TY - JOUR
T1 - P s ychological i mpact of the Gal leri test (sIG(n)al)
T2 - Protocol for a longitudinal evaluation of the psychological impact of receiving a cancer signal in the NHS-Galleri trial
AU - Marlow, Laura A.V.
AU - Schmeising-Barnes, Ninian
AU - Warwick, Jane
AU - Waller, Jo
N1 - Funding Information:
GRAIL, LLC funds full salaries of LAVM and NS-B, as well as 20% of J.Waller’s salary via a contract with King’s College London (KCL). J.Warwick is also supported by project funding from GRAIL, LLC through a KCL contract. This funding also covers article processing charges.
Funding Information:
GRAIL, LLC funds full salaries of LAVM and NS-B, as well as 20% of JW’s salary via a contract with King’s College London (KCL). JW is also supported by project funding from GRAIL, LLC through a KCL contract. This funding also covers article processing charges. All other authors report no conflicts of interest.
Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/7/21
Y1 - 2023/7/21
N2 - Introduction Multi-cancer early detection (MCED) blood tests look for cancer signals in cell-free deoxyribonucleic acid. These tests have the potential to detect cancers at an earlier (asymptomatic) stage, improving cancer outcomes. Any screening method needs careful consideration of the psychological harms prior to implementation. The aim of this research is to explore the psychological impact of having a cancer signal detected following an MCED blood test. Methods and analysis The project is embedded in the NHS-Galleri trial (ISRCTN91431511; NCT05611632), a large clinical trial in eight Cancer Alliances in England. In the trial, over 140 000 members of the general population aged 50-77 have been randomised 1:1 to either the intervention (blood tested with MCED test) or control (blood stored) arm. The proposed project focuses on participants in the intervention arm, who have a cancer signal detected. All participants who have a cancer signal detected (expected to be around 700 assuming a 1% test positive rate) will be sent a questionnaire at three timepoints: soon after receiving their result, 6 months and approximately 12 months later. The primary outcome is anxiety, assessed using the short-form 6-item Spielberger State Trait Anxiety Inventory. We will also assess the psychological consequences of screening (using the Psychological Consequences of Screening Questionnaire), reassurance/concern about the test result, understanding of results and help/health-seeking behaviour. A subsample of 40 participants (20 with a cancer diagnosis and 20 for whom no cancer was found) will be invited to take part in a one-to-one semistructured interview. Ethics and dissemination Ethical approval for this work has been granted by the Wales Research Ethics Committee as part of the NHS-Galleri trial (Ref 21/WA/0141). Consent to be sent questionnaires is collected as part of the main trial. A separate consent form will be required for interview. Results will be disseminated via peer-reviewed publication and conference presentations.
AB - Introduction Multi-cancer early detection (MCED) blood tests look for cancer signals in cell-free deoxyribonucleic acid. These tests have the potential to detect cancers at an earlier (asymptomatic) stage, improving cancer outcomes. Any screening method needs careful consideration of the psychological harms prior to implementation. The aim of this research is to explore the psychological impact of having a cancer signal detected following an MCED blood test. Methods and analysis The project is embedded in the NHS-Galleri trial (ISRCTN91431511; NCT05611632), a large clinical trial in eight Cancer Alliances in England. In the trial, over 140 000 members of the general population aged 50-77 have been randomised 1:1 to either the intervention (blood tested with MCED test) or control (blood stored) arm. The proposed project focuses on participants in the intervention arm, who have a cancer signal detected. All participants who have a cancer signal detected (expected to be around 700 assuming a 1% test positive rate) will be sent a questionnaire at three timepoints: soon after receiving their result, 6 months and approximately 12 months later. The primary outcome is anxiety, assessed using the short-form 6-item Spielberger State Trait Anxiety Inventory. We will also assess the psychological consequences of screening (using the Psychological Consequences of Screening Questionnaire), reassurance/concern about the test result, understanding of results and help/health-seeking behaviour. A subsample of 40 participants (20 with a cancer diagnosis and 20 for whom no cancer was found) will be invited to take part in a one-to-one semistructured interview. Ethics and dissemination Ethical approval for this work has been granted by the Wales Research Ethics Committee as part of the NHS-Galleri trial (Ref 21/WA/0141). Consent to be sent questionnaires is collected as part of the main trial. A separate consent form will be required for interview. Results will be disseminated via peer-reviewed publication and conference presentations.
KW - Clinical Trial
KW - Mass Screening
KW - ONCOLOGY
KW - PREVENTIVE MEDICINE
KW - PUBLIC HEALTH
KW - QUALITATIVE RESEARCH
UR - http://www.scopus.com/inward/record.url?scp=85165435061&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-072657
DO - 10.1136/bmjopen-2023-072657
M3 - Article
C2 - 37479515
AN - SCOPUS:85165435061
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e072657
ER -
