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      A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial

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          Abstract

          Background

          Mindfulness has been applied to improve cancer care by enhancing psychological well-being. However, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening functional brain connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast cancer patients after chemotherapy.

          Methods/design

          The present study is a three-arm, parallel-group, randomized controlled trial with assessments at baseline, 1 to 3 weeks after the intervention and at 3 months’ follow-up. One hundred and twenty breast cancer patients who ended treatment a minimum of 6 months and a maximum of 5 years before, and who have cognitive complaints, will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group ( n = 40), (2) an active control condition based on physical training ( n = 40), or (3) a treatment as usual (TAU) control group ( n = 40). Both the mindfulness-based intervention and the active control condition consist of four group sessions (3 h for the mindfulness condition and 2 h for the physical training) spread over 8 weeks. The primary outcomes will be cognitive symptoms as measured by the Cognitive Failure Questionnaire and changes in functional brain connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness, quality of life; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging and (4) measures of inflammation.

          Discussion

          The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.

          Trial registration

          ClinicalTrials.gov, ID: NCT03736460. Retrospectively registered on 8 November 2018.

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          Most cited references26

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          Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing

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            The neuroscience of mindfulness meditation.

            Research over the past two decades broadly supports the claim that mindfulness meditation - practiced widely for the reduction of stress and promotion of health - exerts beneficial effects on physical and mental health, and cognitive performance. Recent neuroimaging studies have begun to uncover the brain areas and networks that mediate these positive effects. However, the underlying neural mechanisms remain unclear, and it is apparent that more methodologically rigorous studies are required if we are to gain a full understanding of the neuronal and molecular bases of the changes in the brain that accompany mindfulness meditation.
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              Conceptualizing and testing random indirect effects and moderated mediation in multilevel models: new procedures and recommendations.

              The authors propose new procedures for evaluating direct, indirect, and total effects in multilevel models when all relevant variables are measured at Level 1 and all effects are random. Formulas are provided for the mean and variance of the indirect and total effects and for the sampling variances of the average indirect and total effects. Simulations show that the estimates are unbiased under most conditions. Confidence intervals based on a normal approximation or a simulated sampling distribution perform well when the random effects are normally distributed but less so when they are nonnormally distributed. These methods are further developed to address hypotheses of moderated mediation in the multilevel context. An example demonstrates the feasibility and usefulness of the proposed methods.
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                Author and article information

                Contributors
                Katleen.vandergucht@kuleuven.be
                Michelle.melis@kuleuven.be
                Soumaya.ahmadoun@kuleuven.be
                Anneleen.gebruers@uzleuven.be
                Ann.smeets@uzleuven.be
                Mathieu.vandenbulcke@uzleuven.be
                Hans.wildiers@uzleuven.be
                Patrick.neven@uzleuven.be
                Peter.kuppens@kuleuven.be
                Filip.raes@kuleuven.be
                Stefan.sunaert@kuleuven.be
                Sabine.deprez@kuleuven.be
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                23 March 2020
                23 March 2020
                2020
                : 21
                : 290
                Affiliations
                [1 ]GRID grid.5596.f, ISNI 0000 0001 0668 7884, Leuven Mindfulness Centre, Faculty of Psychology and Educational Sciences, , University of Leuven, ; Tiensestraat 102, 3000 Leuven, Belgium
                [2 ]GRID grid.5596.f, ISNI 0000 0001 0668 7884, Department of Imaging and Pathology, , KU Leuven, ; Herestraat 49, 3000 Leuven, Belgium
                [3 ]GRID grid.410569.f, ISNI 0000 0004 0626 3338, Multidisciplinary Breast Centre, , University Hospitals Leuven, ; Herestraat 49, 3000 Leuven, Belgium
                [4 ]GRID grid.5596.f, ISNI 0000 0001 0668 7884, Department of Oncology, , KU Leuven, ; Leuven, Belgium
                [5 ]GRID grid.410569.f, ISNI 0000 0004 0626 3338, Department of Surgical Oncology, , University Hospitals Leuven, ; Herestraat 49, 3000 Leuven, Belgium
                [6 ]GRID grid.5596.f, ISNI 0000 0001 0668 7884, Department of Neurosciences, , KU Leuven, ; Leuven, Belgium
                [7 ]GRID grid.410569.f, ISNI 0000 0004 0626 3338, Department of Psychiatry, , University Hospitals Leuven, ; Herestraat 49, 3000 Leuven, Belgium
                [8 ]GRID grid.410569.f, ISNI 0000 0004 0626 3338, Department of General Medical Oncology, , University Hospitals Leuven, ; Herestraat 49, 3000 Leuven, Belgium
                [9 ]GRID grid.410569.f, ISNI 0000 0004 0626 3338, Department of Gynaecology and Obstetrics, , University Hospitals Leuven, ; Herestraat 49, 3000 Leuven, Belgium
                [10 ]GRID grid.410569.f, ISNI 0000 0004 0626 3338, Department of Radiology, , University Hospitals Leuven, ; Herestraat 49, 3000 Leuven, Belgium
                Author information
                http://orcid.org/0000-0003-0206-4131
                Article
                4204
                10.1186/s13063-020-4204-8
                7092531
                9a7a5006-476e-46a4-9cac-c677c524668f
                © The Author(s). 2020

                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/. The Creative Commons Public Domain Dedication waiver ( http://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.

                History
                : 1 February 2019
                : 24 February 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100011851, Kom op tegen Kanker;
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2020

                Medicine
                cognitive impairment,breast cancer,mindfulness,randomized controlled trial,brain imaging
                Medicine
                cognitive impairment, breast cancer, mindfulness, randomized controlled trial, brain imaging

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