Minimizing the time between a tissue diagnosis of cancer and patient identification, recruitment and enrollment in clinical trials.
Objective: Increase patient enrollment in cancer clinical trials.
Research question: Does the early identification of patients who are eligible for clinical trials, combined with patient education and recruitment by a patient navigator, increase rates of enrollment in clinical trials?
- The clinical pathology laboratory transmits a copy of the pathology report describing the patient’s cancer diagnosis to Recentia Health, contemporaneous with transmission of the pathology report to the referring physician.
- Recentia’s staff enters the pathology report into Recentia’s tumor registry, an electronic medical records system that supports semantic interoperability with the National Library of Medicine’s Unified Medical Language System (UMLS) and the National Cancer Institute’s NCI Thesaurus.
- Recentia’s tumor registry assigns an NCI Thesaurus code to the patient’s stage-specific cancer diagnosis, e.g., NCI Code C9102is assigned to Non Small Cell Lung Cancer Stage IIIA.
- Recentia’s tumor registry assigns a UMLS Concept Unique Identifier (CUI) to each clinical term in the pathology report, e.g., UMLS CUI C1960925 is assigned to Epidermal growth factor receptor positive non-small cell lung cancer.
- Recentia’s clinical decision support system compares the patient’s diagnosis, NCI Code, clinical profile and demographic information to a list of active clinical trials.
- If the patient is matched to an active clinical trial, Recentia’s patient navigator contacts the patient’s physician for permission to contact and educate the patient about the clinical trial(s) the patient may be eligible for enrollment in.
- With the physician’s permission, the patient navigator contacts and educates the patient about the benefits of enrolling in the clinical trial.
- With the patient’s permission, the patient navigator assists the patient with enrollment in the clinical trial.
Evaluation: Because this is a proof of concept, we are evaluating the resources and institutional agreements required to implement the proposed intervention.