Belief in Research, Religious Coping, and Willingness to Participate in Clinical Trials Among African American Patients With Hematologic Malignancies: A Pilot Study

J Clin Pathways. 2023;9(1):15-21. doi:10.25270/jcp.2023.01.01

The African American (AA) population has a higher incidence and mortality rate for acute leukemia, chronic leukemia, myelodysplastic syndrome, diffuse large B-cell lymphoma, Hodgkin lymphoma, and multiple myeloma than the non-Hispanic White population and other racial and ethnic minority groups.^1-5 Despite great progress in cancer management and our understanding of factors that contribute to racial and/or ethnic disparities in cancer incidence, sparse literature addresses the underrepresentation and willingness to participate in clinical trials among AA patients with these specific hematologic malignancies. In sharp contrast, a growing body of literature references the willingness to participate and cites the many barriers to enrollment in clinical trials among the AA population with solid tumors.

Underrepresentation in clinical trials leads to the nongeneralizability of clinical trial findings, disparities in cancer treatment outcomes and survival compared to other racial and ethnic minority populations, and the absence of predictive biomarkers to identify responders to new cancer therapies.^6-8 Underrepresentation also creates challenges regarding the safety, tolerability, and potential efficacy of new cancer modalities due to tumor biology variations, the metabolism of certain chemotherapy drugs, and drug response differences in the AA population.^8,9

When compared to the non-Hispanic White population, the AA population has a 45% higher probability of death from acute lymphoblastic leukemia, and a 12% higher risk of death from acute myeloid leukemia. AA patients tend to present at a younger age with more advanced-stage disease and have lower survival rates with chronic lymphocytic leukemia.^1-3 Survival is also worse for myelodysplastic syndrome despite having a lower incidence and age at diagnosis.⁴ On initial presentation, AA patients present with more advanced-stage disease and have inferior survival in diffuse large B-cell lymphoma and Hodgkin lymphoma.¹⁰ For multiple myeloma, the risk of disease development is 2 to 3 times higher; however, survival is improved when there is access to care and when novel treatments, such as immunotherapy and stem cell transplantation, are received.^5,8,11,12 Even so, approximately 49% of AA patients with multiple myeloma are less likely to receive stem cell transplantation and have the lowest utilization of immunomodulatory drugs, such as lenalidomide.^13,14

Factors that may be attributed to inferior outcomes among AA patients with hematologic malignancies include higher comorbidities and lower socioeconomic status disease heterogeneity, social determinants such as access to medical care and clinical trials, and systematic bias within the US health care system.^7,15-17 Barriers to enrollment in clinical trials are well documented. Reasons may include cost and strict eligibility criteria, negative perceptions, and lack of trust in the medical system.^7,18 For example, deep-rooted negative beliefs and fears related to historical experiences dating back to the era of slavery and awareness of the Tuskegee Syphilis Study in the 1930s have been well-cited as potential barriers to clinical trial enrollment.^19,20 Therefore, it is not surprising that the recruitment of AA patients to clinical trials remains a significant challenge, and the impetus to improve their participation—as well as the enrollment of other racial and ethnic minority groups—into clinical research studies remains a national priority.

Given the disparity in outcomes for various hematologic malignancies among the AA population, it is particularly critical to actively recruit this population into clinical trials addressing these malignancies.¹⁶ Of the 3% of AA patients who enroll in clinical trials, it is unclear what fraction comprises those with hematologic malignancies.²¹ It is also unknown if AA patients with hematologic malignancies are just as likely to participate in clinical trials as those with solid tumors. In addition, the lack of literature addressing the underrepresentation of this population creates a problem for researchers with limited knowledge about their beliefs in clinical trials and the circumstances under which they would be willing to participate. Knowing that clinical trials are necessary for improving cancer control, a better understanding of the beliefs and willingness of this population to participate in future studies is critically important.²²

Literature shows that beliefs are shaped by culture, environment, and experiences, and that beliefs drive attitude and inform actions or behavior.²³ Therefore, the primary objective of this pilot study was to examine the relationship between belief in research and willingness to participate in clinical trials. The study also was conducted to determine the feasibility of recruiting the AA population and to generate data to aid in designing future large-scale studies that will recruit AA patients with hematologic malignancies into clinical trials. Determining the moderating effect of religious coping on the relationship between belief in research and willingness to participate was also an aim of this study. A review of the literature revealed that the concepts of belief in research, willingness to participate in cancer clinical trials, and religious coping have not been studied in a population of AA patients with hematologic malignancies.

This study took place in an academic medical center in the southeastern part of the US in a city with an AA population of 107,182.²⁴ A convenience sample of 30 adult AA patients with any hematologic malignancy was determined to be sufficient for estimation of the effects and associations. Eligibility criteria included being in the AA population; age ≥18 years; diagnosis of hematologic cancer at stages 0, I, II, III, or IV; ability to speak and write English; and under the care of an oncologist at the study site. Patients who were newly diagnosed with a hematologic malignancy, unable to read English, and under 18 years of age were excluded from the study. In addition, because of COVID-19 restrictions on gaining access to patient populations, an oncology nurse navigator, who the researcher trained on this Institutional Review Board-approved study protocol, identified, recruited, obtained consent from, and collected the data from all study participants. Data were collected from March 2021 through April 2021.

This descriptive, cross-sectional research study used 3 instruments and a demographic questionnaire to collect data on belief in research, willingness to participate in clinical trials, and religious coping.

Belief in the research was operationalized with 1 question developed by the researcher: “Do you believe cancer research can help treat your cancer?” Patients were asked about their willingness to participate in a clinical trial based on three conditions: (1) the clinical trial would improve the length of their life, (2) the clinical trial would improve quality of life (QOL), and (3) the clinical trial would help others. These items were combined to measure patients’ willingness to participate in clinical trials to provide a score with a possible range of 3 to 12 points.^25,26 Religious coping was operationalized with the validated 14-item Brief Religious Coping Scale (RCOPE).²⁷ Responses to belief in research, willingness to participate, and religious coping were measured using a 4-point Likert scale (1 = not at all, 2 = somewhat, 3 = quite a bit, and 4 = a great deal).

Statistical significance was assessed using an α level of 0.05. Descriptive statistics were determined on all variables. Potential demographic or Brief RCOPE (positive or negative) confounders of the association between belief in research and willingness to participate were examined initially. For potential categorical confounders, differences in the median belief in research score between groups were analyzed using a Kruskal-Wallis test. For potential continuous confounders, simple linear regression with belief in research as the outcome and the potential confounder as the independent variable were used.

To examine whether belief in research was associated with willingness to participate, a simple analysis of variance (ANOVA) was used with the willingness to participate as the outcome and belief in research as the main independent variable. The demographic variables that were examined as potential confounders were also examined by a simple ANOVA, for categorical or linear regression models, as continuous variables. A full analysis of covariance was used to examine the potential association between belief in research and willingness to participate, controlling for all demographic and Brief RCOPE covariates or confounders.

A total of 31 respondents enrolled and were included in the analysis. Of the 31 participants, 15 were men (51.7%) and 14 were women (48.2%), the average age was 63 years (standard deviation [SD] = 10.2, range 35–81 years), and most (80.6%) identified themselves as AA patients. All study participants were born in the US, and 19.3% had leukemia, 22.6% had lymphoma, 54.8% had multiple myeloma, and 3.2% had a myelodysplastic syndrome. There was only 1 individual who had a myelodysplastic syndrome, so this individual was combined with the leukemia individuals in subsequent analyses. More than half of the participants (54.7%) had some form of college education, while 32.2% had less than a high school education. Most of the participants (n = 23; 74.1%) did not report income, and only 1 participant (3.2%) was uninsured; thus, income and insurance status were excluded from further analysis. The majority (80.6%) identified their religion as Baptist. Table 1 gives the descriptive statistics for all variables as well as the results examining the potential association of confounders with belief in research.

More than half of the participants (63.3%; n = 19) reported that they believed a clinical trial could help treat their cancer, and 61.3% (n = 19) indicated they were willing to participate if it could ultimately help other people in the future. Nearly three-fourths (74.2%) reported being aware of clinical research in general; however, most (74.2%) mentioned that their physician did not share clinical trial information related to their diagnosis. Only 1 participant (3.2%) was enrolled in a clinical trial. Fear of clinical trials and lack of trust in research was reported in 16% and 8% of the participants, respectively.

When examining potential confounders, only education was associated with belief in research. Table 2 gives the results of the association of belief in research with the willingness to participate and the associations of the potential demographic and Brief RCOPE covariates and confounders. In both simple models and the full model controlling for demographic and Brief RCOPE covariates, there was no significant association with belief in research and willingness to participate. However, willingness to participate scores were higher among subjects who believed in research quite a bit compared to other belief groups. No demographic or Brief RCOPE variable was significantly associated with willingness to participate.

Table 3 summarizes the descriptive statistics for willingness to participate. Results showed a mean willingness to participate score of 9.16 (SD = 3.67) and a high median score of 12.0, indicating that participants had a high willingness to participate in clinical trials. Most of the participants were willing to participate in a clinical trial if it would improve the length and QOL (n = 18; 58.0% for both items), while 61.3% (n = 19) stated they would participate for altruistic reasons. The Cronbach’s alpha for the overall willingness to participate scale used in the study was 0.98 (lengthen life = 0.96; QOL= 0.95; help others = 0.99), indicating a high level of reliability.²⁸

Despite the therapeutic advancement in cancer treatment throughout the years and improved outcomes, disparities in incidence and survival still exist among AA patients with certain hematologic malignancies. Strategies are necessary to eliminate the disparities. It is imperative that we address the sparse data relating to the participation of this population in clinical trials; thus, the focus on this group of patients in the era of health disparities and inequities increases the significance of the present study.

We enrolled 31 patients in the study, suggesting that it is feasible to recruit AA patients with hematologic malignancies. The mean age of participants was 62.9 years (SD = 10.24), which is comparable to what has been reported in previous studies with AA cancer patients.²⁹ Multiple myeloma was the most represented disease and is one of the most commonly diagnosed hematologic malignancies among the AA population, with an incidence rate that is 2 to 3 times higher than that observed in the non-Hispanic White population.^5,16

The educational level among the sample was varied. Most participants had some form of college education, while a nearly equal proportion had less than a high school education. More than half of the participants reported that they believed in clinical trials, with results that showed a significant association between education and belief in research scores. Most importantly, those with some college education had higher belief in research scores than those with less than a high school education. Participants with higher belief in research scores were more willing to participate in clinical trials for personal or altruistic reasons. Those with lower belief in research scores and education were less willing to participate in clinical trials.

It is feasible that those with higher education levels were more likely to perceive the benefits, take cues to action, and seek clinical trial knowledge than those with less than a high school education. It is also possible that those with less than a high school education may have been less aware and/or had less access to clinical trials; thus, these individuals were less inclined to participate in clinical trials than those with higher education.

Together, these results suggest that factual knowledge can influence an individual’s beliefs and intentions toward a behavior, in this case, the act of participating in a clinical trial. The results also suggest that education related to clinical trial participation may positively influence an individual’s beliefs and perception of clinical trials. Therefore, targeted and tailored educational approaches are necessary to inform patients about clinical trials and enhance future clinical trial enrollment among the AA population.

Nearly three-fourths of the participants reported being aware of a clinical trial, yet a high proportion did not receive clinical trial information from their physicians. Physicians are critical influencers for patients’ participation in clinical trials; therefore, results from the study may reflect a physician’s lack of awareness about the availability of pertinent clinical trials, a low number of open trials at the institution, an insufficient level of research staffing to assist with the conduct of clinical trials at the institution, physician bias toward patients, or a given patient’s failure to meet the eligibility requirements.

There are many other factors that may negatively or positively influence participation in clinical trials. These may include, for example, the level of support from family and friends, job obligations, logistics of getting to the research site, perceived benefits of the clinical trial, age,income, treatment side effects, decisions related to complex cancer treatment, doctor–patient relationships, and doctors’ influence.^17,26,29-31 Although in this study religious coping did not moderate the relationship between belief in research and willingness to participate, the relationship between religious coping and the willingness to participate in a clinical trial should be studied further. The practice of religion is a coping strategy that the AA population commonly use to manage stressful situations.³² The goal of a coping strategy is to change or decrease the nature of the situation that is causing the stress or to change how one feels and thinks about the stressful situation to improve one’s response.³³ Religious coping is even more compelling when facing a cancer diagnosis that has many uncertainties throughout the trajectory of the illness.

While this study cannot distinguish among all these potentially contributing factors, together our results suggest that strategies to improve clinical trial enrollment need to be multifaceted. The results further indicate that awareness changes attitudes toward and enrollment in clinical trials.³⁰ If patients are aware of clinical trials at the time of diagnosis, there is a possibility they may enroll; however, patients may be unwilling to participate in studies they do not know much about.^30,31 One way to address this problem is to embed clinical trials into the clinical workflow at the point of treatment decision-making, allowing oncologists to select a patient to be screened for a trial directly from the oncology pathways tool.³²

This study did not uncover patient information sources about clinical trials. Other than physicians, AA patients with cancer rely on other sources of information, such as newsletters, workshops, friends, and family, as well as nurses.^26,33 Nurses are at the forefront of patient education and are experts in establishing trusting relationships with patients and families. Thus, trust may also be a key factor that can be used to promote a positive attitude toward enrollment of patients in clinical trials. Actionable opportunities, therefore, exist for future researchers to enhance a study’s success by collaborating with oncology nurse navigators who can help identify potential candidates, increase patient awareness, and assist in the enrollment of patients in clinical trials.

This study utilized a homogenous convenience sampling approach that focused exclusively on AA patients with hematologic malignancies from a single institution. Even though it was advantageous to conduct the study at a single institution, it limited understanding the concepts among patients from other institutions and geographic locations. In addition, these findings cannot be generalized to AA patients with solid tumors, and the small sample estimates are not reflective of other racial and ethnic minority groups with hematologic malignancies.

Comparisons of the study concepts among AAs with hematologic malignancies in the community and rural settings, as opposed to an academic medical center, should be considered for future research. The promotion of clinical trials in these cancer settings could help build trust between patients and health care providers. It also could help minimize the logistical burden that rural patients may encounter when they participate in a clinical trial. Furthermore, future multiinstitutional studies are warranted with a heterogeneous sample population to further understand the associations between belief in research, religious coping, and willingness to participate.

This study also used a quantitative research methodology that allowed for objectivity and accuracy. However, this approach limited the capture of shared realities and detailed contextual descriptions from the study participants, which might have provided insights useful for the planning of future studies. Future researchers may want to consider a mixed methodology approach to gain a deeper understanding of the concepts being studied here.

The AA population has a higher probability of death from acute and chronic leukemia, diffuse large B-cell lymphoma, Hodgkin lymphoma, multiple myeloma, and myelodysplastic syndrome than the Hispanic and non-Hispanic White populations.² To improve cancer outcomes, the enrollment of the AA population in cancer clinical trials must increase. Preliminary results from this pilot study may help in the design of future studies to help increase enrollment and overcome barriers to clinical trial participation.

Marjorie E Petty, PhD, MSN¹; Cynthia Chernecky, PhD, RN, AOCN, FAAN¹; Irina Shishkina, BSN¹; Nita Maihle, PhD²; Jean Pawl, PhD, RN, OCN, CNE¹; Jennifer L Waller, PhD³; Lufei Young, PhD, RN, APRN-NP¹; Julie Zadinsky, PhD, MSS, RN, CIP¹

Affiliations: ¹College of Nursing, Augusta University, Augusta, GA; ²Departments of Medicine, and Cell & Molecular Biology, The University of Mississippi Medical Center, Jackson, MS; ³Department of Population Health Sciences, Division of Biostatistics and Data Science, Augusta University, Augusta, GA

Address Correspondence to: Marjorie E Petty, PhD, MSN

1120 15th St

Augusta, GA 30912

marjorie@petty.tv

Disclosures: The authors disclose no financial or other conflicts of interest.