Evidence map›Paper›PMID 22009665›Full record

Trial reportCancer2012

"Entering a Clinical Trial: Is it Right for You?": a randomized study of The Clinical Trials Video and its impact on the informed consent process.

Brianna Hoffner, Susan Bauer-Wu, Suzanne Hitchcock-Bryan, Mark Powell, Andrew Wolanski, Steven Joffe

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04407676 (A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials), which is not on this map. Cited by 21 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 6 pooled it
–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.

NCT04407676 naunknown statusnot on this mapstarted 2020, after this paper: background citation

A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2020 to 2023Enrolled34ConditionsSolid NeoplasmsArmsSummary PIS and Online Video Modules
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Decision aids for people considering taking part in clinical trials.The Cochrane database of systematic reviews · 2015
    Pooled it
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  9. Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
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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

6 authors.

Brianna HoffnerBone Marrow Transplant and Hematologic Malignancies, University of Colorado School of Medicine, University of Colorado Hospital, Denver, Colorado, USA. bhoffner@gmail.com
Susan Bauer-Wu
Suzanne Hitchcock-Bryan
Mark Powell
Andrew Wolanski
Steven Joffe

Funding

Human Subjects Research Protections Outreach ProjectS07RR018207 · NCRR · DANA-FARBER CANCER INSTITUTE · PI ROLLINS, BARRETT J. · 2002 to 2003
$500k
NCRR NIH HHS 2S07RR18207-02NCRR NIH HHS S07 RR018207
6 · The paper itself

Abstract

purposeThis randomized study was designed to assess the utility of an educational video in preparing cancer patients for decisions about clinical trial participation. The study assessed the effect of the video on patients' understanding and perceptions of clinical trials, its impact on decision making and patient-provider communication, and patients' satisfaction with the video.

methodsNinety adults considering cancer clinical trials were randomized to receive (n = 45) or not receive (n = 45) the video. Using the validated Quality of Informed Consent (QuIC), respondents' knowledge about clinical trial participation was assessed. All subjects completed additional questions about satisfaction with the video, decision making, and patient-provider communication. Data were analyzed using the Wilcoxon rank-sum test, regression model, and descriptive statistics.

resultsAlthough intent-to-treat analysis found no significant group differences in objective understanding between those randomized to view or not view the video, the majority of participants reported favorable experiences with regard to watching the video: 85% found the video was an important source of information about clinical trials; 81% felt better prepared to discuss the trial with their physician; 89% of those who watched the video with family indicated that it helped family better understand clinical trials; and 73% indicated it helped family accept their decision about participation.

conclusionsAlthough the video did not measurably improve patients' knowledge about clinical trials, it was an important source of information, helped educate families, and enhanced patient communication with their oncology providers.

Indexed as

Clinical Trials as TopicInformed ConsentVideotape RecordingAdultAgedCommunicationDecision MakingFemaleHumansMaleMiddle AgedNeoplasmsPatient Education as TopicPatient Satisfaction

Identifiers

PMID22009665
PMCPMC3262890

What OpenQuestion holds

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LicenceTDM
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Registered trials

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 OpenQuestion graph.