Evidence map›Paper›PMID 29685123›Full record

ArticleBMC cancer2018

The PiGeOn project: protocol of a longitudinal study examining psychosocial and ethical issues and outcomes in germline genomic sequencing for cancer.

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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Fear of cancer recurrence in patients undergoing germline genome sequencing.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Article
  6. Article
  7. 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), Level 6 North, Lifehouse (C39Z), University of Sydney, 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, Sydney, NSW, 2006, Australia.ORCID 0000-0002-3460-772X
Bettina MeiserPrince of Wales Clinical School, UNSW Sydney, Sydney, NSW, 2052, Australia.
Ilona JuraskovaCentre for Medical Psychology and Evidence-based Decision-making, School of Psychology (CeMPED - Psychology), University of Sydney, Sydney, NSW, 2006, Australia.ORCID 0000-0001-9396-4113
David GoldsteinPrince of Wales Clinical School, UNSW Sydney, Sydney, NSW, 2052, Australia.ORCID 0000-0001-6142-3291
Kathy TuckerHereditary Cancer Centre, Prince of Wales Hospital, Sydney, NSW, 2052, Australia.
Mandy L BallingerCancer Division, Garvan Institute of Medical Research, 384 Victoria St, Darlinghurst, NSW, 2021, Australia.ORCID 0000-0002-9706-0514
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, Sydney, NSW, 2006, Australia.
Barbara BieseckerNational Human Genome Research, 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.ORCID 0000-0002-2527-5428
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, Sydney, NSW, 2006, Australia.
Chris JacobsPrince of Wales Clinical School, UNSW Sydney, Sydney, NSW, 2052, Australia.
Phyllis ButowPsycho-oncology Co-operative Research Group (PoCoG), Level 6 North, Lifehouse (C39Z), University of Sydney, Sydney, NSW, 2006, Australia.ORCID 0000-0003-3562-6954

Funding

Interventions in Genetic CounselingZIAHG200317 · NHGRI · NATIONAL HUMAN GENOME RESEARCH INSTITUTE · PI BIESECKER, BARBARA BOWLES · 2009 to 2018
$7.6M
Cancer Institute NSW 2017/ECF002National Health and Medical Research Council APP1124749
6 · The paper itself

Abstract

backgroundAdvances in genomics offer promise for earlier detection or prevention of cancer, by personalisation of medical care tailored to an individual's genomic risk status. However genome sequencing can generate an unprecedented volume of results for the patient to process with potential implications for their families and reproductive choices. This paper describes a protocol for a study (PiGeOn) that aims to explore how patients and their blood relatives experience germline genomic sequencing, to help guide the appropriate future implementation of genome sequencing into routine clinical practice.

methodsWe have designed a mixed-methods, prospective, cohort sub-study of a germline genomic sequencing study that targets adults with cancer suggestive of a genetic aetiology. One thousand probands and 2000 of their blood relatives will undergo germline genomic sequencing as part of the parent study in Sydney, Australia between 2016 and 2020. Test results are expected within12-15 months of recruitment. For the PiGeOn sub-study, participants will be invited to complete surveys at baseline, three months and twelve months after baseline using self-administered questionnaires, to assess the experience of long waits for results (despite being informed that results may not be returned) and expectations of receiving them. Subsets of both probands and blood relatives will be purposively sampled and invited to participate in three semi-structured qualitative interviews (at baseline and each follow-up) to triangulate the data. Ethical themes identified in the data will be used to inform critical revisions of normative ethical concepts or frameworks. DISCUSSION: This will be one of the first studies internationally to follow the psychosocial impact on probands and their blood relatives who undergo germline genome sequencing, over time. Study results will inform ongoing ethical debates on issues such as informed consent for genomic sequencing, and informing participants and their relatives of specific results. The study will also provide important outcome data concerning the psychological impact of prolonged waiting for germline genomic sequencing. These data are needed to ensure that when germline genomic sequencing is introduced into standard clinical settings, ethical concepts are embedded, and patients and their relatives are adequately prepared and supported during and after the testing process.

Indexed as

Clinical ProtocolsGenomicsWhole Genome SequencingAnxietyAustraliaDepressionDisease SusceptibilityFamilyFearGerm CellsHealth Knowledge, Attitudes, PracticeHumansLongitudinal StudiesNeoplasmsPerceptionSurveys and QuestionnairesCancerEthical issuesGenetic testingGenomicsGermline genomic sequencingNeoplasmPsychosocial factors

Identifiers

PMID29685123
PMCPMC5914013

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.