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Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants

BACKGROUND: The National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute’s designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding their success. Cancer centers that cater to rural...

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Autores principales: Mudaranthakam, Dinesh Pal, Gajewski, Byron, Krebill, Hope, Coulter, James, Springer, Michelle, Calhoun, Elizabeth, Hughes, Dorothy, Mayo, Matthew, Doolittle, Gary
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9073606/
https://www.ncbi.nlm.nih.gov/pubmed/35451964
http://dx.doi.org/10.2196/33240
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author Mudaranthakam, Dinesh Pal
Gajewski, Byron
Krebill, Hope
Coulter, James
Springer, Michelle
Calhoun, Elizabeth
Hughes, Dorothy
Mayo, Matthew
Doolittle, Gary
author_facet Mudaranthakam, Dinesh Pal
Gajewski, Byron
Krebill, Hope
Coulter, James
Springer, Michelle
Calhoun, Elizabeth
Hughes, Dorothy
Mayo, Matthew
Doolittle, Gary
author_sort Mudaranthakam, Dinesh Pal
collection PubMed
description BACKGROUND: The National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute’s designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding their success. Cancer centers that cater to rural populations, such as The University of Kansas Cancer Center, have an additional responsibility to ensure rural residents have access and are well represented across these studies. OBJECTIVE: There are scant data available regarding the factors that act as barriers to the accrual of rural residents in these clinical trials. This study aims to use electronic screening logs that were used to gather patient data at several participating sites in The Kansas University of Cancer Center’s Catchment area. METHODS: Screening log data were used to assess what clinical trial participation barriers are faced by these patients. Additionally, the differences in clinical trial participation barriers were compared between rural and urban participating sites. RESULTS: Analysis revealed that the hospital location rural urban category, defined as whether the hospital was in an urban or rural setting, had a medium effect on enrolment of patients in breast cancer and lung cancer trials (Cohen d=0.7). Additionally, the hospital location category had a medium effect on the proportion of recurrent lung cancer cases at the time of screening (d=0.6). CONCLUSIONS: In consideration of the financially hostile nature of cancer treatment as well as geographical and transportation barriers, clinical trials extended to rural communities are uniquely positioned to alleviate the burden of nonmedical costs in trial participation. However, these options can be far less feasible for patients in rural settings. Since the number of patients with cancer who are eligible for a clinical trial is already limited by the stringent eligibility criteria required of such a complex disease, improving accessibility for rural patients should be a greater focus in health policy.
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spelling pubmed-90736062022-05-07 Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants Mudaranthakam, Dinesh Pal Gajewski, Byron Krebill, Hope Coulter, James Springer, Michelle Calhoun, Elizabeth Hughes, Dorothy Mayo, Matthew Doolittle, Gary JMIR Cancer Original Paper BACKGROUND: The National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute’s designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding their success. Cancer centers that cater to rural populations, such as The University of Kansas Cancer Center, have an additional responsibility to ensure rural residents have access and are well represented across these studies. OBJECTIVE: There are scant data available regarding the factors that act as barriers to the accrual of rural residents in these clinical trials. This study aims to use electronic screening logs that were used to gather patient data at several participating sites in The Kansas University of Cancer Center’s Catchment area. METHODS: Screening log data were used to assess what clinical trial participation barriers are faced by these patients. Additionally, the differences in clinical trial participation barriers were compared between rural and urban participating sites. RESULTS: Analysis revealed that the hospital location rural urban category, defined as whether the hospital was in an urban or rural setting, had a medium effect on enrolment of patients in breast cancer and lung cancer trials (Cohen d=0.7). Additionally, the hospital location category had a medium effect on the proportion of recurrent lung cancer cases at the time of screening (d=0.6). CONCLUSIONS: In consideration of the financially hostile nature of cancer treatment as well as geographical and transportation barriers, clinical trials extended to rural communities are uniquely positioned to alleviate the burden of nonmedical costs in trial participation. However, these options can be far less feasible for patients in rural settings. Since the number of patients with cancer who are eligible for a clinical trial is already limited by the stringent eligibility criteria required of such a complex disease, improving accessibility for rural patients should be a greater focus in health policy. JMIR Publications 2022-04-21 /pmc/articles/PMC9073606/ /pubmed/35451964 http://dx.doi.org/10.2196/33240 Text en ©Dinesh Pal Mudaranthakam, Byron Gajewski, Hope Krebill, James Coulter, Michelle Springer, Elizabeth Calhoun, Dorothy Hughes, Matthew Mayo, Gary Doolittle. Originally published in JMIR Cancer (https://cancer.jmir.org), 21.04.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Cancer, is properly cited. The complete bibliographic information, a link to the original publication on https://cancer.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Mudaranthakam, Dinesh Pal
Gajewski, Byron
Krebill, Hope
Coulter, James
Springer, Michelle
Calhoun, Elizabeth
Hughes, Dorothy
Mayo, Matthew
Doolittle, Gary
Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants
title Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants
title_full Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants
title_fullStr Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants
title_full_unstemmed Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants
title_short Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants
title_sort barriers to clinical trial participation: comparative study between rural and urban participants
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9073606/
https://www.ncbi.nlm.nih.gov/pubmed/35451964
http://dx.doi.org/10.2196/33240
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