Navigation’s Impact on Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

August 2019 Vol 10, No 8

Categories:

Clinical Trials
Claire White, BSN, RN, CPHON
The Children's Hospital of Philadelphia, Philadelphia, PA
Laura Hynes, MA, BSN, RN
Brain Tumor Network
Ponte Vedra Beach, FL
Lucy J. Gansauer, MSN, RN, OCN, CCRP
Director of Cancer Care Delivery Research, Spartanburg Medical Center; AONN+ Clinical Trials Committee Co-Chair
Mary Van Cleave, BSN, RN, OCN
Mills Breast Cancer Institute, Carle Cancer Center
Urbana, IL
Lavinia Dobrea, RN, MS, OCN
The Center for Cancer Prevention and Treatment
St Joseph Hospital
Orange, CA
Amy Meleason, BSN, RN, OCN
Sarah Cannon at HCA Virginia
Richmond
Daniel McGough, BS, CCRP
Texas Oncology Research
Clinical trials play a critical role in advancing cancer prevention and care. Cancer clinical trials produce evidence that supports treatment advancement with the ultimate goal of reducing morbidity and increasing survival in oncology care. They help us find ways to improve the quality of life of our patients and help us understand how we can prevent cancer.

If you ask a packed auditorium, Who has climbed Mount Everest? you may get a smattering of hands raised. If you ask that same room, Who has ever participated in a clinical trial? it’s likely you will get a similar response. Much like climbing Mount Everest, the clinical trial arena is extensive and daunting; therefore, one needs a good understanding of the process and the barriers to participation.

A prospective evaluation of cancer clinical trial accrual patterns identified that the most common reasons patients did not enroll were related to a desire for other treatment, distance from the cancer center, and insurance denial. Interestingly, patients with private insurance were less likely to enroll in clinical trials compared with those with government-funded insurance.1,2

Recruiting eligible participants remains one of the most challenging pieces in completing clinical trial studies. As of May 23, 2019, ClinicalTrials.gov had a total of 306,651 registered studies; 34% or 105,465 are listed within the United States. As of September 2018, ClinicalTrials.gov receives an average of more than 219 million pageviews per month and 116,000 unique visitors daily.3 Despite the large number of clinical trials available and the obvious interest as indicated by the number of daily views recorded by ClinicalTrials.gov, recruitment numbers remain low. Unfortunately, many barriers remain to the clinical trial accrual process. Speaking with nurse navigators at the Brain Tumor Network, an organization that assists patients in vetting clinical trial matches, there are several thematic barriers found in their experience.3,4

Trial design can be a barrier. Patients are often unwilling to participate in a phase 1 study, and phase 3 studies are not as abundant.3,4 Frequently, patients do not want to put the time and effort into a trial if they are going to be blindly randomized to the control arm. Also, trials can have very narrow eligibility requirements to produce a treatment effect that is consistent across the cohort, which is a barrier unto itself.

Timing can be problematic when attempting to accrue to clinical trials. Patients are typically not learning about clinical trials until they have failed initial standard-of-care therapy.3,4 They may have missed an eligibility window to enter a trial. There is a general paucity of insight on when the right time is to enroll in a clinical trial.

There is also a lack of knowledge of the clinical trial structure or intent. Some patients fear the unknown; they have no frame of reference for the clinical trial. Some patients are hesitant to ask more questions of their referring physician, thinking they are questioning his/her expertise in their recommendations. Many participants worry about getting a placebo despite attempts to educate to that point. Finally, some patients simply fear potential experimental therapy toxicities. Often patients are hesitant to deviate from the “known” treatment of current standard of care, which they may already be receiving. Specific genetic/biomarker testing may not have been done to validate eligibility, and often there is not time to wait for those results before initiating treatment for an aggressive form of cancer. Occasionally patients are told to find trials on their own when in the office setting. In many facilities there simply is not enough time or manpower for a provider or their staff to do the searching for their patients.5

Anna Roberts, RN, BSN, OCN, New Patient Program Team Lead at The Preston Robert Tisch Brain Tumor Center at Duke Cancer Institute, stated, “I believe the biggest barrier to enrollment in clinical trials is unawareness. Most often I see that patients miss the window of time for eligibility, or start a new treatment not realizing that it excludes them from trials at this time. If patients and their families were educated about seeking clinical trials promptly upon diagnosis, more trials may be available to them over the disease process.”6

One breast cancer survivor who did participate in a clinical trial offered feedback on her own experience regarding the education barrier to clinical trials. “I did not go in search of many trials. I started to, but what I did look at was hard to figure out what I was a good candidate for and what I was not. The explanations were long and a lot of terminology I did not know. Any time I read about any trial it just made my head hurt, and I put it back down and did not pursue it. I participated only in 2 that my doctor approached me about. Every step of the way with cancer, with the genetic testing, treatment, trials—I always felt like there was a lot of posturing. Very little transparency. Never a straight answer, either because there was not a clear answer, or because they try to only tell you things in the most positive light. I get it—I believe that hope has a placebo effect that actually helps healing. But I always felt like I wasn’t getting a full story. Same with trials, when you ask for details on how they think its going, why they think it will work, etc. The people administering it have no idea. The research nurses were great, but they were overseeing many patients in many different trials and did not always know a lot about side effects of the med I was on, or have any idea if it seemed to be working” (L. Dobrea, oral communication).

One in 4 patients are concerned about how to pay for trial participation despite legal regulations requiring most insurers to cover routine care associated with a clinical trial. Coupled with this concern, patients may also struggle to determine their ability to pay for costs that are associated with treatment during a clinical trial. Clinical trial participation may mean traveling farther for visits or an increase in visits to the facility. There may be additional costs for transportation, lodging, and meals while away from home. There is also the burgeoning financial stress of the time away from work and the cost of childcare. Some clinical trials have funding to support travel for extended treatment periods.

The Patient Protection and Affordable Care Act does provide a few protections for patients that help to ensure equal and timely access to treatment on qualifying clinical trials. To qualify for this coverage, a few general requirements must be met. The patient must be an appropriate candidate for the trial, and the patient’s care provider or the patient themselves must provide evidence that the patient’s participation is appropriate. The trial must meet the general requirements set forth by the Centers for Medicare & Medicaid Services. A phase 1, 2, 3, or 4 trial meets the definition of an “approved” clinical trial if it is conducted for the prevention, detection, or treatment of cancer. It must also be federally funded, or conducted under an investigational new drug application reviewed by the FDA. If all these requirements are met, routine patient care, which includes services that a payer would normally cover for a patient with a similar diagnosis not enrolled in a clinical trial, must be covered benefits. This requirement applies to most third-party payers of health benefit or insurance claims. Knowledge of these protections is important for navigators who are caring for patients who wish to seek clinical trial access.7

The cost of cancer care is rising quickly in the United States, and the value associated with the rising cost is unclear. Hirsch and colleagues note that there are likely multiple factors associated with this problem, including a lack of comparative effectiveness research, inefficiencies in trial execution, increasing use of off-label agents, and an increasing reliance on less robust trial designs.8

Despite these resources, patients and their caregivers may find it difficult to cover costs. Navigators are positioned to partner with nonprofit organizations that can provide resources to patients and their caregivers. Access to these resources may help to eliminate or reduce a patient’s financial barrier to clinical trial enrollment.

Whereas 88% of the public exhibit good understandings of the value of clinical research, only 5% of adults participate in clinical trials; 60% of children younger than 15 years participate in clinical trials.5 There is a large gap between those who report to be very willing to participate in a clinical trial (59%) and those who are somewhat willing (33%). Partnering with the patient’s care team, the navigator can provide education, care coordination, and support that may move a patient along the road to engage in clinical trial enrollment.9

Navigators specialize in care coordination. Their role with clinical trials is to help patients get access to high-quality cancer care, including clinical trials. This is especially true in rural areas, and for minorities, the underserved, or elders. Navigators are in an ideal position to promote and facilitate a discussion of cancer clinical trials with their patients. Their expertise can aid in the access to treatment by an assessment of trial availability as well as to determine the narrow eligibility criteria and comorbid conditions.

Navigators are able to provide education to patients to help alleviate the lack of knowledge they may have about clinical trial participation. A patient who believes that the best possible treatment option is to be found in a clinical trial is more likely to participate in that clinical trial; patients are generally driven by seeking the best possible treatment option. There may be fear surrounding clinical trials, which could be related to randomization, or fear of potential toxicities from experimental therapy. Navigators can be instrumental in alleviating these fears. Navigation can impact the time spent attending to the details of clinical trial enrollment and providing patient explanation.

For cancer clinical trial enrollment to occur, multiple factors must be in place. These include access to treatment, assessment of trial availability, assessment of patient eligibility for available trials, discussion of trial participation, and, ultimately, if all of these steps occur, the patient must choose to enroll. Navigators are in an ideal position to promote and facilitate a discussion of cancer clinical trials with their patients and support their ability to participate.

References

  1. Lara PN Jr, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19:1728-1733.
  2. Unger JM, Cook E, Tai E, Bleyer A. Role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;5:85-198.
  3. ClinicalTrials.gov. Trends, Charts, and Maps. https://clinicaltrials.gov/ct2/resources/trends.
  4. National Cancer Institute. What Are Clinical Trials? www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials.
  5. American Cancer Society. The Basics of Clinical Trials. www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/clinical-trial-basics.html#references.
  6. Hynes L. Anna Roberts, New Patient Program Team Lead. The Preston Robert Tisch Brain Tumor Center at Duke. May 16, 2019.
  7. American Society of Clinical Oncology. Summary the Affordable Care Act Statute Regarding Insurance Coverage for Individuals Participating in Approved Clinical Trials. www.asco.org/sites/new-www.asco.org/files/content-files/research-and-progress/documents/affordable-care-act-summary-clinical-trials.pdf.
  8. Hirsch BR, Califf RM, Cheng KM, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med. 2013;173:972-979.
  9. Center for Information and Study on Clinical Research Participation. Report on General Perceptions and Knowledge on Clinical Research. www.ciscrp.org/wp-content/uploads/2019/06/2017-CISCRP-Perceptions-and-Insights-Study-Perceptions-and-Knowledge.pdf.
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Last modified: August 6, 2019

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