top of page
  • Writer's pictureLighthouse

The Benefit of Patient Navigators in Cancer Clinical Trials

Summary in Thirty Seconds

  • Patient Navigators (PNs) began as educators to assist underserved people with cancer in overcoming barriers to timely care; however, PN roles have greatly expanded in scope and now include assisting cancer patients to enroll in cancer clinical trials (CCTs).

  • Research on the impact of PNs on CCTs reveals that using a PN can at least double historically low CCT accrual rates.

  • Poor diversity in CCTs is a well-known problem, and using PNs has been found to significantly improve the representation and retention of ethnic minorities in CCTs through improved communication and trust, access to financial help, and reductions in regret.

  • To be most effective, PNs must be good communicators, respectful of all cultures and persons, understand their professional role and boundaries, be detail-oriented and organized, compassionate, and have good follow-through.

  • Using PNs for CCT enrollment is more patient-centered and increases awareness, knowledge, and access to appropriately matched clinical trials, facilitates access to community resources, and improves communication between the patient and treatment team.

Patient Navigators

Taking a first-time trip to a foreign country often goes more smoothly if the visitor has a guide or host to show her around. The guide can interpret the foreign language (including important idioms and local terms), shepherd the visitor around financial traps and common pitfalls, and help answer questions to increase understanding and reduce misinterpretations. Similarly, most people with cancer do not enter the cancer landscape with a great deal of “local knowledge.” They don’t know the medical vocabulary, genetic terminology, or pharmaceutical jargon. They are unfamiliar with the terrain of medical specialists, cancer treatment, and clinical trials. And they may come into oncology with fears, mistaken beliefs, and incorrect assumptions. So having an advisor to guide people with cancer in this “foreign land” helps make the cancer journey run much better by answering questions, avoiding common dangers, providing help in finding treatment and trials, and allaying fears. This is the role of Patient Navigators (PNs).

The nation's first PN program for cancer was initiated in 1990 at a public hospital in Harlem, New York where the breast cancer death rate was extremely high in a population of poor Black women, half of whom presented in late stages of the disease. This program sought to eliminate barriers to timely care between the point of a suspicious finding and obtaining a diagnosis and treatment.[1]

Expanded Role of Patient Navigators

Over time, the role of PNs expanded from the focused scope first established to one that includes roles involving prevention, detection, diagnosis, treatment, survivorship, and research (including clinical trial enrollment).[2],[3] While 2-8%[4] of cancer patients enroll in CCTs, far more express willingness to do so.[5] Thus, many interventions have been suggested to improve CCT enrollment. One common suggestion is to utilize PNs, not only to improve CCT enrollment but also to enhance retention,[6] given that 20%-50% of patients drop out of CCTs.[7],[8]

Research Findings the Impact of PNs on CCT Enrollment

In a pilot study of 40 people with lung and esophageal cancer, 85% of patients consented to work with a PN. Among these patients, CCT understanding improved between pre- and post-testing, and 95% of patients working with a PN consented to participate in a CCT.[9]

A Clinical Trial Support Center (CTSC) formed by the Leukemia and Lymphoma Society in 2016 utilizes telephone-based PNs who assist cancer patients and their healthcare providers to identify all appropriate trials based on clinical data and patient preference, as well as facilitating informed and shared decision-making, and minimizing enrollment barriers. This organization studied 750 trial-eligible patients with leukemia or lymphoma and found that of the 537 (patient or caregiver/family member) who searched for a CCT on their own, 22.5% (121) enrolled in a trial with help from the CTSC PNs. Among the total of 750 eligible study patients, 16.1% enrolled in a trial with help from the CTSC PNs.[10]

The Clinical Trials Navigators (CTN) program was established in Canada to help patients in smaller communities navigate and enroll in CCTs. In a 2023 study, 25.5% of patients referred to a CCT enrolled in the recommended trial, and of all the patients studied, 8.5% of patients enrolled in a CCT,[11] which is about double the historical rate.[12]

A study of the “Improving Patient Access to Clinical Trials” (IMPACT) model assessed the effect of combining PNs and financial reimbursement on CCT enrollment. During the study period, 3,470 people with cancer enrolled in CCTs with greater enrollment numbers than would have been historically and statistically predicted. This study found that a financial reimbursement service combined with PN significantly accelerated enrollment to CCTs across tumor types, with a larger effect for late-phase clinical trials. Additionally, the interventions in this study also reduced issues with poor diversity often found in CCT enrollment.[13]

Patient Navigators and Ethnic Minorities

Ethnic minorities are underrepresented in CCTs, and the use of PNs has been proposed to improve enrollment. Selected studies evaluating the impact of PNs on CCT enrollment for ethnic minorities has found the following.

A total of 132 Black patients with breast cancer were screened by an oncology nurse navigator for eligibility for CCTs. 45% of patients were eligible for CCTs, and each was invited to participate in one or more CCTs for which they were eligible. 86% of eligible patients (39% of the 132 total screened patients) were enrolled in one or more research protocols. This study also found that the use of a PN to enroll these patients cost nearly half the cost of traditional methods of enrolling patients in CTs at cancer centers.[14]

In another study, 424 Black patients with cancer were referred to a project whose goal was to increase CCT enrollment diversity and CCT retention. 378 patients were eligible for a clinical trial, 304 (80%) enrolled in a trial, and 272 (72%) of those enrolled consented to receive ongoing patient navigation support. Overall, the participation of Black patients with cancer in CCTs increased from 9% to 16%. Of those receiving PN support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support.[15]

The University of Pennsylvania used a multi-modal approach to improving the enrollment of ethnic minorities into CCTs. This approach includes culturally tailored marketing; partnerships with faith-based organizations; transportation assistance; use of PNs to educate patients about CCTs. Prior to this intervention, 11% of CCT participants were Black, drawn from a population of people with cancer that is 16% Black. Post-intervention, the percentage had risen to 16.2%, and total CCT enrollment numbers rose by 41.5%.[16]

Another study evaluated 332 Native American cancer patients who received PN services throughout cancer treatment. The CCT accrual rate for the Native Americans in this study increased from a historical rate of less than 2% of people with cancer to 10% using PNs.[17]

The use of a PN to improve enrollment of ethnic minorities (and it can be argued these reasons apply to all prospective enrollees) to enhance CCT enrollment has been proposed as effective for the following reasons:

As noted, research shows that PN programs not only increase patient enrollment in CCTs, but several programs have also shown increased trial retention rates among underrepresented populations.[19]

Patient Navigators and Cancer Clinical Trials

Some suggest that simple patient-to-trial matching services are an effective means to increase CCT enrollment. However, such matching services can present barriers, including[20] the need of patients or their caregivers/family to understand:

  • the medical terminology regarding their diagnosis and treatment;

  • the CCT research process; specific trial exclusion/inclusion attributes to determine their interest and eligibility;

  • how to sort or refine search results.

Using PNs for CCT enrollment is more patient-centered and surpasses trial matching. While some academic research centers have created internal navigation services focused on trials within their institution, PN services now extend beyond that institution.[21] PNs focus on increasing awareness, knowledge, and access to appropriately matched clinical trials, facilitating access to community resources such as connection to a care coordination nurse or social worker within the health care system, and improving communication between the patient and treatment team.[22]

Effective Patient Navigation Characteristics

Research and experience have found that to be most effective, PNs must be good communicators, respectful of all cultures and persons,[23] understand their professional role and boundaries, be detail-oriented and organized,[24] compassionate, and have good follow-through.[25]

The Bottom Line

At the 2023 ASCO Annual Meeting, the Colorectal Cancer (CRC) Alliance Clinical Trial Think Tank proposed solutions to improve participation rates in CRC CCTs. Their three main strategic solutions were: 1) use marketing and messaging to improve trust in CCTs; 2) foster readiness for community-based cancer research; 3) employ CCT Patient Navigation.[26]

An ASCO review of the role of PNs concluded with four important points:

  • People with cancer benefit from the support of a PN.

  • Utilizing a PN can improve clinical trial enrollment, participant knowledge about CCTs, and trial retention.

  • Adequately trained PNs have the potential to increase not only overall CCT enrollment but also the accrual of racial and ethnic minorities.

  • It is feasible and cost-effective to integrate a PN into the CCT accrual process. [27]

These four points are supported by the research findings reviewed above. For people who work in the medical field, oncological pharmaceutical development, or related fields, the territory and terminology of oncology clinical trials may be at least somewhat familiar. However, all others with cancer can clearly benefit from having a guide who can help them navigate the unfamiliar cancer clinical trial journey.

[1] Canc. Epidem., Biomarkers, & Prev. 2012; 21(10):1614-1617 [2] Cancer. 2011;117(150):3539-3542 [3] Cancer. 2014; 120(S7):1122-1130 [4] J Natl Cancer Inst. 2021; 113(3):244- 257 [5] J. Clin. Oncol. 2003; 21:830-835 [6] ASCO Educ. Book. 2019: 39:105-114 [7] Brit. Med. J. 2013; 346:e8668 [8] BMC Med. Research Term. 2021; 21:7 [9] Cont. Clin. Trials Comm. 2016; 3:86-93 [10] J Oncol. Pract. 2021; 17(12):e1866-e1878 [11] J Clin Oncol. 2023; 41(16_suppl):e6521 [12] J Clin. Oncol. 2023; 41(16_suppl):e18661 [13] J of Cancer Policy. 2021; 30:100305 [14] Am J of Surgery. 2012; 203(4):415-422 [15] J Oncol. Pract. 2016; 12(6):556-563 [16] J Clin Oncol. 2021; 39(15_Suppl):100 [17] Front. Oncol. 2011; 1:00011 [18] Cont. Clin. Trials Comm. 2018; 12:98-102 [19] JCO Oncol. Pract. 2021; 17(12):e1866-e1878 [20] [21] Oncology Issues. 2014; 29:45-53 [22] ibid [23] Cancer. 2011; 117(15_Suppl):3543-3552 [24] Patient Educ. Couns. 2018;101(2):285-294 [25] [26] J Clin. Oncol. 2023; 41(16_suppl):e15603 [27] ASCO Educ. Book. 2019: 39:105-114


bottom of page