Evidence mapPaperPMID 40080789Full record

ArticleJCO oncology practice2025

System-Level Transformations to Increase Patient Participation in Clinical Trials.

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 and 4 more

Abstract read
In one paragraph

Article in JCO oncology practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Nicole E CastonDepartment of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham (UAB), Birmingham, AL.ORCID 0000-0001-7474-6110
Luqin DengUniversity of Alabama at Birmingham, Division of Preventive Medicine, Birmingham, AL.
Courtney P WilliamsUniversity of Alabama at Birmingham, Division of Preventive Medicine, Birmingham, AL.ORCID 0000-0001-5328-7517
Emily B LevitanUniversity of Alabama at Birmingham, Department of Epidemiology, Birmingham, AL.ORCID 0000-0002-5429-3852
Andres AzueroUniversity of Alabama at Birmingham, School of Nursing, Birmingham, AL.ORCID 0000-0001-9883-1424
Russell GriffinUniversity of Alabama at Birmingham, Department of Epidemiology, Birmingham, AL.
Karen L SmithMerck, Rahway, NJ.ORCID 0000-0002-6687-0119
Antonio C WolffJohns Hopkins University Sidney Kimmel Cancer Center, Baltimore, MD.ORCID 0000-0003-3734-1063
Michelle E MeliskoDepartment of Medicine, Division of Hematology and Oncology, University of California San Francisco, San Francisco, CA.ORCID 0000-0002-8729-4667
Eileen H ShinnDepartment of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-3220-7423
Kathleen GallagherPatient Advocate Foundation, Hampton, VA.ORCID 0000-0003-3315-8720
Rebekah AngovePatient Advocate Foundation, Hampton, VA.ORCID 0000-0003-3832-1670
Stephanie B WheelerDepartment of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0002-3399-9047
Gabrielle B RocqueDepartment of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham (UAB), Birmingham, AL.ORCID 0000-0003-4188-9785

Funding

XRAY CRYSTALLOGRAPHYP30CA013148 · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 1985 to 2025
$36.9M
Cancer Care Quality Training ProgramT32CA116339 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · 2023 to 2025
$800k
NCI NIH HHS P30 CA013148NCI NIH HHS T32 CA116339
6 · The paper itself

Abstract

purposeOver the course of the COVID-19 pandemic, the Food and Drug Administration allowed cancer clinical trials to make modifications. As policymakers consider sustaining these modifications, understanding patient perspectives on impact is critical.

methodsThis cross-sectional study used survey data collected between August 2021 and September 2021 by the Translational Breast Cancer Research Consortium and December 2022 by Patient Advocate Foundation among female breast cancer survivors. Respondents reported how changes to location, telemedicine, convenience, and opting out of certain procedures would affect their willingness to participate in a trial. Respondents' county-level vulnerability was determined using five-digit Federal Information Processing Standard codes to link to the Social Vulnerability Index (SVI) overall theme (range, 0-1). According to the SVI, the most vulnerable counties are those in the upper 10% of the overall theme. Model-estimated odds ratios (ORs) and 95% CIs were estimated using multinomial logistic regression models to explore the association between county-level social vulnerability and willingness to participate.

resultsOverall, 573 women were included, 12% lived in the most vulnerable counties, and 18% had previous trial participation. Over half (53%) reported that they would be very willing to participate in a trial that offered medication delivery to the home. When compared with all other counties, respondents in most vulnerable counties did not have increased willingness to participate in a trial using telemedicine (OR, 0.21 [95% CI, 0.07 to 0.63]). Results were similar for all other trial modifications, though not statistically significant.

conclusionOur sample of breast cancer survivors viewed trial modifications favorably. However, respondents in the most vulnerable counties were less likely to be influenced by these modifications. Research is needed to understand if additional modifications would influence participation of this vulnerable population.

Indexed as

Breast NeoplasmsClinical Trials as TopicCOVID-19Patient ParticipationAdultAgedCancer SurvivorsCross-Sectional StudiesFemaleHumansMiddle AgedSARS-CoV-2Surveys and Questionnaires

Identifiers

PMID40080789
PMCPMC12353059

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.