Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical Trial

ABSTRACT Background Although breast cancer (BC) clinical trials offer novel treatments, participating patients often do not represent populations seen in clinics. This study assessed how patient sociodemographics, attitudes, and knowledge about clinical trials may be associated with participation. M...

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Main Authors: Nicole E. Caston, Luqin Deng, Courtney P. Williams, Emily B. Levitan, Andres Azuero, Russell Griffin, Karen L. Smith, Antonio C. Wolff, Michelle E. Melisko, Eileen H. Shinn, Kathleen Gallagher, Rebekah Angove, Stephanie B. Wheeler, Gabrielle B. Rocque
Format: Article
Language:English
Published: Wiley 2025-08-01
Series:Cancer Medicine
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Online Access:https://doi.org/10.1002/cam4.71010
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author Nicole E. Caston
Luqin Deng
Courtney P. Williams
Emily B. Levitan
Andres Azuero
Russell Griffin
Karen L. Smith
Antonio C. Wolff
Michelle E. Melisko
Eileen H. Shinn
Kathleen Gallagher
Rebekah Angove
Stephanie B. Wheeler
Gabrielle B. Rocque
author_facet Nicole E. Caston
Luqin Deng
Courtney P. Williams
Emily B. Levitan
Andres Azuero
Russell Griffin
Karen L. Smith
Antonio C. Wolff
Michelle E. Melisko
Eileen H. Shinn
Kathleen Gallagher
Rebekah Angove
Stephanie B. Wheeler
Gabrielle B. Rocque
author_sort Nicole E. Caston
collection DOAJ
description ABSTRACT Background Although breast cancer (BC) clinical trials offer novel treatments, participating patients often do not represent populations seen in clinics. This study assessed how patient sociodemographics, attitudes, and knowledge about clinical trials may be associated with participation. Methods This cross sectional analysis used survey data collected August–September 2021 by Translational Breast Cancer Research Consortium (TBCRC) and December 2022 by Patient Advocate Foundation (PAF) among women with a BC diagnosis. Respondents reported BC clinical trial participation, Attitudes Toward Cancer Trials Scale, clinical trial knowledge, diagnosis age, race, education level, household income, employment status, and BC stage. Descriptive and bivariate analyses were conducted using Cramer's V or Cohen's d as effect sizes. Standardized total effects (bTot) were estimated using a prespecified Structural Equation Model with 0.1, 0.3, and 0.5 indicating weak, medium, and large magnitude, respectively. Results Of 612 respondents, 26% were Black, Indigenous, or a Person of Color, 44% < Bachelor's degree, and 48% had incomes < $50,000. Respondents who reported trial participation (18%) more often had positive attitudes toward trials (mean 94 of 126, SD 19.3 vs. 86, SD 15.5; d = 0.48) compared to those not reporting participation. Positive attitude was associated with trial participation for both survey cohorts (TBCRC: bTot = 0.22, p = 0.0002; PAF: bTot = 0.13, p = 0.01). Furthermore, clinical trial knowledge was associated with attitudes (TBCRC: bTot = 0.27, p = < 0.0001; PAF: bTot = 0.15, p = 0.003). Discussion Although we found that positive attitudes and high knowledge were associated with clinical trial participation, it is unknown if the trial itself directly affected this. However, trial enrollment may be increased and diversified via future interventions focused on promotion of positive attitudes toward clinical trials, potentially through increased trial education and knowledge.
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spelling doaj-art-e90a150114364e0691950455fb91390d2025-08-26T10:58:44ZengWileyCancer Medicine2045-76342025-08-011416n/an/a10.1002/cam4.71010Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical TrialNicole E. Caston0Luqin Deng1Courtney P. Williams2Emily B. Levitan3Andres Azuero4Russell Griffin5Karen L. Smith6Antonio C. Wolff7Michelle E. Melisko8Eileen H. Shinn9Kathleen Gallagher10Rebekah Angove11Stephanie B. Wheeler12Gabrielle B. Rocque13Division of Hematology and Oncology, Department of Medicine University of Alabama at Birmingham (UAB) Birmingham Alabama USADivision of Preventive Medicine UAB Birmingham Alabama USADivision of Preventive Medicine UAB Birmingham Alabama USADepartment of Epidemiology UAB Birmingham Alabama USASchool of Nursing UAB Birmingham Alabama USADepartment of Epidemiology UAB Birmingham Alabama USAMerck Rahway New Jersey USAJohns Hopkins University Sidney Kimmel Cancer Center Baltimore Maryland USADivision of Hematology and Oncology, Department of Medicine University of California San Francisco San Francisco California USADepartment of Behavioral Science University of Texas MD Anderson Cancer Center Houston Texas USAPatient Advocate Foundation Hampton Virginia USAPatient Advocate Foundation Hampton Virginia USADepartment of Health Policy and Management, Gillings School of Global Public Health University of North Carolina at Chapel Hill Chapel Hill North Carolina USADivision of Hematology and Oncology, Department of Medicine University of Alabama at Birmingham (UAB) Birmingham Alabama USAABSTRACT Background Although breast cancer (BC) clinical trials offer novel treatments, participating patients often do not represent populations seen in clinics. This study assessed how patient sociodemographics, attitudes, and knowledge about clinical trials may be associated with participation. Methods This cross sectional analysis used survey data collected August–September 2021 by Translational Breast Cancer Research Consortium (TBCRC) and December 2022 by Patient Advocate Foundation (PAF) among women with a BC diagnosis. Respondents reported BC clinical trial participation, Attitudes Toward Cancer Trials Scale, clinical trial knowledge, diagnosis age, race, education level, household income, employment status, and BC stage. Descriptive and bivariate analyses were conducted using Cramer's V or Cohen's d as effect sizes. Standardized total effects (bTot) were estimated using a prespecified Structural Equation Model with 0.1, 0.3, and 0.5 indicating weak, medium, and large magnitude, respectively. Results Of 612 respondents, 26% were Black, Indigenous, or a Person of Color, 44% < Bachelor's degree, and 48% had incomes < $50,000. Respondents who reported trial participation (18%) more often had positive attitudes toward trials (mean 94 of 126, SD 19.3 vs. 86, SD 15.5; d = 0.48) compared to those not reporting participation. Positive attitude was associated with trial participation for both survey cohorts (TBCRC: bTot = 0.22, p = 0.0002; PAF: bTot = 0.13, p = 0.01). Furthermore, clinical trial knowledge was associated with attitudes (TBCRC: bTot = 0.27, p = < 0.0001; PAF: bTot = 0.15, p = 0.003). Discussion Although we found that positive attitudes and high knowledge were associated with clinical trial participation, it is unknown if the trial itself directly affected this. However, trial enrollment may be increased and diversified via future interventions focused on promotion of positive attitudes toward clinical trials, potentially through increased trial education and knowledge.https://doi.org/10.1002/cam4.71010attitudes toward trialsbreast cancercancer clinical trialsclinical trial knowledgevulnerable populations
spellingShingle Nicole E. Caston
Luqin Deng
Courtney P. Williams
Emily B. Levitan
Andres Azuero
Russell Griffin
Karen L. Smith
Antonio C. Wolff
Michelle E. Melisko
Eileen H. Shinn
Kathleen Gallagher
Rebekah Angove
Stephanie B. Wheeler
Gabrielle B. Rocque
Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical Trial
Cancer Medicine
attitudes toward trials
breast cancer
cancer clinical trials
clinical trial knowledge
vulnerable populations
title Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical Trial
title_full Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical Trial
title_fullStr Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical Trial
title_full_unstemmed Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical Trial
title_short Understanding Associations Between Patient‐Level Factors and Participation in a Breast Cancer Clinical Trial
title_sort understanding associations between patient level factors and participation in a breast cancer clinical trial
topic attitudes toward trials
breast cancer
cancer clinical trials
clinical trial knowledge
vulnerable populations
url https://doi.org/10.1002/cam4.71010
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