Evidence map›Paper›PMID 25873253›Full record

ArticleCancer2015

Practical communication guidance to improve phase 1 informed consent conversations and decision-making in pediatric oncology.

Liza-Marie Johnson, Angela C Leek, Dennis Drotar, Robert B Noll, Susan R Rheingold, Eric D Kodish, Justin N Baker

Abstract read
In one paragraph

Article in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Moving toward precision communication in pediatric oncology clinical trials: An outline of a conceptual framework to support caregiver decision-making.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  2. Article
  3. Review
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  5. Review
  6. Review
  7. Article
  8. Ethical Challenges in Pediatric Oncology Care and Clinical Trials.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2021
    Article
  9. Article
  10. Inclusion of children in the initial conversation about their cancer diagnosis: impact on parent experiences of the communication process.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Article
  11. Review
  12. Review
  13. Observational
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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

7 authors.

Liza-Marie JohnsonDivision of Quality of Life and Palliative Care, St. Jude Children's Research Hospital, Memphis, Tennessee.
Angela C LeekDepartment of Bioethics, Cleveland Clinic, Cleveland, Ohio.
Dennis DrotarDepartment of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Robert B NollDivision of Developmental and Behavioral Pediatrics, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.
Susan R RheingoldDivision of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Eric D KodishCenter for Ethics, Humanities, and Spiritual Care, Cleveland Clinic, Cleveland, Ohio.
Justin N BakerDivision of Quality of Life and Palliative Care, St. Jude Children's Research Hospital, Memphis, Tennessee.

Funding

Informed Consent in Pediatric Phase I Cancer TrialsR01CA122217 · NCI · CLEVELAND CLINIC LERNER COM-CWRU · PI KODISH, ERIC D. · 2007 to 2011
$3.3M
NCI NIH HHS 1R01CA122217NCI NIH HHS R01 CA122217
6 · The paper itself

Abstract

backgroundIt can be difficult to explain pediatric phase 1 oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions.

methodsSuggestions for improving the informed consent process were first solicited from phase 1 study clinicians via questionnaire. Eight parents who had enrolled their child on a phase 1 pediatric oncology trial were recruited for an advisory group designed to assess the clinicians' suggestions and make additional recommendations for improving informed consent for pediatric phase 1 trials.

resultsA phase 1 communication model was designed to incorporate the suggestions of clinicians and families. It focused on educating parents/families about phase 1 trials at specific time points during a child's illness, but specifically at the point of disease recurrence. An informative phase 1 fact sheet that can be distributed to families was also presented.

conclusionsFamilies who will be offered information regarding phase 1 clinical trials can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be enhanced further when oncologists address key themes, beginning at the time of diagnosis and continuing through important decision points during the child's illness. This model should be prospectively evaluated.

Indexed as

CommunicationDecision MakingParental ConsentPhysician's RoleAdultChildComprehensionFemaleHumansMaleMiddle AgedPediatricsSurveys and Questionnairesethicspatient perspectivespediatric oncologyphysician communication

Identifiers

PMID25873253
PMCPMC4490010

What OpenQuestion holds

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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 OpenQuestion graph.