Cognitive Trance, Hypnosis and Meditation in Oncology

NCT04873661 | Active Not Recruiting

• 1 other identifier: Trance-Onco
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Distress, Emotional; Pain; Fatigue; Sleep Disturbance; Cognitive Impairment

Keywords

Hypnosis; Cognitive trance; Meditation; Cancer; Oncology; Quality of life; Neurophysiology; Phenomenology

Outcome Measures

Primary Outcomes (5)

• Change in Fatigue

  Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Change in Pain

  Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain)

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Change in Sleep difficulties

  Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher sleep difficulties.

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Change in Emotional distress

  Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher emotional distress

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Change in Perceived cognitive difficulties

  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)

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

Secondary Outcomes (18)

• Change in Psychological flexibility

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Change in Mental Adjustment to Cancer

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Change in Emotion regulation

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Change in Empowerment

  Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

• Personnality characteristics

  Assessed before the intervention (T0)

Study Arms (4)

Hypnosis

EXPERIMENTAL

In the hypnosis-based intervention, patients (in groups of approximately 10 participants) will participate in 8 weekly sessions (2 hours each) during which they will benefit from guided hypnosis exercises, and learn how to implement self-hypnosis. They will also receive a CD with hypnosis exercises for home practice. At-home practice is encouraged between sessions.

Behavioral: Hypnosis group intervention

Cognitive trance

EXPERIMENTAL

The cognitive trance-based intervention will consist of a two-day workshop in groups of approximately 10 participants, where they will learn how to induce the cognitive trance, with the use of different sound-loops that can induce trance in untrained people in a safe way. After two weeks of home practice, participants will redo a two-day consolidation training. At-home practice is encouraged between sessions.

Behavioral: Cognitive trance group intervention

Meditation

EXPERIMENTAL

The meditation-based intervention will consist of 8 weekly sessions (2h45 each) in groups of approximately 10 participants, as well as half a day of intensive practice between the fifth and the sixth session. Participants will learn how to implement self-compassion meditation, through practical exercises proposed during the sessions. At-home practice is encouraged between sessions.

Behavioral: Meditation group intervention

Control group

NO INTERVENTION

Participants in the control group will not receive any intervention during the whole duration of the study. They will be assessed at the same times and in the same ways than the 3 experimental groups. After the study, they will have the opportunity to participe in one of the 3 interventions if they want to.

Interventions

Hypnosis group intervention BEHAVIORAL

See arm description

Hypnosis

Cognitive trance group intervention BEHAVIORAL

See arm description

Cognitive trance

Meditation group intervention BEHAVIORAL

See arm description

Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Liege: lead
• FNRS (Télévie): collaborator
• Fondation contre le cancer: collaborator
• Bial Foundation: collaborator
• Centre Hospitalier Universitaire de Liege: collaborator

Study Sites (1)

University of Liège

Liège, 4000, Belgium

Location

Related Publications (2)

• Baussard L, Ernst M, Diep A, Jerusalem G, Vanhaudenhuyse A, Marie N, Bragard I, Faymonville ME, Gosseries O, Gregoire C. Network Analyses Applied to the Dimensions of Cancer-Related Fatigue in Women With Breast Cancer. Cancer Med. 2024 Oct;13(19):e70268. doi: 10.1002/cam4.70268.

  PMID: 39387227 DERIVED

• Gregoire C, Marie N, Sombrun C, Faymonville ME, Kotsou I, van Nitsen V, de Ribaucourt S, Jerusalem G, Laureys S, Vanhaudenhuyse A, Gosseries O. Hypnosis, Meditation, and Self-Induced Cognitive Trance to Improve Post-treatment Oncological Patients' Quality of Life: Study Protocol. Front Psychol. 2022 Feb 10;13:807741. doi: 10.3389/fpsyg.2022.807741. eCollection 2022.

  PMID: 35222195 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain; Fatigue; Parasomnias; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Olivia Gosseries, PhD

  ULiège

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Medical Sciences

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 5, 2021
• Study Start: January 1, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)