Evidence map›Paper›PMID 28249847›Full record

Trial reportBMJ open2017

Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials.

Martin H N Tattersall, Michael Jefford, Andrew Martin, Ian Olver, John F Thompson, Richard F Brown, Phyllis N Butow

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2017. 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 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 24% of its field
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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
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

7 authors at 6 institutions in 2 countries.

Martin H N TattersallSydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
Michael JeffordDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Andrew MartinNational Health and Research Council, Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Ian OlverRoyal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia.
John F ThompsonMelanoma Institute Australia, Royal Prince Alfred Hospital and the University of Sydney, Camperdown, New South Wales, Australia.
Richard F BrownDepartment of Health Behaviour and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
Phyllis N ButowCentre for Medical Psychology and Evidence-Based Decision-Making, School of Psychology, University of Sydney, Camperdown, New South Wales, Australia.
University of Sydney · AUMelanoma Institute Australia · AUNational Health and Medical Research Council · AURoyal Adelaide Hospital · AUUniversity of Melbourne · AUVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials.

settingTertiary cancer referral hospitals in three state capital cities in Australia.

participants88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an unblinded randomised trial of provision of a clinical trial question prompt list (QPL) before consenting to enrol in the treatment trial.

interventionsWe developed and pilot tested a targeted QPL for patients with cancer considering clinical trial participation (the clinical trial QPL). Consenting patients were randomised to receive the clinical trial QPL or not before further discussion with their oncologist and/or trial nurse about the treatment trial. PRIMARY AND SECONDARY OUTCOMES: Questionnaires were completed at baseline and within 3 weeks of deciding on treatment trial participation.

main outcome measurescores on the Quality of Informed Consent questionnaire (QuIC).

results88 patients of 130 sought for the study were enrolled (43 males), and 45 received the clinical trial QPL. 49% of trials were chemotherapy interventions for patients with advanced disease, 35% and 16% were surgical adjuvant and radiation adjuvant trials respectively. 70 patients completed all relevant questionnaires. 28 of 43 patients in the control arm compared with 39 of 45 patients receiving the clinical trial QPL completed the QuIC (p=0.0124). There were no significant differences in the QuIC scores between the randomised groups (QuIC part A p=0.08 and QuIC part B p=0.92). There were no differences in patient satisfaction with decisions or in anxiety levels between the randomised groups.

conclusionsUse of a question prompt list did not significantly change the QuIC scores in this randomised trial. ANZCTR 12606000214538 prospectively registered 31/5/2006. TRIAL REGISTRATION NUMBER: Results, ACTRN12606000214538.

Indexed as

Biomedical ResearchPatient ParticipationAgedAustraliaClinical Trials, Phase III as TopicFemaleHumansInformed ConsentMaleMiddle AgedNeoplasmsPatient SatisfactionSurveys and QuestionnairesTertiary Care CentersInformed Consent QuestionnaireQuestion Prompt List

Identifiers

PMID28249847
PMCPMC5353332
OpenAlexW2592125547

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.