Cargando…
The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care
BACKGROUND: Polygenic risk scores (PRSs) can predict the risk of colorectal cancer (CRC) and target screening more precisely than current guidelines using age and family history alone. Primary care, as a far-reaching point of healthcare and routine provider of cancer screening and risk information,...
Autores principales: | , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9513012/ https://www.ncbi.nlm.nih.gov/pubmed/36163034 http://dx.doi.org/10.1186/s13063-022-06734-7 |
_version_ | 1784797959643201536 |
---|---|
author | Saya, Sibel Boyd, Lucy Chondros, Patty McNamara, Mairead King, Michelle Milton, Shakira Lourenco, Richard De Abreu Clark, Malcolm Fishman, George Marker, Julie Ostroff, Cheri Allman, Richard Walter, Fiona M. Buchanan, Daniel Winship, Ingrid McIntosh, Jennifer Macrae, Finlay Jenkins, Mark Emery, Jon |
author_facet | Saya, Sibel Boyd, Lucy Chondros, Patty McNamara, Mairead King, Michelle Milton, Shakira Lourenco, Richard De Abreu Clark, Malcolm Fishman, George Marker, Julie Ostroff, Cheri Allman, Richard Walter, Fiona M. Buchanan, Daniel Winship, Ingrid McIntosh, Jennifer Macrae, Finlay Jenkins, Mark Emery, Jon |
author_sort | Saya, Sibel |
collection | PubMed |
description | BACKGROUND: Polygenic risk scores (PRSs) can predict the risk of colorectal cancer (CRC) and target screening more precisely than current guidelines using age and family history alone. Primary care, as a far-reaching point of healthcare and routine provider of cancer screening and risk information, may be an ideal location for their widespread implementation. METHODS: This trial aims to determine whether the SCRIPT intervention results in more risk-appropriate CRC screening after 12 months in individuals attending general practice, compared with standard cancer risk reduction information. The SCRIPT intervention consists of a CRC PRS, tailored risk-specific screening recommendations and a risk report for participants and their GP, delivered in general practice. Patients aged between 45 and 70 inclusive, attending their GP, will be approached for participation. For those over 50, only those overdue for CRC screening will be eligible to participate. Two hundred and seventy-four participants will be randomised to the intervention or control arms, stratified by general practice, using a computer-generated allocation sequence. The primary outcome is risk-appropriate CRC screening after 12 months. For those in the intervention arm, risk-appropriate screening is defined using PRS-derived risk; for those in the control arm, it is defined using family history and national screening guidelines. Timing, type and results of the previous screening are considered in both arms. Objective health service data will capture screening behaviour. Secondary outcomes include cancer-specific worry, risk perception, predictors of CRC screening behaviour, screening intentions and health service use at 1, 6 and 12 months post-intervention delivery. DISCUSSION: This trial aims to determine whether a PRS-derived personalised CRC risk estimate delivered in primary care increases risk-appropriate CRC screening. A future population risk-stratified CRC screening programme could incorporate risk assessment within primary care while encouraging adherence to targeted screening recommendations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000092897p. Registered on 1 February 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06734-7. |
format | Online Article Text |
id | pubmed-9513012 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-95130122022-09-27 The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care Saya, Sibel Boyd, Lucy Chondros, Patty McNamara, Mairead King, Michelle Milton, Shakira Lourenco, Richard De Abreu Clark, Malcolm Fishman, George Marker, Julie Ostroff, Cheri Allman, Richard Walter, Fiona M. Buchanan, Daniel Winship, Ingrid McIntosh, Jennifer Macrae, Finlay Jenkins, Mark Emery, Jon Trials Study Protocol BACKGROUND: Polygenic risk scores (PRSs) can predict the risk of colorectal cancer (CRC) and target screening more precisely than current guidelines using age and family history alone. Primary care, as a far-reaching point of healthcare and routine provider of cancer screening and risk information, may be an ideal location for their widespread implementation. METHODS: This trial aims to determine whether the SCRIPT intervention results in more risk-appropriate CRC screening after 12 months in individuals attending general practice, compared with standard cancer risk reduction information. The SCRIPT intervention consists of a CRC PRS, tailored risk-specific screening recommendations and a risk report for participants and their GP, delivered in general practice. Patients aged between 45 and 70 inclusive, attending their GP, will be approached for participation. For those over 50, only those overdue for CRC screening will be eligible to participate. Two hundred and seventy-four participants will be randomised to the intervention or control arms, stratified by general practice, using a computer-generated allocation sequence. The primary outcome is risk-appropriate CRC screening after 12 months. For those in the intervention arm, risk-appropriate screening is defined using PRS-derived risk; for those in the control arm, it is defined using family history and national screening guidelines. Timing, type and results of the previous screening are considered in both arms. Objective health service data will capture screening behaviour. Secondary outcomes include cancer-specific worry, risk perception, predictors of CRC screening behaviour, screening intentions and health service use at 1, 6 and 12 months post-intervention delivery. DISCUSSION: This trial aims to determine whether a PRS-derived personalised CRC risk estimate delivered in primary care increases risk-appropriate CRC screening. A future population risk-stratified CRC screening programme could incorporate risk assessment within primary care while encouraging adherence to targeted screening recommendations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000092897p. Registered on 1 February 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06734-7. BioMed Central 2022-09-27 /pmc/articles/PMC9513012/ /pubmed/36163034 http://dx.doi.org/10.1186/s13063-022-06734-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Saya, Sibel Boyd, Lucy Chondros, Patty McNamara, Mairead King, Michelle Milton, Shakira Lourenco, Richard De Abreu Clark, Malcolm Fishman, George Marker, Julie Ostroff, Cheri Allman, Richard Walter, Fiona M. Buchanan, Daniel Winship, Ingrid McIntosh, Jennifer Macrae, Finlay Jenkins, Mark Emery, Jon The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care |
title | The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care |
title_full | The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care |
title_fullStr | The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care |
title_full_unstemmed | The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care |
title_short | The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care |
title_sort | script trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9513012/ https://www.ncbi.nlm.nih.gov/pubmed/36163034 http://dx.doi.org/10.1186/s13063-022-06734-7 |
work_keys_str_mv | AT sayasibel thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT boydlucy thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT chondrospatty thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT mcnamaramairead thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT kingmichelle thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT miltonshakira thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT lourencoricharddeabreu thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT clarkmalcolm thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT fishmangeorge thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT markerjulie thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT ostroffcheri thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT allmanrichard thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT walterfionam thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT buchanandaniel thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT winshipingrid thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT mcintoshjennifer thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT macraefinlay thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT jenkinsmark thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT emeryjon thescripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT sayasibel scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT boydlucy scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT chondrospatty scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT mcnamaramairead scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT kingmichelle scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT miltonshakira scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT lourencoricharddeabreu scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT clarkmalcolm scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT fishmangeorge scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT markerjulie scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT ostroffcheri scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT allmanrichard scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT walterfionam scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT buchanandaniel scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT winshipingrid scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT mcintoshjennifer scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT macraefinlay scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT jenkinsmark scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare AT emeryjon scripttrialstudyprotocolforarandomisedcontrolledtrialofapolygenicriskscoretotailorcolorectalcancerscreeninginprimarycare |