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Facilitation of Enrollment onto Cancer Clinical Trials Using a Novel Navigator-Assisted Program: A Cross-Sectional
Mahmoud Hossami1, Rhonda Abdel-Nabi1, Farwa Zaib2
1Faculty of Biomedical Science, University of Windsor, Windsor, ON N9B 3P4, Canada.
Introduction:
Clinical trials are essential to the advancement of clinical therapies that improve the outcomes of people with cancer. However, enrollment in clinical trials remains a challenge. The Clinical Trial Navigator [CTN] Program was designed to address the current gap in the cancer care journey by assisting with the clinical trials search process.
Methods:
Between March 2019 and July 2024, applicants of the CTN program included people with cancer, their family members, and/or their care team. Applicants entered the CTN program through a REDCap® survey that collected the patient's medical history. A final curated list of potential clinical trials was provided to the applicant. Metrics of success included clinical trial referral and enrollment, and we examined the factors that impacted these outcomes.
Results:
A total of 445 people with cancer applied to the CTN program during the study. Of the 262 patients with referral and enrollment information, a trial referral occurred in 27.5% [n = 72]. Of the 72 patients who were referred to a clinical trial, 13 [18.1%] were enrolled, 9 [12.5%] are pending enrollment, and 50 [69.4%] were not enrolled. We identified a potential trial for 88% of applicants, with a median of one potential trial per patient. Physicians were highly involved as applicants.
Interpretation:
The CTN program is successful in searching for clinical trials for people with cancer. Ongoing implementation into other Canadian sites, assessments of patient-reported outcomes, website and social media campaigns, and research into the factors that impact referral and enrollment are underway.
Insights
The Clinical Trial Navigator (CTN) program successfully identifies potential cancer clinical trials for patients. This program aids in trial referrals and enrollment, addressing a critical gap in cancer care.
Area of Science:
- Oncology
- Clinical Research
- Health Informatics
Background:
- Clinical trials are crucial for advancing cancer therapies and improving patient outcomes.
- Patient enrollment in clinical trials presents significant challenges.
- The Clinical Trial Navigator (CTN) program was developed to bridge the gap in the cancer care journey by facilitating the clinical trial search process.
Purpose of the Study:
- To evaluate the effectiveness of the Clinical Trial Navigator (CTN) program in identifying and facilitating clinical trial enrollment for cancer patients.
- To analyze factors influencing clinical trial referral and enrollment rates within the CTN program.
Main Methods:
- The CTN program utilized a REDCap survey to collect patient medical history from individuals with cancer, their families, and care teams between March 2019 and July 2024.
- Applicants received a curated list of potential clinical trials.
- Key success metrics included clinical trial referral and enrollment rates.
Main Results:
- A total of 445 individuals with cancer applied to the CTN program.
- A potential trial was identified for 88% of applicants, with a median of one trial per patient.
- Of 262 patients with available data, 27.5% received a trial referral, and 18.1% of those referred were enrolled.
Conclusions:
- The CTN program demonstrates success in assisting cancer patients with clinical trial searches.
- Further implementation across Canadian sites, patient-reported outcome assessments, and expanded outreach are planned.
- Continued research is necessary to understand factors impacting trial referral and enrollment.
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