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Published in: Trials 1/2021

Open Access 01-12-2021 | CAR T-Cell Therapy | Research

Hematologists’ barriers and enablers to screening and recruiting patients to a chimeric antigen receptor (CAR) T cell therapy trial: a theory-informed interview study

Authors: Gisell Castillo, Manoj Lalu, Sarah Asad, Madison Foster, Natasha Kekre, Dean Fergusson, Terry Hawrysh, Harold Atkins, Kednapa Thavorn, Joshua Montroy, Stuart Schwartz, Robert Holt, Raewyn Broady, Justin Presseau, on behalf of the GO CART team

Published in: Trials | Issue 1/2021

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Abstract

Background

Novel therapies often fail to reach the bedside due to low trial recruitment rates. Prior to conducting one of the first chimeric antigen receptor (CAR) T cell therapy trials in Canada, we used the Theoretical Domains Framework, a novel tool for identifying barriers and enablers to behavior change, to identify physician-related barriers and enablers to screening and recruiting patients for an early phase immunotherapy trial.

Methods

We conducted interviews with hematologists across Canada and used a directed content analysis to identify relevant domains reflecting the key factors that may affect screening and recruitment.

Results

In total, we interviewed 15 hematologists. Physicians expressed “cautious hope”; while expressing safety, feasibility, and screening criteria concerns, 14 out of 15 hematologists intended to screen for the trial (domains: knowledge, goals, beliefs about consequences, intentions). Physicians underscored the “challenging contexts,” identifying resources, workload, forgetting, and patient wait times to receive CAR T cells as key practical barriers to screening (domains: environmental context and resources, memory, attention and decision-making, behavioral regulation). They also highlighted “variability in roles and procedures” that may lead to missed trial candidates (domain: social and professional role). Left unaddressed, these barriers may undermine trial recruitment.

Conclusions

This study is among the first to use the Theoretical Domains Framework from the physician perspective to identify recruitment challenges to early phase trials and demonstrates the value of this approach for identifying barriers to screening and recruitment that may not otherwise have been elicited. This approach can optimize trial procedures and may serve to inform future promising early phase cancer therapy trials.

Trial registration

ClinicalTrials.gov Identifier: NCT03765177. Registered on December 5, 2018.
Appendix
Available only for authorised users
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Metadata
Title
Hematologists’ barriers and enablers to screening and recruiting patients to a chimeric antigen receptor (CAR) T cell therapy trial: a theory-informed interview study
Authors
Gisell Castillo
Manoj Lalu
Sarah Asad
Madison Foster
Natasha Kekre
Dean Fergusson
Terry Hawrysh
Harold Atkins
Kednapa Thavorn
Joshua Montroy
Stuart Schwartz
Robert Holt
Raewyn Broady
Justin Presseau
on behalf of the GO CART team
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-021-05121-y

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