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

Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Best, Megan [verfasserIn] Newson, Ainsley J. Meiser, Bettina Juraskova, Ilona Goldstein, David Tucker, Kathy Ballinger, Mandy L. Hess, Dominique Schlub, Timothy E. Biesecker, Barbara Vines, Richard Vines, Kate Thomas, David Young, Mary-Anne Savard, Jacqueline Jacobs, Chris Butow, Phyllis

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	Tumour genomic profiling Genome sequencing Germline sequencing Molecular profiling Cancer Psychosocial factors Health behaviors Ethical issues

Anmerkung:	© The Author(s). 2018

Übergeordnetes Werk:	Enthalten in: BMC cancer - London : BioMed Central, 2001, 18(2018), 1 vom: 05. Apr.
Übergeordnetes Werk:	volume:18 ; year:2018 ; number:1 ; day:05 ; month:04

Links:	Volltext

DOI / URN:	10.1186/s12885-018-4310-0

Katalog-ID:	SPR02769786X

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allfields	10.1186/s12885-018-4310-0 doi (DE-627)SPR02769786X (SPR)s12885-018-4310-0-e DE-627 ger DE-627 rakwb eng Best, Megan verfasserin (orcid)0000-0003-1570-8872 aut The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. Tumour genomic profiling (dpeaa)DE-He213 Genome sequencing (dpeaa)DE-He213 Germline sequencing (dpeaa)DE-He213 Molecular profiling (dpeaa)DE-He213 Cancer (dpeaa)DE-He213 Psychosocial factors (dpeaa)DE-He213 Health behaviors (dpeaa)DE-He213 Ethical issues (dpeaa)DE-He213 Newson, Ainsley J. aut Meiser, Bettina aut Juraskova, Ilona aut Goldstein, David aut Tucker, Kathy aut Ballinger, Mandy L. aut Hess, Dominique aut Schlub, Timothy E. aut Biesecker, Barbara aut Vines, Richard aut Vines, Kate aut Thomas, David aut Young, Mary-Anne aut Savard, Jacqueline aut Jacobs, Chris aut Butow, Phyllis aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 05. Apr. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:05 month:04 https://dx.doi.org/10.1186/s12885-018-4310-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2018 1 05 04
spelling	10.1186/s12885-018-4310-0 doi (DE-627)SPR02769786X (SPR)s12885-018-4310-0-e DE-627 ger DE-627 rakwb eng Best, Megan verfasserin (orcid)0000-0003-1570-8872 aut The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. Tumour genomic profiling (dpeaa)DE-He213 Genome sequencing (dpeaa)DE-He213 Germline sequencing (dpeaa)DE-He213 Molecular profiling (dpeaa)DE-He213 Cancer (dpeaa)DE-He213 Psychosocial factors (dpeaa)DE-He213 Health behaviors (dpeaa)DE-He213 Ethical issues (dpeaa)DE-He213 Newson, Ainsley J. aut Meiser, Bettina aut Juraskova, Ilona aut Goldstein, David aut Tucker, Kathy aut Ballinger, Mandy L. aut Hess, Dominique aut Schlub, Timothy E. aut Biesecker, Barbara aut Vines, Richard aut Vines, Kate aut Thomas, David aut Young, Mary-Anne aut Savard, Jacqueline aut Jacobs, Chris aut Butow, Phyllis aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 05. Apr. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:05 month:04 https://dx.doi.org/10.1186/s12885-018-4310-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2018 1 05 04
allfields_unstemmed	10.1186/s12885-018-4310-0 doi (DE-627)SPR02769786X (SPR)s12885-018-4310-0-e DE-627 ger DE-627 rakwb eng Best, Megan verfasserin (orcid)0000-0003-1570-8872 aut The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. Tumour genomic profiling (dpeaa)DE-He213 Genome sequencing (dpeaa)DE-He213 Germline sequencing (dpeaa)DE-He213 Molecular profiling (dpeaa)DE-He213 Cancer (dpeaa)DE-He213 Psychosocial factors (dpeaa)DE-He213 Health behaviors (dpeaa)DE-He213 Ethical issues (dpeaa)DE-He213 Newson, Ainsley J. aut Meiser, Bettina aut Juraskova, Ilona aut Goldstein, David aut Tucker, Kathy aut Ballinger, Mandy L. aut Hess, Dominique aut Schlub, Timothy E. aut Biesecker, Barbara aut Vines, Richard aut Vines, Kate aut Thomas, David aut Young, Mary-Anne aut Savard, Jacqueline aut Jacobs, Chris aut Butow, Phyllis aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 05. Apr. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:05 month:04 https://dx.doi.org/10.1186/s12885-018-4310-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2018 1 05 04
allfieldsGer	10.1186/s12885-018-4310-0 doi (DE-627)SPR02769786X (SPR)s12885-018-4310-0-e DE-627 ger DE-627 rakwb eng Best, Megan verfasserin (orcid)0000-0003-1570-8872 aut The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. Tumour genomic profiling (dpeaa)DE-He213 Genome sequencing (dpeaa)DE-He213 Germline sequencing (dpeaa)DE-He213 Molecular profiling (dpeaa)DE-He213 Cancer (dpeaa)DE-He213 Psychosocial factors (dpeaa)DE-He213 Health behaviors (dpeaa)DE-He213 Ethical issues (dpeaa)DE-He213 Newson, Ainsley J. aut Meiser, Bettina aut Juraskova, Ilona aut Goldstein, David aut Tucker, Kathy aut Ballinger, Mandy L. aut Hess, Dominique aut Schlub, Timothy E. aut Biesecker, Barbara aut Vines, Richard aut Vines, Kate aut Thomas, David aut Young, Mary-Anne aut Savard, Jacqueline aut Jacobs, Chris aut Butow, Phyllis aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 05. Apr. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:05 month:04 https://dx.doi.org/10.1186/s12885-018-4310-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2018 1 05 04
allfieldsSound	10.1186/s12885-018-4310-0 doi (DE-627)SPR02769786X (SPR)s12885-018-4310-0-e DE-627 ger DE-627 rakwb eng Best, Megan verfasserin (orcid)0000-0003-1570-8872 aut The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. Tumour genomic profiling (dpeaa)DE-He213 Genome sequencing (dpeaa)DE-He213 Germline sequencing (dpeaa)DE-He213 Molecular profiling (dpeaa)DE-He213 Cancer (dpeaa)DE-He213 Psychosocial factors (dpeaa)DE-He213 Health behaviors (dpeaa)DE-He213 Ethical issues (dpeaa)DE-He213 Newson, Ainsley J. aut Meiser, Bettina aut Juraskova, Ilona aut Goldstein, David aut Tucker, Kathy aut Ballinger, Mandy L. aut Hess, Dominique aut Schlub, Timothy E. aut Biesecker, Barbara aut Vines, Richard aut Vines, Kate aut Thomas, David aut Young, Mary-Anne aut Savard, Jacqueline aut Jacobs, Chris aut Butow, Phyllis aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 05. Apr. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:05 month:04 https://dx.doi.org/10.1186/s12885-018-4310-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2018 1 05 04
language	English
source	Enthalten in BMC cancer 18(2018), 1 vom: 05. Apr. volume:18 year:2018 number:1 day:05 month:04
sourceStr	Enthalten in BMC cancer 18(2018), 1 vom: 05. Apr. volume:18 year:2018 number:1 day:05 month:04
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Tumour genomic profiling Genome sequencing Germline sequencing Molecular profiling Cancer Psychosocial factors Health behaviors Ethical issues
isfreeaccess_bool	true
container_title	BMC cancer
authorswithroles_txt_mv	Best, Megan @@aut@@ Newson, Ainsley J. @@aut@@ Meiser, Bettina @@aut@@ Juraskova, Ilona @@aut@@ Goldstein, David @@aut@@ Tucker, Kathy @@aut@@ Ballinger, Mandy L. @@aut@@ Hess, Dominique @@aut@@ Schlub, Timothy E. @@aut@@ Biesecker, Barbara @@aut@@ Vines, Richard @@aut@@ Vines, Kate @@aut@@ Thomas, David @@aut@@ Young, Mary-Anne @@aut@@ Savard, Jacqueline @@aut@@ Jacobs, Chris @@aut@@ Butow, Phyllis @@aut@@
publishDateDaySort_date	2018-04-05T00:00:00Z
hierarchy_top_id	326643710
id	SPR02769786X
language_de	englisch
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spellingShingle	Best, Megan misc Tumour genomic profiling misc Genome sequencing misc Germline sequencing misc Molecular profiling misc Cancer misc Psychosocial factors misc Health behaviors misc Ethical issues The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling
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topic_title	The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling Tumour genomic profiling (dpeaa)DE-He213 Genome sequencing (dpeaa)DE-He213 Germline sequencing (dpeaa)DE-He213 Molecular profiling (dpeaa)DE-He213 Cancer (dpeaa)DE-He213 Psychosocial factors (dpeaa)DE-He213 Health behaviors (dpeaa)DE-He213 Ethical issues (dpeaa)DE-He213
topic	misc Tumour genomic profiling misc Genome sequencing misc Germline sequencing misc Molecular profiling misc Cancer misc Psychosocial factors misc Health behaviors misc Ethical issues
topic_unstemmed	misc Tumour genomic profiling misc Genome sequencing misc Germline sequencing misc Molecular profiling misc Cancer misc Psychosocial factors misc Health behaviors misc Ethical issues
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title	The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling
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title_full	The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling
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author_browse	Best, Megan Newson, Ainsley J. Meiser, Bettina Juraskova, Ilona Goldstein, David Tucker, Kathy Ballinger, Mandy L. Hess, Dominique Schlub, Timothy E. Biesecker, Barbara Vines, Richard Vines, Kate Thomas, David Young, Mary-Anne Savard, Jacqueline Jacobs, Chris Butow, Phyllis
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title_sort	pigeon project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling
title_auth	The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling
abstract	Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. © The Author(s). 2018
abstractGer	Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. © The Author(s). 2018
abstract_unstemmed	Background Genomic 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. Methods This 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 registration Not required for this sub-study, parent trial registration ACTRN12616000908437. © The Author(s). 2018
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title_short	The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling
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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. Methods This 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. 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