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Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Study protocol

Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol

Authors: Charlotte Grégoire, Marie-Elisabeth Faymonville, Audrey Vanhaudenhuyse, Vanessa Charland-Verville, Guy Jerusalem, Isabelle Bragard

Published in: BMC Cancer | Issue 1/2018

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Abstract

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.
Appendix
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Metadata
Title
Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol
Authors
Charlotte Grégoire
Marie-Elisabeth Faymonville
Audrey Vanhaudenhuyse
Vanessa Charland-Verville
Guy Jerusalem
Isabelle Bragard
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-5046-6

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