The Impact of Non-Clinical Factors in Clinical Trial Enrollments of Patients with Hematologic Malignancies

Introduction

The improvement of care and advancement of treatment options is heavily reliant on the success and diversity of clinical trials (CTs), yet data suggests that only 3-9% of patients with a cancer diagnosis participate in CTs. We sought to evaluate reasons for declining participation in CTs among patients with hematologic malignancies within our medical center. Our primary objective was to assess the prevalence of non-clinical factors in patients contributing to the lack of participation compared to those who agreed to participate. The secondary objective was to identify the reasons noted by patients for declining trials.

Methods

We conducted a retrospective chart review of adult patients with hematologic malignancies who were offered a clinical trial from 2016-2020. Eligible patients were identified through review of Cancer Center Clinical Trials Office screening logs. We collected data relative to: disease, sex, age, race and ethnicity, English as a first language, marital status, caregiver support, level of education, type of insurance, trial phase, and trial indication. The data was compared between patients who refused participation versus those who agreed to participate. Descriptive statistics, chi-square analysis, and multivariate logistic regression were used to interpret the data with IBM SPSS Statistics.

Results

Of patients diagnosed with hematologic malignancies and offered a CT from 2016 to 2020 at our center, 136 signed consent and 125 declined participation. The sample was predominantly older with a mean patient age of 60.9 in those who signed ICF and 61.9 in those who declined participation (Table 1). Males and non-Hispanic white patients encompassed over half of the sample in each group. Multiple myeloma was the most common diagnosis among either group. Trials offered were predominantly phase 2 or 3 and for varying disease states. We found that patients who were divorced (P = 0.024), did not have caregiver support (P = 0.005), and did not speak English as their first language (P = 0.004) were more likely to decline CT participation (Table 2). The most common reasons that patients cited for declining participation were: preference for another treatment option, distance for travel, and concerns for transportation (Table 3).

Conclusion

In this retrospective analysis evaluating reasons behind CT refusal in patients with hematologic malignancies at our center, we found that being divorced, not having defined caregiver support, and not speaking English as the first language made patients more likely to decline a CT. Our sample displayed greater diversity in comparison to the national averages for cancer CT participation despite the predominance of male and non-Hispanic white patients within our sample. This may be representative of the population our center serves. The significance of marital status and caregiver support suggests that support systems are integral in the decision-making process for CTs. Furthermore, the role of divorce in declining trials may be indicative of familial motivation or spousal influence. The significance of English as a first language is notable as our center utilizes an oral translation for informed consent with a short form signature. This suggests that a full translation of CT documents may be beneficial to enrollment. Logistical concerns were frequently cited as a reason for declining, which should be considered by sponsors in the design of CTs as alleviating this burden on patients may help overall recruitment. Limitations of this study include its retrospective nature, manual data extraction, and consistency of research team documentation. The results suggest that introducing support groups and interventions to provide transportation services for trial patients may be beneficial to enrollment and retention.

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