Hypnosis group interventionCognitive trance group interventionMeditation group intervention
Hypnosis group intervention: See arm description
Cognitive trance group intervention: See arm description
Meditation group intervention: See arm description
Study summary
Patients with cancer often suffer from a symptom cluster, including pain, fatigue, sleep difficulties, emotional distress and cognitive impairments. In oncology settings, there is a growing interest in "mind-body" intervention, to relieve them in a non-pharmacological way. Hypnosis and meditation are two modified state of consciousness shown to positively this symptom cluster. Cognitive trance is also a modified state of consciousness, but is induced by body movements and/or vocalizations. Subjective reports of experts in cognitive trance showed a modification of self, emotion regulation, pain perception, attention and concentration. However, we still need to develop studies to better characterise this particular state of consciousness and its clinical applications. Our randomized-controlled trial aims at comparing both interventions in terms of (1) benefits on cancer patients' quality of life (pain, fatigue, sleep, distress, cognitive impairments), (2) phenomenological/subjective experiences and neurophysiological correlates, and (3) mechanisms involved in patients' responsiveness, based on the biopsychosocial model of hypnosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥18 years old
* No neurological/psychiatric disorders/history of alcohol or drug abuse
* No current and regular practice of hypnosis, meditation or cognitive trance
* Diagnosis of cancer (all localisations accepted except brain tumours to avoid any effect on EEG data and cognitive impairments)
* Active treatments (surgery, chemotherapy, radiotherapy) finished for less than a year.
* Score of at least 4/10 for one of these four symptoms at baseline: pain, fatigue, sleep difficulties, emotional distress.
Exclusion Criteria:
* \< 18 year old
* No cancer diagnosis
* Neurological or psychiatric disorder
* Brain tumour ou other tumour with brain metastases
* Active treatments still ongoing or finished for more than a year
* No baseline symptom at 4/10
Primary outcome measure(s)
Change in Fatigue — Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4) Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)
Change in Pain — Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4) Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain)
Change in Sleep difficulties — Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4) Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher sleep difficulties.
Change in Emotional distress — Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4) Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher emotional distress
Change in Perceived cognitive difficulties — Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4) Assessed with a questionnaire (FACT-Cog), investigation 4 dimensions (perceived cognitive impairments, score range 0-72, higher score indicating less impairments ; impact of cognitive impairments on quality of life, score range 0-16, with higher scoe indicating less impact ; Comments from others, score range 0-16 with higher score indicating less comments ; perceived cognitive abilities, score range 0-28, with higher score indicating more cognitive abilities)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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