What is the impact of targeted therapies given within phase I trials on the cognitive function of patients with advanced cancer: a mixed-methods exploratory study conducted in an early clinical trials unit
What is the impact of targeted therapies given within phase I trials on the cognitive function of patients with advanced cancer: a mixed-methods exploratory study conducted in an early clinical trials unit
Introduction Novel therapies such as small protein molecule inhibitors and immunotherapies are tested in early phase trials before moving to later phase trials and ultimately standard practice. A key aim of these clinical trials is to define a toxicity profile, however, the emphasis is often on safety with measurements of organ toxicity. Other subjective side effects can be under-reported because they are not measured formally within the trial protocols. The concern from clinical practice is that cognitive toxicity is poorly studied and may be under-reported in this context. This could lead to toxicity profiles of new treatments not being fully described and patients with unmet need in terms of acknowledgement and support of symptoms. This protocol outlines a framework of an exploratory study with feasibility aspects to investigate the impact and experience of cognitive changes for patients on phase I trials. Methods and analysis This is a mixed-methods study, combining quantitative and qualitative approaches. The sample is 30 patients with advanced cancer who are participating in phase I trials of novel therapies in the early clinical trials unit of a specialist cancer centre. A test battery of validated cognitive assessments will be taken alongside patient reported outcome measures at three time points from baseline, day eight and day 28 post start of treatment. At day 28, a semi-structured interview will be conducted and the narrative thematically analysed. Results will be integrated to offer a comprehensive description of cognitive function in this patient group. Ethics and dissemination The study has received full HRA and ethical approval. It is the first study to introduce formal cognitive assessments in a cancer phase I trial context. The study has the potential to highlight previously unreported side effects and more importantly unmet need in terms of care for patients who are participating in the trials.
adult oncology, clinical pharmacology, clinical trials, delirium & cognitive disorders
Stapleton, Sarah
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Darlington, Anne-sophie Emma
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De Bono, J.S.
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Wiseman, Theresa
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Stapleton, Sarah
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Darlington, Anne-sophie Emma
472fcfc9-160b-4344-8113-8dd8760ff962
De Bono, J.S.
a8903092-bd5f-44d6-bc86-e6c173400829
Wiseman, Theresa
e3ff42ae-97ef-4640-af3d-40eeae830df9
Stapleton, Sarah, Darlington, Anne-sophie Emma, De Bono, J.S. and Wiseman, Theresa
(2022)
What is the impact of targeted therapies given within phase I trials on the cognitive function of patients with advanced cancer: a mixed-methods exploratory study conducted in an early clinical trials unit.
BMJ Open, 12 (11), [e050590].
(doi:10.1136/bmjopen-2021-050590).
Abstract
Introduction Novel therapies such as small protein molecule inhibitors and immunotherapies are tested in early phase trials before moving to later phase trials and ultimately standard practice. A key aim of these clinical trials is to define a toxicity profile, however, the emphasis is often on safety with measurements of organ toxicity. Other subjective side effects can be under-reported because they are not measured formally within the trial protocols. The concern from clinical practice is that cognitive toxicity is poorly studied and may be under-reported in this context. This could lead to toxicity profiles of new treatments not being fully described and patients with unmet need in terms of acknowledgement and support of symptoms. This protocol outlines a framework of an exploratory study with feasibility aspects to investigate the impact and experience of cognitive changes for patients on phase I trials. Methods and analysis This is a mixed-methods study, combining quantitative and qualitative approaches. The sample is 30 patients with advanced cancer who are participating in phase I trials of novel therapies in the early clinical trials unit of a specialist cancer centre. A test battery of validated cognitive assessments will be taken alongside patient reported outcome measures at three time points from baseline, day eight and day 28 post start of treatment. At day 28, a semi-structured interview will be conducted and the narrative thematically analysed. Results will be integrated to offer a comprehensive description of cognitive function in this patient group. Ethics and dissemination The study has received full HRA and ethical approval. It is the first study to introduce formal cognitive assessments in a cancer phase I trial context. The study has the potential to highlight previously unreported side effects and more importantly unmet need in terms of care for patients who are participating in the trials.
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e050590.full
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Accepted/In Press date: 31 July 2022
e-pub ahead of print date: 28 November 2022
Additional Information:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Keywords:
adult oncology, clinical pharmacology, clinical trials, delirium & cognitive disorders
Identifiers
Local EPrints ID: 473230
URI: http://eprints.soton.ac.uk/id/eprint/473230
ISSN: 2044-6055
PURE UUID: 95e7dbb0-a733-479d-89e6-f641182994f5
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Date deposited: 12 Jan 2023 18:07
Last modified: 16 Mar 2024 23:30
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Author:
Sarah Stapleton
Author:
J.S. De Bono
Author:
Theresa Wiseman
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