Evidence map›Paper›PMID 29621994›Full record

ArticleBMC cancer2018

The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling.

Megan Best, Ainsley J Newson, Bettina Meiser, Ilona Juraskova, David Goldstein, Kathy Tucker, Mandy L Ballinger, Dominique Hess, Timothy E Schlub, Barbara Biesecker and 7 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Ethical considerations for nurses working in rare cancer care: Focus on sarcoma.Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2024
    Article
  4. Article
  5. Return of comprehensive tumour genomic profiling results to advanced cancer patients: a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  6. Article
  7. Article
  8. Article
  9. Article
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

17 authors.

Megan BestPsycho-oncology Co-operative Research Group (PoCoG), University of Sydney, Level 6 North, Lifehouse (C39Z), Sydney, NSW, 2006, Australia. megan.best@sydney.edu.au.ORCID 0000-0003-1570-8872
Ainsley J NewsonSydney Health Ethics, Sydney School of Public Health, University of Sydney, Camperdown, NSW, 2006, Australia.
Bettina MeiserPrince of Wales Clinical School, UNSW Sydney, Sydney, NSW, 2052, Australia.
Ilona JuraskovaCentre for Medical Psychology and Evidence-based Decision-making (CeMPED - Psychology), University of Sydney, Camperdown, NSW, 2006, Australia.
David GoldsteinPrince of Wales Clinical School, UNSW Sydney, Sydney, NSW, 2052, Australia.
Kathy TuckerPrince of Wales Clinical School, UNSW Sydney, Sydney, NSW, 2052, Australia.
Mandy L BallingerCancer Division, Garvan Institute of Medical Research, 384 Victoria St, Darlinghurst, NSW, 2021, Australia.
Dominique HessCancer Division, Garvan Institute of Medical Research, 384 Victoria St, Darlinghurst, NSW, 2021, Australia.
Timothy E SchlubSydney School of Public Health, University of Sydney, Camperdown, NSW, 2006, Australia.
Barbara BieseckerThe National Human Genome Research Institute, National Institutes of Health, 31 Center Drive, MSC 2073, Bethesda, MD, 20892, USA.
Richard VinesRare Cancers, PO Box 440, Bowral, NSW, 2576, Australia.
Kate VinesRare Cancers, PO Box 440, Bowral, NSW, 2576, Australia.
David ThomasCancer Division, Garvan Institute of Medical Research, 384 Victoria St, Darlinghurst, NSW, 2021, Australia.
Mary-Anne YoungGenome One, Garvan Institute of Medical Research, 384 Victoria St, Darlinghurst, NSW, 2021, Australia.
Jacqueline SavardSydney Health Ethics, Sydney School of Public Health, University of Sydney, Camperdown, NSW, 2006, Australia.
Chris JacobsPrince of Wales Clinical School, UNSW Sydney, Sydney, NSW, 2052, Australia.
Phyllis ButowPsycho-oncology Co-operative Research Group (PoCoG), University of Sydney, Level 6 North, Lifehouse (C39Z), Sydney, NSW, 2006, Australia.

Funding

Interventions in Genetic CounselingZIAHG200317 · NHGRI · NATIONAL HUMAN GENOME RESEARCH INSTITUTE · PI BIESECKER, BARBARA BOWLES · 2009 to 2018
$7.6M
Cancer Institute NSW MB00352National Health and Medical Research Council App1124749
6 · The paper itself

Abstract

backgroundGenomic sequencing in cancer (both tumour and germline), and development of therapies targeted to tumour genetic status, hold great promise for improvement of patient outcomes. However, the imminent introduction of genomics into clinical practice calls for better understanding of how patients value, experience, and cope with this novel technology and its often complex results. Here we describe a protocol for a novel mixed-methods, prospective study (PiGeOn) that aims to examine patients' psychosocial, cognitive, affective and behavioural responses to tumour genomic profiling and to integrate a parallel critical ethical analysis of returning results.

methodsThis is a cohort sub-study of a parent tumour genomic profiling programme enrolling patients with advanced cancer. One thousand patients will be recruited for the parent study in Sydney, Australia from 2016 to 2019. They will be asked to complete surveys at baseline, three, and five months. Primary outcomes are: knowledge, preferences, attitudes and values. A purposively sampled subset of patients will be asked to participate in three semi-structured interviews (at each time point) to provide deeper data interpretation. Relevant ethical themes will be critically analysed to iteratively develop or refine normative ethical concepts or frameworks currently used in the return of genetic information. DISCUSSION: This will be the first Australian study to collect longitudinal data on cancer patients' experience of tumour genomic profiling. Findings will be used to inform ongoing ethical debates on issues such as how to effectively obtain informed consent for genomic profiling return results, distinguish between research and clinical practice and manage patient expectations. The combination of quantitative and qualitative methods will provide comprehensive and critical data on how patients cope with 'actionable' and 'non-actionable' results. This information is needed to ensure that when tumour genomic profiling becomes part of routine clinical care, ethical considerations are embedded, and patients are adequately prepared and supported during and after receiving results.

trial registrationNot required for this sub-study, parent trial registration ACTRN12616000908437 .

Indexed as

Clinical ProtocolsAdaptation, PsychologicalBioethical IssuesFemaleGenomicsHealth BehaviorHealth Knowledge, Attitudes, PracticeHumansMaleNeoplasmsResearch DesignCancerEthical issuesGenome sequencingGermline sequencingHealth behaviorsMolecular profilingPsychosocial factorsTumour genomic profiling

Identifiers

PMID29621994
PMCPMC5887192

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.