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Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol
BACKGROUND: Cancer has a lot of consequences on patients’ quality of life (such as cancer-related fatigue (CRF), sleep difficulties and emotional distress) and on patients’ partners and their relationship, such as distress and communication difficulties. These consequences are undertreated, and inte...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6238378/ https://www.ncbi.nlm.nih.gov/pubmed/30442120 http://dx.doi.org/10.1186/s12885-018-5046-6 |
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author | Grégoire, Charlotte Faymonville, Marie-Elisabeth Vanhaudenhuyse, Audrey Charland-Verville, Vanessa Jerusalem, Guy Bragard, Isabelle |
author_facet | Grégoire, Charlotte Faymonville, Marie-Elisabeth Vanhaudenhuyse, Audrey Charland-Verville, Vanessa Jerusalem, Guy Bragard, Isabelle |
author_sort | Grégoire, Charlotte |
collection | PubMed |
description | BACKGROUND: Cancer has a lot of consequences on patients’ quality of life (such as cancer-related fatigue (CRF), sleep difficulties and emotional distress) and on patients’ partners and their relationship, such as distress and communication difficulties. These consequences are undertreated, and interventions based on hypnosis often focus on breast cancer patients only. This paper describes the study protocol of a longitudinal randomized controlled trial aiming to assess the efficacy of an 8-week intervention combining hypnosis and self-care to improve cancer patients’ CRF, sleep and emotional distress and to indirectly improve their partners’ distress. METHODS: A power analysis required a total sample of 88 patients. To test the efficacy of the intervention, results of the experimental group receiving the intervention will be compared to those of the control group. Data will be collected by questionnaires, relaxation tasks, an attentional bias task, and everyday life assessments measured at four different times: 1.) before inclusion in the study (baseline); 2.) after the intervention; and 3.) at 4- and 12-month follow-up. Partners’ symptoms will also be evaluated with questionnaires at the same measurement times. DISCUSSION: There is a growing interest in alternative approaches (such as hypnosis) in addition to standard therapies in oncology settings. The results of this study should be useful for improving knowledge about long-term efficacy of hypnosis-based group interventions for CRF, sleep and distress among all types of cancer patients and their partners, and to better understand the mechanisms of emotional regulation in cancer patients through the attentional bias task. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12885-018-5046-6) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6238378 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-62383782018-11-26 Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol Grégoire, Charlotte Faymonville, Marie-Elisabeth Vanhaudenhuyse, Audrey Charland-Verville, Vanessa Jerusalem, Guy Bragard, Isabelle BMC Cancer Study Protocol BACKGROUND: Cancer has a lot of consequences on patients’ quality of life (such as cancer-related fatigue (CRF), sleep difficulties and emotional distress) and on patients’ partners and their relationship, such as distress and communication difficulties. These consequences are undertreated, and interventions based on hypnosis often focus on breast cancer patients only. This paper describes the study protocol of a longitudinal randomized controlled trial aiming to assess the efficacy of an 8-week intervention combining hypnosis and self-care to improve cancer patients’ CRF, sleep and emotional distress and to indirectly improve their partners’ distress. METHODS: A power analysis required a total sample of 88 patients. To test the efficacy of the intervention, results of the experimental group receiving the intervention will be compared to those of the control group. Data will be collected by questionnaires, relaxation tasks, an attentional bias task, and everyday life assessments measured at four different times: 1.) before inclusion in the study (baseline); 2.) after the intervention; and 3.) at 4- and 12-month follow-up. Partners’ symptoms will also be evaluated with questionnaires at the same measurement times. DISCUSSION: There is a growing interest in alternative approaches (such as hypnosis) in addition to standard therapies in oncology settings. The results of this study should be useful for improving knowledge about long-term efficacy of hypnosis-based group interventions for CRF, sleep and distress among all types of cancer patients and their partners, and to better understand the mechanisms of emotional regulation in cancer patients through the attentional bias task. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12885-018-5046-6) contains supplementary material, which is available to authorized users. BioMed Central 2018-11-15 /pmc/articles/PMC6238378/ /pubmed/30442120 http://dx.doi.org/10.1186/s12885-018-5046-6 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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. |
spellingShingle | Study Protocol Grégoire, Charlotte Faymonville, Marie-Elisabeth Vanhaudenhuyse, Audrey Charland-Verville, Vanessa Jerusalem, Guy Bragard, Isabelle Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol |
title | Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol |
title_full | Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol |
title_fullStr | Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol |
title_full_unstemmed | Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol |
title_short | Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol |
title_sort | randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6238378/ https://www.ncbi.nlm.nih.gov/pubmed/30442120 http://dx.doi.org/10.1186/s12885-018-5046-6 |
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