Background: Only 2% to 3% of adult cancer patients enroll in clinical trials (CTs). Multiple barriers are reported in the literature as reasons why patients do not participate in cancer drug development trials. One key factor is the lack of patient awareness and knowledge of the availability of treatment options through CTs. Participation in a CT is a frequently missed opportunity for patients to access new therapies that may not be suggested by the primary oncology team. In addition to the potential benefits for patients who participate in drug-development CTs, the significant contributions of CTs serve to advance the science and effectiveness of new cancer treatments. Patients may believe that CTs are only for end of life or have misconceptions about placebo-based studies and therefore choose not to pursue CTs.
Objectives: Define the unique responsibilities and profound impact of the Advanced Practice Nurse Navigator (APNN) in phase 1 CTs.
Methods: The APNN role is unique and vital in educating patients and the public regarding the availability of CT options and potential benefits. The APNN utilizes advanced assessment skills for early problem identification and intervention. Upon inquiry from patients and/or their family, basic information such as diagnosis, current treatment, and performance status are determined. Based on initial intake, additional discussion/education takes place regarding several issues, including optimal timing for consultation to discuss if and when CTs may be a treatment option; symptom management; nutritional status; and talking points to discuss with the primary oncologist. Evidence-based resources, ie, NCCN guidelines, are provided to patients. When consulted, the APNN provides follow-up and ongoing contact and intervention for patients throughout their cancer journey from diagnosis to recovery.
Results: At our institution, between the years 2007 and 2011, the APNN role contributed to the tripling of consultations (from 22% to 73% of all referred patients). Participation in CTs may enhance quality and quantity of life for enrolled patients. Patients are provided with evidence-based guidelines that outline both standard of care and CTs. The APNN guides and empowers patients through the maze of complexities in identifying appropriate CTs, availability, eligibility, and site location. Many patients who have exhausted standard-of-care options find hope in the new opportunities provided by CTs.
Conclusions: The APNN plays a crucial role in phase 1 CTs by providing patients with accurate information and guidance. Navigating through study selection and enrollment is a tedious task that can be simplified by the services of the APNN. The APNN navigates patients through the multiple barriers that limit CT participation. This role has the potential to profoundly increase patient participation in CTs. Research is desperately needed to measure patient outcomes related to APNN intervention, including accrual to CTs and patient satisfaction.