Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct
Introduction Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with c...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e056973.full |
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| author | Dirk Schadendorf Peter Martus Stephan Zipfel Yesim Erim Alexander Bäuerle Martin Teufel Caterina Schug Johanna Graf Wolfgang Bethge Andreas Dinkel Anja Neumann Jasmin Steinbach Jana Heinen Julia Barbara Krakowczyk Mirjam Damerau Sebastian Dries Anja Mehnert-Theuerkauf Mitra Tewes Jörg Wiltink Alexander Wünsch |
| author_facet | Dirk Schadendorf Peter Martus Stephan Zipfel Yesim Erim Alexander Bäuerle Martin Teufel Caterina Schug Johanna Graf Wolfgang Bethge Andreas Dinkel Anja Neumann Jasmin Steinbach Jana Heinen Julia Barbara Krakowczyk Mirjam Damerau Sebastian Dries Anja Mehnert-Theuerkauf Mitra Tewes Jörg Wiltink Alexander Wünsch |
| author_sort | Dirk Schadendorf |
| collection | DOAJ |
| description | Introduction Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint).Methods and analysis The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18–65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate.Ethics and dissemination The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations.Trial registration number German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213. |
| format | Article |
| id | doaj-art-6bffb670f21544b1aa12d6c7fd496e80 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-6bffb670f21544b1aa12d6c7fd496e802025-01-24T15:20:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-056973Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial ReductDirk Schadendorf0Peter Martus1Stephan Zipfel2Yesim Erim3Alexander Bäuerle4Martin Teufel5Caterina Schug6Johanna Graf7Wolfgang Bethge8Andreas Dinkel9Anja Neumann10Jasmin Steinbach11Jana Heinen12Julia Barbara Krakowczyk13Mirjam Damerau14Sebastian Dries15Anja Mehnert-Theuerkauf16Mitra Tewes17Jörg Wiltink18Alexander Wünsch19Comprehensive Cancer Center (CCC), University Hospital Essen, Essen, GermanyInstitute for Clinical Epidemiology and Biometry, Eberhard Karls University Tübingen Faculty of Medicine, Tubingen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, Eberhard Karls University, University Hospital Tübingen, Tübingen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, Friedrich-Alexander-University Erlangen-Nürnberg, University Hospital Erlangen, Erlangen, GermanyClinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany1 Department for Psychosomatic Medicine and Psychotherapy, LVR-University Hospital Essen, University of Duisburg-Essen, Essen, Nordrhein-Westfalen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, GermanyPsychosomatic Medicine and Psychotherapy, Medical University Hospital Tübingen, Tübingen, GermanyCentre of Clinical Trials (ZKS) Tübingen, Eberhard Karls University Tübingen, University Hospital Tübingen, Tübingen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, School of Medicine, Technical University of Munich, München, GermanyInstitute for Medicine Management, University of Duisburg-Essen, Duisburg, GermanyClinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, Eberhard Karls University, University Hospital Tübingen, Tübingen, GermanyClinic for Psychosomatic Medicine and Psychotherapy, LVR-University Hospital, University of Duisburg-Essen, Essen, GermanyClinic for Psychosomatic Medicine and Psychotherapy, LVR-University Hospital, University of Duisburg-Essen, Essen, GermanyHealthcare Department, Fraunhofer Institute for Software and Systems Engineering (ISST), Dortmund, GermanyDepartment of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Leipzig, GermanyComprehensive Cancer Center (CCC), University Hospital Essen, Essen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, GermanyFreiburg university Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Freiburg, GermanyIntroduction Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint).Methods and analysis The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18–65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate.Ethics and dissemination The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations.Trial registration number German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.https://bmjopen.bmj.com/content/12/6/e056973.full |
| spellingShingle | Dirk Schadendorf Peter Martus Stephan Zipfel Yesim Erim Alexander Bäuerle Martin Teufel Caterina Schug Johanna Graf Wolfgang Bethge Andreas Dinkel Anja Neumann Jasmin Steinbach Jana Heinen Julia Barbara Krakowczyk Mirjam Damerau Sebastian Dries Anja Mehnert-Theuerkauf Mitra Tewes Jörg Wiltink Alexander Wünsch Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct BMJ Open |
| title | Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct |
| title_full | Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct |
| title_fullStr | Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct |
| title_full_unstemmed | Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct |
| title_short | Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct |
| title_sort | web based mindfulness and skills based distress reduction for patients with cancer study protocol of the multicentre randomised controlled confirmatory intervention trial reduct |
| url | https://bmjopen.bmj.com/content/12/6/e056973.full |
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