Evidence map›Paper›PMID 22382459›Full record

ArticleThe oncologist2012

Evaluation of an educational program to improve communication with patients about early-phase trial participation.

Lesley J Fallowfield, Ivonne Solis-Trapala, Valerie A Jenkins

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in The oncologist, 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 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. "Get the Consent"-Nonfinancial Conflict of Interest in Academic Clinical Research.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017
    Article
  13. Article
  14. Article
  15. Article
  16. American Society of Clinical Oncology policy statement update: the critical role of phase I trials in cancer research and treatment.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Article
  17. Article
  18. Article
  19. Article
  20. Digital Tools and Strategies for Engaging Patients in Cancer Clinical Trials.Cancer control : journal of the Moffitt Cancer Center
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Lesley J FallowfieldSussex Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex, Medical School, University of Sussex, Falmer, Brighton, BN1 9QG, UK.
Ivonne Solis-Trapala
Valerie A Jenkins
University of Sussex · GBLancaster University · GB

Funding

Medical Research Council G0701642Medical Research Council MC_EX_G0701642/2
6 · The paper itself

Abstract

backgroundDiscussing early-phase cancer trials is challenging; most offer little personal benefit to patients with life-limiting illnesses who frequently have a poor understanding of and misconceptions about the therapeutic aims. We evaluated an evidence-based training program aimed at enhancing communication.

methodsPrior to and after the intervention, 47 health care professionals (HCPs) experienced in early-phase trial recruitment were audio taped discussing trials with patient simulators who completed postinterview evaluations. Coders rated the interviews for the presence of information areas required to elicit ethical consent. HCPs reported their self-confidence on 15 different aspects of trial discussion.

resultsSignificant objective and subjective improvements in communication were found after the workshop. Analyses of audio tapes showed positive shifts in: establishing the patient's knowledge of their prognosis (odds ratio [OR], 2.7; p = .002), discussing symptomatic care (OR, 3.8; p < .001), the aims of the trial (OR, 2.6; p =.002), and the unlikelihood of medical benefit (OR, 3.0; p = .021). Patient simulator ratings showed improvements in: the awareness of palliative care and symptom control (OR, 2.1; p = .004), the voluntariness of participation (OR, 3.7; p = .015), the opportunity to ask questions (OR, 2.9; p = .044), and the time to consider participation (OR, 6.1; p = .009). HCPs' self-confidence increased significantly for all 15 items (OR range, 1.5-2.9; p ≤ .001).

conclusionThis short, intensive workshop changed communication skills competency and self-efficacy in ways likely to promote valid, ethically informed consent from patients contemplating trial entry.

Indexed as

Clinical Trials as TopicPatient Education as TopicHumansPatient Participation

Identifiers

PMID22382459
PMCPMC3316923
OpenAlexW2099687111

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.