A Cross-Sectional Study of Patient Perspectives on Clinical Trial Participation in a Large Community-Based Research Facility

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ABSTRACT

We investigated patient perceptions of cancer clinical trials and the consent process through a 13-year cross-sectional study involving 340 individuals currently enrolled in or having recently completed a cancer clinical trial. We employed a structured, face-to-face questionnaire comprising 27 multiple-choice and yes/no questions.

This study elucidates patient experiences in clinical trials (questions 1-16) and their perspectives on the consent process (questions 17-27). Results of this study emphasize the positive impact of community-based oncology methods on clinical trial patients, and the need for revised consent methods that alleviate patient confusion and apprehension.

INTRODUCTION

In the United States, fewer than 5% of adult cancer patients opt to participate in cancer clinical trials, despite 70% of US adults expressing a willingness to engage in such trials.¹ Advances in cancer treatment are largely dependent on clinical trials to evaluate the safety and efficacy of new treatment options.

In order to execute clinical research, sufficient patient enrollment is crucial, and therefore, so is understanding what is discouraging patients from enrolling and what hesitations and feelings they experience through all stages of a trial, including the consent process.

Many patients with cancer experience intense fear related to their diagnosis and corresponding treatment, especially for those lacking strong support systems.² This fear is a leading cause of low patient enrollment in cancer clinical trials; however, this can be combated with sufficient trust in medical professionals and comfort in a clinical setting.³ Other causes of low enrollment include the lack of a staff dedicated to enrolling, specific protocol issues and inclusion criteria, financial reasons, and access to care.⁴

Community oncology or privately owned oncology clinics unassociated with larger academic hospitals or institutions prioritize local, affordable care that lessens the burden of cancer by keeping patients close to their support networks.⁵ The expense of the same cancer treatment can be up to 50% lower in a community setting than in a hospital setting, translating to patient monthly savings of nearly $25,000.^6,7

Notably, 85% of US adult cancer patients are treated in community settings, with over 900,000 patients treated each year, a testament to the accessibility and impact of community oncology.^8,9 Patients in these community settings also experience more prompt initiation of treatment after diagnosis and are less likely to necessitate emergency department visits post-treatment.⁹

Despite their ease and affordability on the patient’s end, community oncology clinics are dwindling rapidly. Due to the increasing cost of drugs and cancer treatment, and the high cost of staffing a unit, financial burdens are causing a mass migration from physician-owned to hospital-owned treatment facilities, ultimately leading to higher copays. Since 2005, over 400 practices have been integrated into hospitals, and nearly half of all oncology practices are now owned by hospitals.¹⁰

Moreover, a significant number of existing community centers are refraining from engaging in clinical research, citing barriers such as inadequate reimbursements, insufficient resources and support, and the paperwork burden imposed on physicians and research staff.¹¹ The cost for community based clinical trial units is substantial, but that's where the patients are.^8,9

Established in 1999 by Dr. Nashat Gabrail, the Gabrail Cancer and Research Center (GCRC) is a large community-based oncology treatment and research facility in Canton, Ohio. GCRC cancer clinical trials span a diverse range of both solid tumors and hematological malignancies, with 10% of trials being first in human, 60% Phase I, and the remainder Phases II and III. Half of the enrolled patients are drawn from the center's patient database, while the other half are self-referred, often through word of mouth or clinicaltrials.gov.

Recognizing the significance of clinical trials, 90% of GCRC patients choose this treatment option, with more than 40% engaging in two or more trials sequentially, all while maintaining a minimal 3% dropout rate. Contrastingly, only 3% of US adult cancer patients choose clinical trials over other treatment options, and only 13% of oncologists practice as clinical investigators.¹¹ Understanding this contrast between GCRC and national averages is a key aspect of this study, and improving the success of others.

Furthermore, the informed consent process required of clinical trials is a lengthy one, and has been shown to negatively influence patient participation in clinical research.¹¹ GCRC, alongside other community oncology institutes, have questioned this process and whether its length and complexity impacts their own patients, and whether this process could be amended. In order to assess patient experiences from consent through treatment, GCRC designed a study with the following goals:

• Identify the factors that contribute to patients' willingness or reluctance to participate in clinical trials.
• Understand the factors contributing to large community oncology clinic enrollment and retention rates.
• Assess patients' overall satisfaction, perceptions, experiences, and motivations.
• Assess patients' experiences with the consent form in order to guide improvements in form length, readability, and comprehension.
• Provide evidence-based data that can be used to guide clinical practice and decision-making in a way that maximizes patient well-being and trial success.

METHODS

This research aimed to comprehensively investigate patient perceptions of cancer clinical trials and the associated informed consent process through a face-to-face, one-on-one survey methodology. The study spanned a 13-year period from 2010 to 2023, encompassing a cohort of 340 patients (n=340) currently enrolled in or having recently completed a clinical trial (<5 years). The survey comprised 27 questions, structured as 16 items detailing the patient's experience within the clinical trial and 11 items exploring their perception of the consent process.

All interviews were conducted in a private and comfortable environment during the patients' routine appointments, and responses written down by the interviewer. Interviewers were undergraduate and medical students unaffiliated with the participants' treatment, in an effort to minimize bias.

Participants were explicitly informed about the anonymity of their responses and were encouraged to respond candidly. Verbal consent was obtained from all patients prior to participation and they were informed of their right to decline any question. The survey protocol ensured uniformity and consistency across all participants.

RESULTS

Demographics

Out of the 340 participants, 93% identified as white, 4.5% as African American, and 2.5% as Hispanic, Asian, Middle Eastern, or Native American, aligning with the demographic composition of Stark County, Ohio, where the GCRC is situated.¹² The gender distribution was nearly equal, with 51% female and 49% male participants, with an average age of 66 years. Predominant malignancies included multiple myeloma (13%), non-small cell lung carcinoma (10%), prostate (8%), ovarian (6%), and breast (6%) (Figure 1).

Figure 1. Chart displaying participant malignancies.

Patient Experience

The first half of the survey aimed to better understand the histories of cancer clinical trial participants as well as barriers and emotions throughout the process. Forty percent of patients had participated in more than one clinical trial at the time of their interview, and 87.6% learned about their trial through GCRC or Dr. Gabrail (Figure 2).

Figure 2. Question 2: Where did you first find out about the clinical trials offered here?

In terms of trial length, indifference was reported by 73.8%, while 16.5% found their trial(s) excessively long, often due to severe adverse effects (AEs) (Figure 3). Travel convenience to GCRC was reported by 79.7% of participants.

Figure 3. Question 3: What did you think of the length of your clinical trial?

Of those needing transportation assistance (46.8%), travel influenced the decision to enroll for 50.9%. Patient comfort at GCRC received high ratings, with 91.5% indicating thorough explanation of medical procedures, 99.7% finding the staff helpful, and 91.8% acknowledging adequate updates throughout the trial, good or bad.

The primary motivations for enrollment included personal benefit (48.2%; Figure 4), with 93.5% having health insurance at the time.

Figure 4. Question 8: Why did you decide to enter a clinical trial?

Common fears pre-enrollment were the treatment's ineffectiveness (17.1%) and potential AEs (23.2%); however, 44.1% reported no fears or hesitations (Figure 5).

Figure 5. Question 11: When thinking about entering the trial, what were your initial reservations/hesitations?

Post-trial fears included treatment failure (19.4%), long-term AEs (14.7%), and cancer recurrence (12.6%). But, once again, the most common response was “None” (44.7%; Figure 6).

Figure 6. Question 12: What was/is your biggest fear post clinical trial?

A notable 95.6% expressed willingness to recommend participation in clinical research at GCRC, which decreased to 67.4% when considering participation elsewhere. Overall, 75% viewed their trial experience positively, while 18.8% deemed it fair.

Consent Process

In the assessment of the consent process, 59.1% spent less than an hour reviewing the form (Figure 7), 55.9% did not read the entire document, and 41.2% claimed it was too long (Figure 8).

Figure 7. Question 17: How long did it take to read the consent form?

The majority (97.4%) felt they had sufficient time to make an informed decision, often facilitated by the flexibility to review the form at home.

Figure 8. Question 22: What do you think of the length of the consent form?

While 29.7% struggled with parts of the form, 84.7% found GCRC staff assistance helpful in comprehending it. A subset (25.6%) of patients were unsure of the number of forms they were asked to sign during their consent process, and 40.7% lacked understanding of the purpose of additional forms.

Sixty-five percent of participants never revisited the form post-signing; however, of those who did, 94.9% found it helpful. Importantly, 79.4% believed the form adequately explained experienced AEs, and 90.9% understood the option to withdraw from the trial at any time.

DISCUSSION

The declining number of community oncology clinics, as well as the increasing barriers preventing existing clinics from participating in clinical research, is an increasingly pressing issue. Given that 85% of patients with cancer are treated in community settings, finding ways to prevent community centers from folding into hospitals, and encouraging practices to be more involved in research, is essential to treating patients close to their support systems, and providing high quality care.¹³

Enrollment and retention rates at GCRC surpass national averages, and while acknowledging the potential bias in selecting participants from the clinic population, we attribute these favorable rates to several factors.¹⁴ GCRC’s principal investigator, Dr. Gabrail, directly engages in discussing consent himself, rather than relying on surrogates, the research staff is adept at alleviating any patient concerns, and they ensure sufficient outreach from contract research organizations (CROs) and pharmaceutical companies to secure trial placements. Additionally, the substantial patient population helps offset the high overhead costs associated with running a research unit.

Our research was conducted through direct, face-to-face interactions with patients, distinguishing it from other studies often conducted via questionnaires or telephone calls.^13,15-17 This approach facilitated genuine engagement, provided opportunities to address any confusion, and allowed for the observation of non-verbal cues. Our study, in contrast to similar research, demonstrates a more comprehensive understanding of AEs (79% vs. 42%) and a clearer grasp of the option to unenroll at any time (91% vs. 70%).¹⁶

However, comparable percentages were observed for overall comprehension of the form, overall satisfaction, and the shared patient goal of seeking treatment for personal benefit, as well as to contribute to future research.^17-20 Notably, a substantial 95.6% of participants expressed a willingness to recommend participation at the GCRC, underscoring the positive impact of community-based oncology on patient engagement and satisfaction. However, this endorsement declined significantly to 67.4% when contemplating participation elsewhere, emphasizing the unique value and trust patients place in the community setting.

Our findings reveal that a significant proportion of participants (87.6%) learned about clinical trials through GCRC, emphasizing the pivotal role of community-based oncology in patient engagement. The high rates of positive responses regarding patient comfort, achieved through thorough explanations of medical procedures (91.5%), and helpful staff interactions (99.7%), emphasize the significance of the supportive environment provided by GCRC.

Our study aligns with others in that patients are more likely to enroll when medical professionals make them feel like a partner in the process.²⁰ Travel distance is a recognized obstacle in attaining cancer treatment;²¹ however, 79.7% of participants found travel to GCRC convenient, which influenced 49.1% of them in their decision to enroll.

Despite the positive aspects, our study identifies crucial areas for improvement. A substantial percentage (55.9%) did not read the entire consent form due to its length, indicating a potential barrier to fully informed decision-making.

Although 97.4% felt they had sufficient time to decide, 29.7% admitted to struggling with parts of the form. However, 84.7% found GCRC staff helpful in overcoming these struggles, possibly attributable to the direct and intimate interaction provided by the principal investigator during the consent process. These findings highlight the necessity for revising consent forms to enhance readability and comprehension, as well as the role community oncology plays in easing the burden of informed consent.

This study stresses the pivotal role of community oncology clinics in cancer care and clinical research, emphasizing the imperative for their refinement to elevate patient experiences and uphold the integrity of clinical research nationwide. Community oncology clinics serve as vital centers for delivering localized and accessible cancer care, yet this paper illuminates areas necessitating improvement to fully utilize these settings.

By addressing identified deficiencies, such as streamlining administrative processes, addressing the consent process, and enhancing patient support services, more clinics can cultivate positive patient experiences and preserve the overall success of clinical research in the United States.

PRESENTATION

Results of this study were presented at the Sargon Research Summit held on August 18-19, 2023, at the Pro Football Hall of Fame in Canton, Ohio.

ACKNOWLEDGMENTS

We express our sincere gratitude to the survey participants, Gabrail Cancer & Research Center Staff, Thomas Abberton, Dr. Jamie Oliver, and the students that helped conduct surveys over the past 13 years – K. Akrom, R. Rosia, B. Kasturiarachi, L. Zerner, J. Rigg, K. Bricker, and K. Semon.

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