The linkage between Patient Navigation & Clinical Trails

Clinical trials and other pre-approval therapy alternatives can greatly benefit from the support of patient navigators, who assist in enhancing health literacy and lowering obstacles to obtaining healthcare.

A number of studies have demonstrated that many people have difficulty comprehending health information, and this can have a detrimental influence on their health results (Jayasinghe et al., 2016; Alemayehu et al., 2020). An estimated 80 million Americans are health illiterate, according to the National Institutes of Health (Hickey et al., 2019). However, despite the fact that health literacy is receiving increasing attention from European health officials, there is still a lack of information concerning the state of health literacy in Europe. Only a limited number of research on the prevalence of low health literacy around the globe have thus far been able to provide data on EU population health literacy levels (Lorini et al., 2020).

Clinical trials are no exception to the rule when it comes to complicated health information (Varkey, 2021). There is a lot of jargon and intricate ideas involved in clinical trials, which are research studies designed to examine the safety and efficacy of pharmaceuticals in development on patients' well-being. To help patients with life-threatening or serious illnesses get access to medications currently in development outside of clinical trials, patient navigation initiatives are essential.

Most patients are unaware that clinical trials are a possibility, let alone how to locate clinical trials or be offered a clinical trial. Nearly a quarter of cancer patients do not engage in clinical trials, according to recent research. This is not because of eligibility requirements that limit which patients may enroll, but rather because of impediments connected to patients or physicians (Asher et al., 2022). But researchers have shown that patient navigation may play a key role in educating patients about clinical trials, as well as assisting with recruitment and retention.

The role of patient navigation is common in healthcare companies, where they help patients learn about their health and remove roadblocks to getting the treatment they need. Harold Freeman, a New York City-based doctor, originally defined and executed the Patient Navigator in medical literature in 1990 (Freeman, & Rodriguez, 2011). He began the initiative as a response to the alarmingly high mortality rates associated with late-stage breast cancer in this predominately black neighborhood. Using the navigation, Dr. Freeman aimed to raise awareness about breast health issues and remove roadblocks that prevented women from getting the treatment they needed.

Since then, in the United States, the usage of patient navigation in cancer screening and treatment has grown significantly. Clinical studies have lately begun to use navigators. They can help patients comprehend the process of clinical research and assist them in finding and enrolling in clinical trials. Clinical trial navigation is another name for these individuals. Supporting patients in this way contributes to bridging the gap between clinical treatment and research in the long run.

The American Society of Clinical Oncology estimates that just 5 percent of adult cancer patients in the US engage in clinical trials (ASCO). The opposite is true in the field of pediatric oncology, where ASCO reports that 75% of children with cancer who participate in clinical trials go on to have long and healthy lives. Adults with particular cancers may have a better chance of surviving if more of them participate in research trials, according to some doctors (Viale, 2017). Others have pondered if navigators could assist bring about this transformation, while others have expressed their concerns. Adult cancer patients should be able to speak with a trial navigator, who would address reasonable and irrational fears, present a tailored list of trials, and analyze their appropriateness. Patient support and advocacy organizations are a popular way for patients to interact online, and many patients utilize the Internet to research their ailments and look into treatment alternatives.

In order to assist patients (and their caregivers) learn about all of the treatment choices available and locating clinical trials, several HCP have developed a patient-friendly solution. This platform connects patients with unmet medical needs to medicines currently being developed across the world. Each patient is given a patient navigator. Besides helping people locate clinical trials, they also provide other services. A team of medical professionals trains and supervises each patient's navigation to ensure they are up to par. When it comes to technical medical language (e.g. molecular profiling, eligibility criteria, and clinical trial phases), the navigators take the time to explain it in a way that is more understandable.

Each stage of the search for treatment choices is walked patients through by the patient navigation. It is possible to search clinical trial databases across any close and open and collect information about all available treatment alternatives, offering answers to a patient's questions based on his or her medical record. The use of patient navigation has been found to be effective in increasing enrolment in clinical trials, despite the fact that total trial participation is still low. Patient enrollment rates in clinical trials can be as high as 95% following patient guidance, according to certain research. The term clinical trial navigation is used in several papers to describe these navigators (Fogel, 2018).

According to research conducted by Ryan et al., (2019) the vast variety of patient obstacles to clinical trial participation and navigator help revealed in this study supports the clinical trial navigator function in promoting excellent treatment. The impact of patient navigators on clinical trial participation is being evaluated for the first time in a randomized, controlled experiment at Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center (Uveges et al., 2018). The Increasing Minority Participation in Clinical Trials program received referrals from 424 African American cancer patients between 2007 and 2014. Whilst 304 (80.4 %) of individuals who were eligible for a clinical study (a total of 378) signed up for one, and 272 (72 %) agreed to have patient navigation help provided. 74.5 percent of individuals who received patient navigation help finished the experiment, compared to 37.5% of those who did not. There was a statistically significant difference in retention rates between the two groups (P .001). Participation in clinical trials for cancer treatments by African Americans grew from 9% to 16% (Fouad et al., 2016).

When compared to non-patient navigation studies, patient navigation in clinical trials was more effective in retaining African Americans' participation in therapeutic trials. In terms of reducing inequalities in cancer clinical trial participation, the concept shows potential. A racial/ethnic minority population should be studied in future research.

More than ever before, patients are more connected and empowered. In spite of this, a lack of knowledge remains a constant impediment. As a result, there is a pressing need for increased education and knowledge regarding clinical trials and how to identify and enroll in them. Studies published in medical journals have indicated that trial navigation can play a key role in improving enrolment and retention. Anecdotally, these findings are further supported by the successful usage of patient navigation to assist patients in discovering clinical trials and gaining access to them.

In addition to helping patients, patient navigation can provide pharmaceutical firms with a new way to recruit for studies that are critical to the development of new drugs. Patients and pharmaceutical firms alike depend on the rapidity with which new drugs are developed, and as the number of clinical trials grows, using patient navigators to speed up the recruiting process is a smart move.

References

Alemayehu, Y. H., Seylania, K., & Bahramnezhad, F. (2020). The relationship between health literacy and quality of life among hemodialysis patients: An integrative review.?Human antibodies,?28(1), 75–81. https://doi.org/10.3233/HAB-190394

Asher, N., Raphael, A., Wolf, I.?et al.?Oncologic patients’ misconceptions may impede enrollment into clinical trials: a cross-sectional study.?BMC Med Res Methodol?22,?5 (2022). https://doi.org/10.1186/s12874-021-01478-5

Fogel D. B. (2018). Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.?Contemporary clinical trials communications,?11, 156–164. https://doi.org/10.1016/j.conctc.2018.08.001

Fouad, M. N., Acemgil, A., Bae, S., Forero, A., Lisovicz, N., Martin, M. Y., Oates, G. R., Partridge, E. E., & Vickers, S. M. (2016). Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials.?Journal of oncology practice,?12(6), 556–563. https://doi.org/10.1200/JOP.2015.008946

Freeman, H. P., & Rodriguez, R. L. (2011). History and principles of patient navigation.?Cancer,?117(15 Suppl), 3539–3542. https://doi.org/10.1002/cncr.26262

Hickey, K. T., Masterson Creber, R. M., Reading, M., Sciacca, R. R., Riga, T. C., Frulla, A. P., & Casida, J. M. (2018). Low health literacy: Implications for managing cardiac patients in practice.?The Nurse practitioner,?43(8), 49–55. https://doi.org/10.1097/01.NPR.0000541468.54290.49

Jayasinghe, U. W., Harris, M. F., Parker, S. M., Litt, J., van Driel, M., Mazza, D., Del Mar, C., Lloyd, J., Smith, J., Zwar, N., Taylor, R., & Preventive Evidence into Practice (PEP) Partnership Group (2016). The impact of health literacy and lifestyle risk factors on health-related quality of life of Australian patients.?Health and quality of life outcomes,?14, 68. https://doi.org/10.1186/s12955-016-0471-1

Lorini?C,?Lastrucci?V,?Paolini?D?Florence Health Literacy Research Group, et alMeasuring health literacy combining performance-based and self-assessed measures: the roles of age, educational level and financial resources in predicting health literacy skills. A cross-sectional study conducted in Florence (Italy)BMJ Open?2020;10:e035987.?doi:?10.1136/bmjopen-2019-035987

Ryan D. Nipp,?Kessely Hong, and?Electra D. Paskett American Society of Clinical Oncology Educational Book?2019?:39,?105-114

Unger, J. M., Hershman, D. L., Till, C., Minasian, L. M., Osarogiagbon, R. U., Fleury, M. E., & Vaidya, R. (2021). "When Offered to Participate": A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials.?Journal of the National Cancer Institute,?113(3), 244–257. https://doi.org/10.1093/jnci/djaa155

Uveges, M. K., Lansey, D. G., Mbah, O., Gray, T., Sherden, L., & Wenzel, J. (2018). Patient navigation and clinical trial participation: A randomized controlled trial design.?Contemporary clinical trials communications,?12, 98–102. https://doi.org/10.1016/j.conctc.2018.09.003

Varkey B: Principles of Clinical Ethics and Their Application to Practice. Med Princ Pract 2021;30:17-28. doi: 10.1159/000509119

Viale P. H. (2017). The American Society of Clinical Oncology Reports on the State of Cancer Care in America: 2017.?Journal of the advanced practitioner in oncology,?8(5), 458–459.