Abstract

IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue (CRF), emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations (e.g., small sample size, no control group, and no follow-up). Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive trance (SICT). It seems to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions (hypnosis, meditation, and SICT) to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties (primary outcomes).Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate (hypnosis, mindful self-compassion meditation, SICT, or no intervention—control group). To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study (baseline); immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/ (NCT04873661). Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661

Highlights

  • A symptom cluster is very common among oncological patients: cancerrelated fatigue (CRF), emotional distress, sleep difficulties, pain, and cognitive difficulties

  • Investigating Self-induced cognitive trance (SICT)’s phenomenological and neurophysiological correlates, as well as its clinical applications, and comparing them with hypnosis and meditation interventions seems relevant as it will allow to better understand these non-ordinary states of consciousness and improve available complementary therapeutic options in oncology. This project’s aims are threefold: (1) Evaluating the short- and long-term clinical benefits of hypnosis, meditation, and SICT in terms of CRF, emotional distress, sleep difficulties, and pain, as well as other psychological variables in patients with cancer; (2) Measuring the evolution of (a) phenomenological and (b) neurobiological correlates of hypnosis, meditation, and SICT in these patients, to better understand the effects of these interventions; (3) Confirming the biopsychosocial model of hypnosis and investigating whether meditation and SICT responsiveness are mediated by the same mechanisms as hypnosis

  • We designed a longitudinal controlled superiority trial with 160 patients with cancer who will choose between four conditions: hypnosis-based group intervention, mindful self-compassion (MSC) meditation-based group intervention, SICT-based group intervention, or a control group

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Summary

Introduction

A symptom cluster is very common among oncological patients: cancerrelated fatigue (CRF), emotional distress, sleep difficulties, pain, and cognitive difficulties. Emotional distress, endured by a large proportion of patients with cancer as well (Mehnert et al, 2018; Götze et al, 2020), can be defined as “a multifactorial, unpleasant experience of a psychologic (i.e., cognitive, behavioral, and emotional), social, spiritual, and/or physical nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment” (Mitchell et al, 2011; Riba et al, 2019) It negatively influences treatment adherence (Lin et al, 2017) and results (Batty et al, 2017), as well as patient’s general quality of life (Achimas-Cadariu et al, 2015; Riba et al, 2019). Cancer-related pain is reported by more than 50% of patients, which severely impacts quality of life, Abbreviations: ANOVA, Analysis of variance; BFI, Big Five Inventory; CERQ, Cognitive Emotion Regulation Questionnaire; CEQ, Creative Experiences Questionnaire; CHU, “Centre hospitalier universitaire” (University Hospital); CRF, Cancer-related fatigue; ECG, Electrocardiogram; EEG, Electroencephalogram; EMG, Electromyogram; FACT-Cog, Functional Assessment of Cancer Therapy - Cognitive Function; GDPR, General Data Protection Regulation; HADS, Hospital Anxiety and Depression Scale; Hrs, hours; ISI, Insomnia Severity Index; MAC, Mental adjustment to cancer; MCQ, Memory Characteristics Questionnaire; MEQ, Mystical Experience Questionnaire; MFI, Multidimensional fatigue inventory; MPFI, Multidimensional Psychological Flexibility Index; MSC, Mindful self-compassion; SICT, Self-induced cognitive trance; VAS, Visual analogue scale

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