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

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

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.

Keywords: Emotional distress; Fatigue; Group intervention; Hypnosis; Oncology.

Conflict of interest statement

Ethics approval and consent to participate

All procedures performed in this study were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

The study was approved by the Institutional Ethics Board ‘Comité d’éthique Hospitalo-Facultaire Universitaire de Liège’ (N°B707201630321), with each participant providing written consent. All modifications in the protocol will be transmitted to the Ethics Board.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Design of the study

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