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    EPIC: an evaluation of the psychological impact of early-phase clinical trials in cancer patients

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    Authors
    Jittla, P.
    Graham, Donna
    Zhou, Cong
    Halliwell, J.
    O'Reilly, S.
    Aruketty, Sreeja
    Azizi, Alexander
    Germetaki, Theodora
    Lowe, Jessica
    Little, Martin
    Punnett, Grant
    McMahon, P.
    Benson, L.
    Carter, Louise
    Krebs, Matthew G
    Thistlethwaite, Fiona C
    Darlington, E.
    Yorke, Janelle
    Cook, Natalie
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    Affiliation
    Experimental Cancer Medicine Team, The Christie NHS Foundation Trust, Manchester, UK
    Issue Date
    2022
    
    Metadata
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    Abstract
    Background: Anxiety and depression in patients with cancer is associated with decreased quality of life and increased morbidity and mortality. However, these are often overlooked and untreated. Early-phase clinical trials (EPCTs) recruit patients with advanced cancers who frequently lack future treatment options, which may lead to increased anxiety and depression. Despite this, EPCTs do not routinely consider psychological screening for patients. Patients and methods: This prospective observational study explored levels of anxiety and depression alongside impact of trial participation in the context of EPCTs. The Hospital Anxiety and Depression Scale and the Brief Illness Perceptions Questionnaire were completed at the point of EPCT consent, the end of screening and at pre-specified time points thereafter. Results: Sixty-four patients (median age 56 years; median Eastern Cooperative Oncology Group performance status 1) were recruited. At consent, 57 patients returned questionnaires; 39% reported clinically relevant levels of anxiety whilst 18% reported clinically relevant levels of depression. Sixty-three percent of patients experiencing psychological distress had never previously reported this. Males were more likely to be depressed (P = 0.037) and females were more likely to be anxious (P = 0.011). Changes in anxiety or depression were observed after trial enrolment on an individual level, but not significant on a population level. Conclusions: Patients on EPCTs are at an increased risk of anxiety and depression but may not seek relevant support. Sites offering EPCTs should consider including psychological screening to encourage a more holistic approach to cancer care and consider the sex of individuals when tailoring psychological support to meet specific needs.
    Citation
    Jittla P, Graham DM, Zhou C, Halliwell J, O'Reilly S, Aruketty S, et al. EPIC: an evaluation of the psychological impact of early-phase clinical trials in cancer patients. ESMO open. 2022 Aug 19;7(5):100550. PubMed PMID: 35994790. Epub 2022/08/23. eng.
    Journal
    ESMO Open
    URI
    http://hdl.handle.net/10541/625584
    DOI
    10.1016/j.esmoop.2022.100550
    PubMed ID
    35994790
    Additional Links
    https://dx.doi.org/10.1016/j.esmoop.2022.100550
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.esmoop.2022.100550
    Scopus Count
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