Patient Navigation in Cancer Treatment Clinical Trials

Patient Navigation in Cancer Treatment Clinical Trials


We are pleased to invite cancer centers and community oncology practices already involving patient navigators in cancer treatment trials to participate in our 7-month pilot demonstration project. Three sites will be selected for participation – 2 in the U.S. and 1 in Canada. The goal of the pilot is to demonstrate the impact of patient navigation on increasing cancer clinical trial participation.

Thank you to our funder!

Program Overview
Site Qualifications for Participation


The role of patient navigators is currently underutilized but well-suited to provide coaching and decision-support services around clinical trials, helping patients weigh their unique concerns around receiving care through standard treatment or within a cancer trial. Using patient navigators in the research setting can be both cost-effective as well as efficient. Relieving burden from the clinical research staff can help them better support and track patients already on clinical trials. Ensuring strong linkages with general patient navigation services can also ensure strong continuity of care. 


This Pilot will demonstrate the impact of “patient activation” within 3 patient navigation programs currently operating in the cancer clinical trials setting. Over a 7 month period, ENACCT will assess the impact of this model on:

  • Increased screening of all newly diagnosed cancer patients for clinical trial eligibility
  • Increased discussions about clinical trials with newly diagnosed eligible patients and their treating physicians and other clinical staff
  • Accrual of newly diagnosed patients onto clinical trials

Program Overview

This program will utilize the novel approach of specific support around clinical trial decision making to encourage patient action and dialogue with their physician and the research team. This method has been utilized successfully in projects across the country, leading to increased clinical trial participation. For example:

  • Patient activation through the use of “pre planning visits” to assist patients in determining what they hope to get out of an upcoming physician visit and what questions they need answered
  • Decision support utilizing question listing to improve coping and decision making skills, enhance patient dialogue about clinical trials

Through its extensive research on these and other models, ENACCT has developed a comprehensive new model for patient activation in the clinical research setting, utilizing patient navigators. ENACCT staff will work collaboratively with an expert committee and each of the selected sites to tailor this new model for optimal and successful implementation.

A more in-depth program overview is provided within the application materials below

Site Qualifications for Participation

ENACCT is seeking applications from any cancer treating institution already involving patient navigators in the cancer clinical trial setting. Both Canadian and U.S. based institutions are welcome to apply. Three sites will be selected:

  1. U.S. based lay navigator program (navigation by a paid staff member with no formal health professional training)
  2. U.S. based professionally led navigator program (navigation by a paid staff member with any type of health professional training)
  3. Canadian based lay or professionally led program

In addition, the institution must meet the following criteria to be eligible:

  • At least 500 newly diagnosed cancer patients annually
  • Navigators (lay or professional) working as paid staff with a focus on cancer treatment trials for at least six months
  • Strong navigator integration with the clinical research team
  • Willingness to be trained in communication around clinical trials as well as question listing and patient activation
  • Willingness to participate in monthly project calls
  • Willingness to submit data on a monthly basis
  • Integration of other navigation services (e.g. access to transportation, insurance, psychosocial services) for patients considering clinical trial participation




Patient Navigation in Cancer Treatment Clinical Trials_Information Package.pdf314.88 KB
Patient Navigation in Cancer Treatment Clinical Trials_Application Form.doc171 KB
Patient Navigation in Cancer Treatmen Clinical Trials_ Catchment Area Chart Appendix_Form.doc62 KB