical trials may face ob- stacles because of patient finances, perceptions of health, and specific attitudes toward clinical trials. An important historical example is the concern of black Americans about clinical trial participation as a result of the experience with the Tuskegee syphilis study. Although the project originally in- tended to meet real health needs, it ultimately be- came an unethical study exemplified by the ex- traordinary measures taken to ensure that the patients in the experimental group did not receive effective treatment. 18 This study of untreated syph- ilis in the black man is the longest nontherapeutic experiment on humans in medical history. 19 Sixty years later, it is the reason an atmosphere of dis- trust and suspicion hampers cancer research efforts in many black American communities.

When considering recruitment of the economi- cally disadvantaged to clinical trials, information

and understanding of the ethnic and cultural envi- ronment as well as the barriers faced by the target group are required. There are many similarities among the economically disadvantaged and among the different ethnic groups, but there are also many differences that are specific to the poor of a given cultural group. Any strategies to recruit specific groups to clinical trials must take these character- istics into consideration.

Recognition of the need for inclusion of low SES patients and their actual inclusion in clinical trials is a great challenge that requires specific funds and sensitivity to this patient population.

GENERAL ISSUES OF RECRUITMENT

Access to Care

Four major factors generally affect access to care and therefore recruitment to clinical trials. These factors are availability, affordability, acces- sibility, and acceptability. 2~ These four factors may be more critical to successful recruitment ef- forts in prevention trials than in treatment trials.

Access and costs may be the main barriers to participation in any trial. Income and insurance are critical factors in affording health services. 2~ Transportation to the clinical site is not covered by public or private insurance, nor is the cost of tem- porary housing for patients and family members who must travel long distances for care. These costs can be particularly substantial for cancer pa- tients undergoing daily therapy. In addition, there are hidden costs that are those related to lost time at work by the patient or accompanying family member and child care. The burden of daily sur- vival weighs heavily on the poor, and health con- cerns are often ignored until pain is significant.15

Barriers to Participation

Other service delivery elements that contribute to lack of participation in clinical treatment trials are long waiting time; inconvenient hours of ser- vice, a confusing atmosphere, and not seeing the same doctor twice. These barriers are compounded by fear of doctors and hospitals, fear of diagnosis and prognosis, and a lack of faith in the medical profession. 2~ Affordability is a formidable barrier to medical care and therefore to participation in clinical trials by poor, minority, and elderly pa- tients. Cost of participation in prevention trials may be a particularly strong barrier if the perceived

126 McCABE, VARRICCHIO, AND PAl)BERG

benefit of participation is vague and remote and the risk from nonparticipation is not perceived as strong.

Some of the patient-perceived barriers to partic- ipation in clinical trials by the economically dis- advantaged are presented in Table 2. There may also be physician factors that are perceived as bar- tiers. In surveys of the Eastern Cooperative On- cology Group and the NCI-funded CCOPs, the major reason for not entering eligible patients on protocol was a decision made by the physician. 21 The most frequently listed concerns included ad- vanced age and fragility of the patient, practical problems of inadequate health care coverage, and geographical location of the patient's residence. Other specific protocol-related barriers identified were overly complex procedures, excessive testing requirements, excessive costs, and an excess per- sonal burden placed on the patient.

Patient recruitment efforts often ignore the real- ity of access and affordability and are thus largely irrelevant. This problem is compounded by the lack of informational materials that appeal to dif- ferent cultures or educational/reading levels. 22

Facilitators to Participation

Participation in clinical trials for the economi- cally disadvantaged is facilitated by the following factors: adequate information and education about the risks, benefits, costs, and time commitment required; peer group norms that are supportive of the goals of the trial; endorsement of the goals of clinical trials by church, the cultural or social group, and the employer; improved access to the health care system and the specific location where the trial is being conducted; a perceived benefit to the individual from participation; and minimal ac- tual cost to the individual in terms of time lost from work, transportation, and child care.

Foley and Moertel 2~ in a report of a survey of

Table 2. Barriers to Participation in Clinical Trials

�9 Fear and distrust

�9 Perception of cost, direct and indirect, to the patient �9 Diff icult access to the clinical site �9 Recruitment information and consent are not in the

language used by the patient

�9 Lack of valid and cultural ly appropriate sampling tools or

questionnaires �9 Lack of protocols available for the disease and stage at

presentation.

the members of the North Central Cancer Treat- ment Group identified strategies to improve patient participation in clinical trials. These were relieving patients or third-party payers of protocol-related financial burdens of expensive drugs or tests con- ducted purely for research purposes, improvement of the public image of clinical trials in general, modification of protocols to make them more ex- peditious and less cumbersome, and specific pro- tocol educational materials for patients and fami- lies.

Recently, the NCI conducted in-depth telephone interviews with key staff members at 26 clinical sites that have access to minority and/or low- socioeconomic populations. (This group also in- cluded low literacy populations.) The interviews were conducted to identify key issues regarding the recruitment and retention of specific minority groups. The major areas identified by respondents include increased education/information regarding cultural characteristics of specific populations, as- sistance with economic and logistical barriers that frequently hamper special population recruitment, and identification of appropriate points of access into the target communities. However, it should be noted that this information is from the perspective of the health care team. Future interviews are planned with representatives of the targeted popu- lations to discuss perceived cultural and economic barriers for recruitment to clinical trials.

GENERAL RECRUITMENT STRATEGIES

In discussing issues relevant to recruitment, it is apparent that there is not an ideal formula that produces success in every situation. Table 3 pre- sents some general recruitment suggestions. Each geographic area, institution, and target group has unique sets of assets and liabilities. It is essential to identify the special population to be targeted. The cultural needs and existing barriers in this group must be identified. 23 A strategic plan is then de- veloped to provide a framework for staff decisions about the use of resources to be directed toward recruitment efforts. 24-26 After identifying priorities and a plan of action, division of labor and respon- sibility can be established. All involved staff should be aware of this plan and receive specific information and education. Group discussion and role-playing may assist in understanding some of the target group's barriers. Awareness of cultural

ECONOMICALLY DISADVANTAGED AND CLINICAL TRIALS 127

Table 3. Suggestions for Increasing Recruitment to Clinical Trials

�9 Identify barriers for the targeted population. �9 Determine key decision makers in these targeted groups. �9 Advertise the trial where both physicians and potential

subjects will see it.

�9 Offer tours of the clinic for prospective subjects. �9 Make recruitment/retention a top priority for your

research staff. �9 Create "user-friendly" methods for subjects/staff to

comply to protocol requirements. �9 Provide feedback to referral sources about the status of

the trial. �9 Speak informally to colleagues to promote protocol

awareness and interest. �9 Speak at professional and community meetings about the

protocol. Request referrals. �9 Publicize eligibility requirements on brochures and flyers. �9 Provide culture and language-appropriate informational

materials. �9 Contact potential subjects through fairs, community

events, churches, and other resources. �9 Identify and adapt successful methods used in similar

recruitment efforts for your targeted population.

Data from Spilker. 23

norms and taboos should be reflected in all recruit- ment efforts. Evaluation and modification of the recruitment plan should be performed on a regular basis. These efforts can be time-consuming, and quantifiable results may be elusive at best. Con- sistent, sustained efforts to improve minority re- cruitment will ultimately yield knowledge about successful strategies.

Specific Strategies for the Recruitment of the Economically Disadvantaged

This discussion is a compilation of suggestions from readings, interviews, and symposia about re- cruitment of minority subjects. Interested investi- gators need to be aware that it takes time to de- velop an information/knowledge base from which to start a high-priority recruitment program for a special population.

The SED often do not receive information about availability of clinical trials. The typical sources of information such as a physician's office, newspa- pers, or magazines may not be available or used by the target subjects. A recruitment strategy is to schedule public presentations of relevant informa- tion at sites that are convenient for these popula- tions. A means of attracting the largest number of interested persons is to combine trial-specific in-

formation with popular health-related information or free screening services.

The development of an advisory committee con- sisting of both patient and nonpatient representa- tives of the group to be recruited for the clinical trial can provide valuable information specific to the target group. Identification of what motivates patients to enter (as well as not enter) a clinical trial can be one of many areas addressed by the advisory committee. This committee can be apos- itive force to communicate the importance of clin- ical trials research and the need to include diverse groups targeted as the study sample.

It has been suggested that there is a distrust of the "powerful" professional staff by the "power- less" patient. A strategy to counteract this percep- tion is to include minority persons in the clinics as professional or support staff. Ensuring that some staff are fluent in the language of the designated minority will improve communication about the clinical trial. Providing appropriately translated lit- erature, videos, and posters is effective. However, bilingual does not always mean bicultural. A staff that is sensitive to the culture and beliefs of the targeted populations' culture will produce sensitive translations and other recruitment materials. Translation does not always mean transposing in- formation into a foreign language. It may mean putting the information into the English used and understood by the persons being recruited.

The costs of participation in clinical trials is pro- hibitive to those without adequate insurance or with limited resources. "Routine medical care" is not meaningful or relevant to someone who has little or no insurance coverage. Exploration of col- laboration with laboratories and clinics who will provide services for reduced rates for special pop- ulations on studies is recommended.

The provision of a stipend can be a powerful incentive to offset the medical and nonmedical costs of participation. However, investigators need to be aware of possible ethical issues regarding the ability of an economically disadvantaged person to freely choose to enroll in a study that offers a fi- nancial incentive. The incentive cannot be viewed as coercive.

The access to and availability of services as well as the cost of transportation to and from clinic visits can be a factor affecting trial recruitment. In many rural areas, if transportation is available, pa- tients may take most of the day getting to and from

128 McCABE, VARRICCH|O, AND PADBERG

a clinic visit. Having a nurse or study staff member available at a convenient church or school may encourage adherence to study requirements and cause the least disruption of family schedules. The use of a shuttle bus can bring patients from areas that do not have available transportation. The use of the US Post Office to deliver drugs can be ex- plored. A working arrangement with a local phy- sician or outreach program could reduce travel for laboratory work or other interim monitoring activ- ities.

Patients have stated that clinic schedules are only convenient for clinic staff. Patients and fam- ily members may not have "paid leave" from work. Some evening or weekend hours may cause the least disruption of work and home schedules thereby making participation feasible and more at- tractive for the SED.

If study requirements cause patients to spend an extended period of time at a clinic, the provision of free child care and light meals can make it easier to comply with extended clinic appointments. A source of support for these services should be iden- tified as part of the feasibility estimate for the clin- ical trial.

A method to increase communication and trust between the hospital/clinic and the targeted popu- lation is to encourage administrators of hospitals or clinics to become involved in outreach efforts to- ward the community special populations. The sponsoring of Little League teams, participation in school or church fairs, or becoming a patron of community and cultural events can develop strong links for future interaction and communication. This assists in removing the distrust or suspicion of the medical establishment and may lead to in- creased participation in clinical trials.

For those designing protocols in this era of a shrinking health-care dollar, eligibility criteria should be as nonrestrictive as possible while main- taining scientific relevance. All required labora- tory and follow-up visits are kept to a minimum to avoid unnecessary costs or inconvenience to both patient and staff.

Opportunities for public recognition at confer- ences or professional dinners is reinforcing and may be the only external "reward" received, par- ticularly for physicians in private practice. Future patients may be attracted to these physicians be- cause they show a motivation and interest in na- tionally approved cancer research programs, z~

Recognition manifests respect and gratitude to pa- tients and staff for persistence and compliance throughout the required months and years of test- ing and follow-up.

Recruitment to Prevention Trials

Although the strategies discussed have been tar- geted toward recruitment to treatment clinical tri- als, many of these suggestions are appropriate for use in prevention trials. However, there are some additional issues for consideration with prevention trials that relate to trial goals and their impact on low SES/minority issues. These unique differences deserve attention.

Prevention trials differ from treatment trials in three primary ways: (1) the focus is on a cancer- free population; (2) the study is dependent on the recruitment of thousands of participants to each trial; and (3) the study's success requires compli- ance with the protocol for many years. Because of these differences, the prevention team needs to use unique, often creative strategies to meet recruit- ment and compliance goals. This is true in any recruitment efforts to prevention trials. It is a greater problem with special population groups.

When the prevention studies are presented to low-income populations, the team must realize that the accomplishment of daily needs may supersede the planning for future, sometimes very remote, risk of disease. 27 Clinical sites that plan to accrue to chemoprevention trials need to seek additional resources for detailed accrual/adherence sugges- tions and costs.

SUMMARY

Clinical trials are vital for the development of state-of-the-art cancer prevention and treatment. A goal for trial recruitment should be to have a rep- resentative sample of the total population by gen- der, race, culture, ethnicity, and socioeconomic status as appropriate. Increased sensitivity to the unique barriers and access to care issues required to achieve a representative sample are necessary. Knowledge and understanding of recruitment problems and strategies to resolve them are devel- oping; however, much more is needed before we can fully address and resolve all of the relevant issues. Nurses have a key role in identification, education, and recruitment of special populations including the SED to clinical trials.

ECONOMICALLY DISADVANTAGED AND CLINICAL TRIALS 129

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