Accrual and retention of diverse patients in psychosocial cancer clinical trials

Abstract Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic,...

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Main Authors: Grace Ann Hanvey, Adaixa Padron, Elizabeth L. Kacel, Gabriel Cartagena, Kelsey C. Bacharz, Christina S. McCrae, Michael E. Robinson, Lori B. Waxenberg, Michael H. Antoni, Richard B. Berry, Gregory S. Schultz, Jacqueline Castagno, Deidre B. Pereira
Format: Article
Language:English
Published: Cambridge University Press 2022-01-01
Series:Journal of Clinical and Translational Science
Subjects:
Online Access:https://www.cambridge.org/core/product/identifier/S2059866122003806/type/journal_article
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author Grace Ann Hanvey
Adaixa Padron
Elizabeth L. Kacel
Gabriel Cartagena
Kelsey C. Bacharz
Christina S. McCrae
Michael E. Robinson
Lori B. Waxenberg
Michael H. Antoni
Richard B. Berry
Gregory S. Schultz
Jacqueline Castagno
Deidre B. Pereira
author_facet Grace Ann Hanvey
Adaixa Padron
Elizabeth L. Kacel
Gabriel Cartagena
Kelsey C. Bacharz
Christina S. McCrae
Michael E. Robinson
Lori B. Waxenberg
Michael H. Antoni
Richard B. Berry
Gregory S. Schultz
Jacqueline Castagno
Deidre B. Pereira
author_sort Grace Ann Hanvey
collection DOAJ
description Abstract Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers. Methods: Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored. Results: No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation. Discussion: These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs.
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spelling doaj.art-a147ce3680b24ae192b791527970c88a2023-03-09T12:31:04ZengCambridge University PressJournal of Clinical and Translational Science2059-86612022-01-01610.1017/cts.2022.380Accrual and retention of diverse patients in psychosocial cancer clinical trialsGrace Ann Hanvey0Adaixa Padron1Elizabeth L. Kacel2Gabriel Cartagena3Kelsey C. Bacharz4Christina S. McCrae5Michael E. Robinson6Lori B. Waxenberg7Michael H. Antoni8Richard B. Berry9Gregory S. Schultz10Jacqueline Castagno11Deidre B. Pereira12Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USADepartment of Psychology, University of Miami, Coral Gables, FL, USADivision of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL, USADepartment of Obstetrics and Gynecology, University of Florida, Gainesville, FL, USADepartment of Obstetrics and Gynecology, University of Florida, Gainesville, FL, USADepartment of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA Abstract Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers. Methods: Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored. Results: No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation. Discussion: These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs. https://www.cambridge.org/core/product/identifier/S2059866122003806/type/journal_articleCancerclinical trialsrecruitmentretentionhealth disparities
spellingShingle Grace Ann Hanvey
Adaixa Padron
Elizabeth L. Kacel
Gabriel Cartagena
Kelsey C. Bacharz
Christina S. McCrae
Michael E. Robinson
Lori B. Waxenberg
Michael H. Antoni
Richard B. Berry
Gregory S. Schultz
Jacqueline Castagno
Deidre B. Pereira
Accrual and retention of diverse patients in psychosocial cancer clinical trials
Journal of Clinical and Translational Science
Cancer
clinical trials
recruitment
retention
health disparities
title Accrual and retention of diverse patients in psychosocial cancer clinical trials
title_full Accrual and retention of diverse patients in psychosocial cancer clinical trials
title_fullStr Accrual and retention of diverse patients in psychosocial cancer clinical trials
title_full_unstemmed Accrual and retention of diverse patients in psychosocial cancer clinical trials
title_short Accrual and retention of diverse patients in psychosocial cancer clinical trials
title_sort accrual and retention of diverse patients in psychosocial cancer clinical trials
topic Cancer
clinical trials
recruitment
retention
health disparities
url https://www.cambridge.org/core/product/identifier/S2059866122003806/type/journal_article
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