TY - JOUR
T1 - Transferring care to enhance access to early-phase cancer clinical trials
T2 - Protocol to evaluate a novel program
AU - Nwachukwu, Chika
AU - Makhnoon, Sukh
AU - Person, Marieshia
AU - Muthukrishnan, Meera
AU - Kazmi, Syed
AU - Anderson, Larry D.
AU - Kaur, Gurbakhash
AU - Kapinos, Kandice A.
AU - Williams, Erin L.
AU - Fatunde, Oluwatomilade
AU - Sadeghi, Navid
AU - Robles, Fabian
AU - Basey, Alice
AU - Hulsey, Thomas
AU - Pruitt, Sandi L.
AU - Gerber, David E.
N1 - Publisher Copyright:
© 2024
PY - 2024/6
Y1 - 2024/6
N2 - Involving diverse populations in early-phase (phase I and II) cancer clinical trials is critical to informed therapeutic development. However, given the growing costs and complexities of early-phase trials, trial activation and enrollment barriers may be greatest for these studies at healthcare facilities that provide care to the most diverse patient groups, including those in historically underserved communities (e.g., safety-net healthcare systems). To promote diverse and equitable access to early-phase cancer clinical trials, we are implementing a novel program for the transfer of care to enhance access to early-phase cancer clinical trials. We will then perform a mixed-methods study to determine perceptions and impact of the program. Specifically, we will screen, recruit, and enroll diverse patients from an urban, integrated safety-net healthcare system to open and active early-phase clinical trials being conducted in a university-based cancer center. To evaluate this novel program, we will: (1) determine program impact and efficiency; and (2) determine stakeholder experience with and perceptions of the program. To achieve these goals, we will conduct preliminary cost analyses of the program. We will also conduct surveys and interviews with patients and caregivers to elucidate program impact, challenges, and areas for improvement. We hypothesize that broadening access to early-phase cancer trials conducted at experienced centers may improve equity and diversity. In turn, such efforts may enhance the efficiency and generalizability of cancer clinical research.
AB - Involving diverse populations in early-phase (phase I and II) cancer clinical trials is critical to informed therapeutic development. However, given the growing costs and complexities of early-phase trials, trial activation and enrollment barriers may be greatest for these studies at healthcare facilities that provide care to the most diverse patient groups, including those in historically underserved communities (e.g., safety-net healthcare systems). To promote diverse and equitable access to early-phase cancer clinical trials, we are implementing a novel program for the transfer of care to enhance access to early-phase cancer clinical trials. We will then perform a mixed-methods study to determine perceptions and impact of the program. Specifically, we will screen, recruit, and enroll diverse patients from an urban, integrated safety-net healthcare system to open and active early-phase clinical trials being conducted in a university-based cancer center. To evaluate this novel program, we will: (1) determine program impact and efficiency; and (2) determine stakeholder experience with and perceptions of the program. To achieve these goals, we will conduct preliminary cost analyses of the program. We will also conduct surveys and interviews with patients and caregivers to elucidate program impact, challenges, and areas for improvement. We hypothesize that broadening access to early-phase cancer trials conducted at experienced centers may improve equity and diversity. In turn, such efforts may enhance the efficiency and generalizability of cancer clinical research.
KW - Cancer clinical trials
KW - Diversity
KW - Enrollment
KW - Phase 1
KW - Safety-net
UR - http://www.scopus.com/inward/record.url?scp=85189887171&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2024.101292
DO - 10.1016/j.conctc.2024.101292
M3 - Article
C2 - 38623454
AN - SCOPUS:85189887171
SN - 2451-8654
VL - 39
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 101292
ER -