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Evaluation of Factors Affecting Awareness of and Willingness to Participate in Cancer Clinical Trials

From the University of California Davis Cancer Center; The Center for Health Services Research in Primary Care, UC Davis Medical Center, Sacramento; the Cancer Information Service/Northern California Cancer Center, Fremont; Association of Northern California Oncologists, San Rafael; and the Veterans' Administration of Northern California, Martinez, and Mather AFB, CA

Address reprint requests to Primo N. Lara Jr, MD, University of California Davis Cancer Center, 4501 X St, Suite 3016, Sacramento, CA 95817; e-mail: primo.lara{at}ucdmc.ucdavis.edu

	ABSTRACT

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PURPOSE: Annually, only 3% of patients participate in cancer clinical trials (CCTs). Barriers to accrual include lack of CCT awareness and uncertain third-party payer coverage. In January 2002, a California law (Senate Bill 37 [SB37]) required all third-party payers to reimburse patient care costs related to CCTs. We evaluated the level of awareness of patients and/or their family members/friends regarding CCTs and SB37.

METHODS: We used both a written survey for patients and/or their family members and friends seen in oncology clinics, and a verbal telephone version for Cancer Information Service callers. We tested for correlations between CCT awareness and SB37 knowledge, and willingness to participate in CCTs.

RESULTS: Of 1,188 respondents, 59% were aware of CCTs, 19% knew of SB37, and 36% were very likely to consider a CCT. There were significant positive correlations between CCT awareness and willingness to participate (P < .001, Spearman), and between SB37 knowledge and willingness to participate (P = .001, Pearson ²). Reduced awareness was seen in respondents who were either black or African American (odds ratio [OR], 0.44; P = .004), Hispanic (OR, 0.56; P = .03), had an annual income less than $25,000 (OR, 0.38; P < .001), or had less than a college degree (OR, 0.12 to 0.53; P < .001 to .013). Reduced willingness to participate in CCTs was seen in black or African American participants (OR, 0.38; P < .001), Asians (OR, 0.44; P < .006), or respondents aged 18 to 24 years (OR, 0.35; P = .002).

CONCLUSION: These results support the hypothesis that improving CCT awareness and SB37 knowledge especially among lower income, less educated, and minority patients, may potentially overcome barriers to participation and subsequently increase accrual in California.

	INTRODUCTION

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Based on our enhanced understanding of tumor biology, new anticancer therapies are being developed at an increasing pace. Early-phase (I and II) clinical trials are critical in evaluating the safety and efficacy of these novel therapies in cancer patients. A recent National Cancer Institute (NCI) study reported that annually, less than 3% of adult cancer patients in the United States participate in NCI-sponsored clinical trials—a rate that has not improved in more than two decades.¹,² This contrasts with pediatric oncology, where standard practice includes patient enrollment into peer-reviewed, cooperative group clinical trials, resulting in an accession rate exceeding 60%.³-⁵ Low accrual rates clearly have a negative impact, often prolonging the duration of trials, delaying the analysis or publication of important results, and/or leading to early closure and failure of important studies.⁶,⁷ Poor accrual into early-phase clinical trials markedly delays drug development and subsequent patient access to potentially active new agents. Understanding the reasons behind low patient accrual rates and the development of strategies to overcome barriers is essential to increase participation in clinical trials.⁸,⁹ Unfortunately, prospective data addressing this issue are limited.

A recent summit on clinical trials accrual¹⁰ cosponsored by several cancer organizations identified misperceptions and lack of communication as barriers to study participation. The summit participants, comprising a diverse group of patient advocates; physicians; nurses; data managers; and representatives from third-party payers, and industry and government agencies concluded that the public lacked general knowledge about clinical trials, including their potential benefits to individual patients and society. In addition, the participants noted a "general lack of coordination of messages, resources, information, help, and support" regarding the clinical trials process, which could lead to misperceptions and misinformation.

A Harris Interactive Poll recently highlighted a lack of awareness among cancer patients of the existence of clinical trials as a treatment option. The poll showed that 85% of almost 6,000 cancer patients surveyed did not consider participating in a trial because they did not realize that clinical trials participation was an option available to them.¹¹ The majority of responses from both cancer patients and the general public, however, suggested a generally positive view of clinical trials; most believed that participation in a trial would allow them better treatment in addition to benefiting others. Still, the fact remains that even among cancer patients who were aware of trials, the majority (71%) did not participate in them.

In a prospective study of patient accrual patterns in cancer clinical trials by University of California Davis (UCD) investigators, fear of insurance denial was a concern to patients considering trial participation.¹² Despite the fact that only 8% of patients failed to participate because of denial of coverage by third-party payers, patients with nongovernment insurance were found to be statistically less likely to participate than those with government insurance. A hypothesis generated by this study was that patients with private insurance perceived that they might not be adequately covered by their third-party payer for clinical trial participation. This hypothesis is consistent with the results of the Harris Interactive Survey, which also demonstrated that concerns about insurance denial were a primary barrier to participation.

In response to growing concerns about reimbursement for the costs of participation in clinical trials, several states, including Maine, Maryland, and Arizona, have enacted laws requiring third-party payers to cover routine patient care costs associated with clinical trials. In 2000, California became only the 14th state to pass legislation that all third-party payers, including MediCal (California's Medicaid program), reimburse patient care costs related to all phases of cancer trials. Senate bill SB37, authored by California State Senator Jackie Speier (D-Hillsborough), was signed into law by then-governor Gray Davis on August 9, 2001. It formally took effect on January 1, 2002. The law mandates that Californians with cancer who are accepted onto any phase of a federally approved clinical trial of an investigational drug, device, or procedure, can rely on coverage from their third-party insurers for services they would have otherwise received for standard cancer treatment. To the best of our knowledge and after querying the California Department of Managed Health Care, we found that no specific state-funded advertising program was conducted following passage of this bill into law.

Although efforts requiring third-party payers to assume costs related to early-phase trials are encouraging, their impact on patient accrual remains unstudied and therefore uncertain. The perception of uncertain third-party payer coverage has been shown to be a barrier to accrual for all phases of clinical trials.¹² Despite evidence to the contrary, in one study, only 21% of the patients who enrolled in trials reported difficulty obtaining insurance coverage. We hypothesized that disseminating information on cancer clinical trials and reimbursement (ie, SB37 mandate) to cancer patients and their family members or friends would help overcome a major barrier to participation in early-phase clinical trials. Funding from a unique public-private partnership, brokered by the NCI and Friends of Cancer Research with six pharmaceutical companies, provided an opportunity to begin testing this hypothesis.

The first phase of our project, reported herein, involved gaining a better understanding of the level of awareness cancer patients and/or their family members or friends possessed regarding cancer clinical trials and attendant reimbursement issues, including SB37. Family members or friends were also surveyed because of recent data from Blackhall et al showing that particular groups were more likely to hold a family-centered model of medical decision making rather than the patient autonomy model. These investigators concluded that "physicians should ask their patients if they wish to receive information and make decisions or if they prefer that their families handle such matters."¹³ Because of the broad influence of family members or friends in the care of the oncology patient, we elected to include them in our survey. We present the results of an "awareness and willingness survey" of cancer patients and their family members or friends who were either seen for the first time in an oncology-based clinic within the catchment area of the UCD Cancer Center (UCDCC), or who had telephoned the Cancer Information Service (CIS) phone bank from the UCDCC or UC San Diego (UCSD) Cancer Center catchment areas.

	METHODS

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In an effort to elicit greater community involvement, we created partnerships with the CIS, the Association of Northern California Oncologists (ANCO), and the Veterans' Administration of Northern California (VA). The partners held monthly steering committee meetings to direct the course of the instrument design and to ensure face validity. A survey instrument was designed for new cancer patients (and their family members/friends) being seen at a cancer facility, assessed for face validity, and then pilot tested for readability and comprehension in ten cancer patients being seen at the UCDCC and at the Sutter Cancer Center, an ANCO affiliate. Patients were either newly diagnosed with cancer and were first time visitors to the cancer treatment facilities surveyed, or had a prior history of cancer but are presenting with a new stage of their disease. Feedback from the pilot test suggested operational feasibility of the written instrument. Data were collected from a nine-county region (Sacramento, El Dorado, Placer, Amador, Yolo, Sutter, San Joaquin, Solano, and Yuba counties) within the catchment area of the UCDCC. The CIS, under the direction of the steering committee, developed a verbal, telephone version of the instrument to simultaneously accrue a cohort from the UCSD Cancer Center catchment area in the Southern California counties of San Diego, Imperial, and Riverside. These counties represented a geographical area remote from UCDCC and were to serve as a control population for a future comparative analysis of clinical trial awareness following an informational campaign in the UCDCC catchment area (ie, the intervention phase of the project). In this report, we merged the data from Southern and Northern California cancer patients and their family members/friends to provide an indication of baseline awareness of and willingness to participate in cancer trials.

Approval was obtained from UCD and from the CIS Institutional Review Boards. Surveys commenced on October 1, 2003. Survey data collection was conducted through a network organized specifically to gather baseline data on clinical trial and SB37 awareness. The UCD-VA-ANCO groups utilized a printed questionnaire, and the CIS collected data by way of telephone interviews. Survey data (completed questionnaires and/or telephone interviews) were collected either by electronic or postal means through designated site coordinators every 4 weeks and were then transmitted to a programmer. Analytic data sets were prepared by the programmer and transmitted to the Division of Biostatistics via secure file transfer protocol (FTP), with codebooks for each data set. Each subject was assigned a study ID; analytic data sets used only study ID and contained no personal identifiers.

The overall goal of our project was to increase early-phase clinical trial accrual through interventions designed to increase awareness about clinical trials and systems of reimbursement. Project evaluation had two components: (1) assessment of the impact of an informational intervention on awareness of key participants in the enrollment decision process, and (2) assessment of the interventions' effect on early-phase trial accrual at UCDCC. All analyses were carried out using SAS, S-Plus, and SUDAAN. All statistical tests were two-sided at a significance level of .05. We constructed summary measures of the six questions on the survey about participants' level of knowledge about clinical trials, based on a theoretical framework that was supported by the data. We anticipated that more people would be familiar with the term and general purpose of a clinical trial than would know the details of funding under California's new state law. Thus, we planned a hierarchy of summary measures: those who had general awareness, and a subset who reported additional detailed knowledge. We characterized awareness as a dichotomous variable, constructed by combining responses from two questions in the awareness survey. Respondents were considered to be "aware" of clinical trials if they (1) had heard of a clinical trial and (2) agreed that a clinical trial tests how safe and useful a new drug is against cancer and other diseases. We further identified those persons we thought to be knowledgeable about cancer clinical trials as those persons who, in addition to (1) having heard of a clinical trial and (2) agreeing that a clinical trial tests how safe and useful a new drug is against cancer and other diseases, also (3) agreed that the sponsor pays for the new drug being tested and all other cost are picked up by the insurance company, (4) knew about the California Law that makes insurers pay most of the costs for cancer patients involved in clinical trials, (5) thought of a clinical trial as a test of a new drug or treatment, and (6) did not think a clinical trial is a legal or court case/trial. We summarized awareness and knowledge both by dichotomy and by number of the concepts correctly answered. Standard psychometric approaches assessed individual items and instrument readability, and discrete data summaries were used to assess conceptual hierarchy. Cancer patient and family member/friend responses were pooled to represent the awareness of lay people affected by cancer.

Sample sizes were calculated based on an estimate of approximately 3,500 new cases of cancer diagnosed annually in the Northern California region and a desire to reflect the awareness level of cancer patients and their family members or friends. Power for testing the hypotheses was based on the assumption that a global measure of awareness of and willingness to participate in clinical trials will have approximately a normal distribution and that samples from different regions or from pre- and postintervention periods are independent. It was estimated that a sample size of 1,000 respondents (750 from the UCDCC area and 250 from the control UCSD area) was required for each of the pre- and postinformational campaign periods to have 80% power to detect an improvement in mean awareness by a standard deviation (SD) of 0.125.

We probed for statistical correlations between awareness of cancer clinical trials/SB37 and willingness to participate in such trials, using Spearman's correlation and Pearson's 2 statistics. Logistic regression analysis was also performed to determine whether certain demographic characteristics would predict for awareness or willingness to participate. Significance was defined as P < .05.

	RESULTS

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The baseline awareness survey was completed on April 28, 2004. A total of 1,325 surveys were collected, of which 1,188 were successfully completed: 1,012 from the UCDCC area and 176 respondents from the UCSD area. The only differences noted between in-person and telephone respondents were that a higher proportion of telephone respondents were Hispanic, possibly reflecting local demographics in San Diego.

Demographics
Respondent demographics are summarized in Table 1. In response to the initial query "At today's clinic visit, you are..." 601 respondents (51%) stated that they were "a patient"; 540 (45.5%), "a family member or friend"; 21 (1.8%), "general public"; and 26 (2.1%), "other" or did not report. Due to errors in photocopying the surveys, only 50% of the surveys included a question on sex; those surveys collecting information on the respondent's sex showed that 392 respondents (66%) were female. Six hundred eleven persons (51%) reported that they were 55 years or older. All respondents were asked to report their ethnicity and could check all ethnic statuses that applied. Respondents' overall ethnicity profiles corresponded to those expected within the region—897 respondents were white, 85 were black or African American, 84 were Hispanic, and 68 were Asian. The remaining reported their ethnicity as "other" or declined to state.

Awareness Survey Results
The results of the awareness survey are summarized in Table 2. Eight hundred twenty-four respondents (69%) stated that they had heard the term "clinical trial," and only 79 (7%) were unsure about what the term meant or did not respond to the question. When asked to define what a clinical trial was, given a set of responses, 779 stated that a clinical trial was a new drug treatment, 369 said it was an experiment, 308 stated it was a test or procedure in clinic, 185 responded that it was a cancer treatment, and 24 characterized a clinical trial as a legal or court case. When asked to report their level of agreement with the statement, "a clinical trial tests how safe and useful a new drug is against cancer and other diseases," 861 (73%) respondents agreed, 36 (3%) disagreed, and 291 (24%) were unsure or had no response.

Six hundred ninety-five (59%) respondents recognized the term "clinical trial" and knew the definition of a clinical trial, and those respondents were labeled as "aware." Only 61 of respondents (5.1%) met the entire knowledgeable criterion. Considering awareness and knowledge as score variables, we saw a mean awareness score of 1.4 with an SD of 0.76, and a mean knowledge score of 3.6 with SD of 1.31.

There was a statistically significant association between the level of "knowledgeable" and having "willingness to participate" in a cancer clinical trial (r = 0.304; P < .001; Spearman correlation). The more knowledgeable the respondent, the more willing the respondent was to participate in a clinical trial. Similarly, there was significant association between respondent awareness and willingness to participate (r = 0.23; P < .001; Spearman correlation). In this analysis, the more aware the respondent was about clinical trials, the more willing he or she was to participate in them. There was also a significant association between willingness to participate and SB37 knowledge (P = .001; Pearson 2).

Logistic regression analyses of clinical trial awareness and willingness to participate in relation to the variables of income, ethnicity, educational attainment, and age were performed. The results of these two models are summarized in Tables 3 and 4. Reduced awareness of clinical trials was seen in respondents who were black or African American (odds ratio [OR], 0.44; P = .004), and Hispanic respondents (OR, 0.56; P = .03), relative to whites, had an annual income less than $25,000 (OR, 0.38; P < .001) relative to incomes ranging from $50,000 to $74,999, or had less than a college degree (OR, 0.12 to 0.53; P = .13 to < .001), relative to those with a postgraduate degree. Reduced willingness to participate in clinical trials was seen in respondents who were black (OR, 0.38; P < .001) and Asian (OR, 0.44; P < .006) relative to whites, or between 18 to 24 years of age (OR, 0.35; P = .002) relative to those between 55 and 64 years of age.

Respondents with high school diplomas (P .001) or less education (p .001) answered fewer questions correctly on average than did the group with the highest education in multivariate analysis for knowledge of clinical trials adjusted for other demographic variables (results presented in Table 5). Significantly lower knowledge scores were also found in the lowest income group (P = .04), among African Americans (P .001), and among those younger than 18 years or older than 75 years (P = .01; P = .02; respectively). Demographic variables accounted for 13% of the variation in knowledge about clinical trials, suggesting that other personal experiences or characteristics play a role as well. Generalized linear model findings were similar (results not shown).

	DISCUSSION

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION Authors' Disclosures of... REFERENCES

 
We undertook a survey study of patients and their family members/friends to assess levels of awareness and willingness to participate in cancer clinical trials. Of 1188 surveys from respondents that could be evaluated, 69% had heard of a clinical trial. More than half of all respondents were not sure or had not heard of policies about third-party reimbursement set forth under SB37. We also found that reduced levels of awareness were especially apparent in respondents of black or Hispanic ethnicity and in persons reporting lower levels of income (less than $25,000 annually) and education. Reluctance to participate in cancer clinical trials was also found in persons reporting black or Asian ethnicities and in younger respondents (ages 18 to 24 years). Although not surprising, these results are among the first to be collected prospectively in a study adequately powered to assess awareness of clinical trials and designed to develop methods to overcome barriers to accrual.

Numerous barriers to cancer clinical trials have been previously described.¹⁴ However, prospective data have been limited, particularly with regard to patient-related barriers. A Harris Interactive Poll showed a lack of public awareness of cancer clinical trials as a therapeutic option. Our study indicates that most respondents (69%) had heard of clinical trials, though most had insufficient knowledge about reimbursement issues and about SB37. Importantly, we demonstrated that awareness of clinical trials and SB37 was associated with willingness to participate in such trials. This observation provides the rationale for an informational campaign to increase accrual to cancer clinical trials by making persons more aware of both clinical trials and reimbursement issues.

This study has its limitations. First, our survey findings were derived from a sample of respondents who were not randomly selected, and therefore, our data suffer from biases of convenience sampling and participant self-selection. Second, our observations and survey results generally reflect that of a limited geographic focus in Northern and Southern California. Although the counties surveyed possess great racial/ethnic diversity, our findings can only be generalized to institutions and geographic areas similar to that involved in our study.¹⁵ Third, our survey was conducted in English, and we did not disaggregate results for persons of various Asian or Hispanic ethnic groups in this report. Because our aggregated data do not allow us to account for the range of educational, linguistic, and socioeconomic diversity that exists in these populations more generally, it is not clear whether our findings reflect or are highly generalizable to the greater Asian or Hispanic communities in the Sacramento area or elsewhere.¹⁶ Despite these limitations, our study is among the first large-scale studies of its kind to prospectively assess patient-related barriers to participation in a cancer clinical trial.

Barriers to recruitment of minority populations, in particular, have been found to limit the interpretation and applicability of cancer clinical trial findings.¹⁷-²¹ When a population of potential participants is excluded from research or involved as subjects only in small numbers, scientists and clinicians find it necessary to extrapolate the results of research on other populations or to forego treatment of these individuals and populations altogether.²² To provide state-of-the-art therapy for all persons, attention to differential group access and participation in research is warranted; unfortunately, results of such research remain limited.¹⁶-¹⁸,²³,²⁴ A study on barriers to participation in clinical trials found that 45% of white patients, compared with 31% of African American patients, were willing to participate in a clinical trial (P = .05).²⁵ The investigators also found that more African American patients did not complete high school and had annual incomes less than $15,000. Furthermore, more African American patients believed that God would determine whether they would be cured or would die from their disease as compared with whites. In a multivariate analysis, education, income, and belief that God would determine the patient's outcome also were correlated with a decreased willingness to participate in clinical trials.²⁵ Many of these findings are consistent with our results. Disparities in access to and delivery of health care also further increase the gap in patients' willingness to participate in, and in their overall understanding of, clinical trials. Finally, it is necessary to develop interventions in Spanish and Asian languages to more critically assess knowledge and willingness in the Hispanic and Asian populations.

Adding to variation in patients' experiences with research and health care systems that may impact trust and willingness to participate in clinical trials, patients' concerns about insurance denial have been shown to be a major barrier to trial participation.¹¹,¹² Although some states' efforts requiring third-party payers to assume costs related to clinical trials are encouraging, it is still unclear whether awareness of clinical trials and favorable reimbursement policies will enhance accrual to early-phase clinical trials and help to reduce disparities in access to novel cancer therapies.

The results of our survey provide support for the hypothesis that accrual to early-phase cancer clinical trials may be enhanced by increasing awareness of clinical trials and reimbursement issues (specifically SB37) among cancer patients and their family members/friends in California. In particular, these results suggest that designing tailored interventions that target particular racial/ethnic and socioeconomic groups may enhance those groups' awareness and willingness. Data from our survey have been used to design a multimedia campaign that employs fundamental marketing principles aimed at delivering early-phase trials information (the "product") back to the surveyed population (the "target audience"). As part of this ongoing campaign, minority and underserved populations and their community leaders have been targeted specifically through direct face-to-face interactions within their specific communities and organizations. Following the campaign, the target audience in both Northern and Southern California regions will be resurveyed to assess whether early-phase trials and SB37 awareness has been enhanced by linguistically and community-tailored interventions designed to increase awareness of clinical trials and SB37.

	Authors' Disclosures of Potential Conflicts of Interest

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION Authors' Disclosures of... REFERENCES

 
The authors indicated no potential conflicts of interest.

	NOTES

 
Supported by the National Cancer Institute (Grant R21 CA-03-501), ACS-CRTG#19701CCE (P.N.L.), and the Veterans Administration of Northern California.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

	REFERENCES

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION Authors' Disclosures of... REFERENCES

 
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Submitted May 5, 2005; accepted October 4, 2005.

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