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NCT Number: NCT04873661

Cognitive Trance, Hypnosis and Meditation in Oncology

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Cognition Disorders Cognitive Dysfunction Cognitive Impairment Distress, Emotional Fatigue Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis group intervention

Behavioral

See arm description

Cognitive trance group intervention

Behavioral

See arm description

Meditation group intervention

Behavioral

See arm description

Primary outcomes

  1. Change in Fatigue

    Time frame: 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)

  2. Change in Pain

    Time frame: 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)

  3. Change in Sleep difficulties

    Time frame: 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.

  4. Change in Emotional distress

    Time frame: 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

  5. Change in Perceived cognitive difficulties

    Time frame: 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)

Secondary outcomes

  1. Change in Psychological flexibility

    Time frame: 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 Psychological Flexibility Inventory; MPFI-24). Score range from 0 to 6 for each dimension (psychological flexibility and psychological inflexibility), with higher score indicating higher flexibility or inflexibility according to the dimension assessed.

  2. Change in Mental Adjustment to Cancer

    Time frame: 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 (Mental adjustment to cancer; MAC). 2 summary scores (Summary positive adjustment, score range from 17 to 68, with higher score indicating higher positive adjustmen ; Summary Negative Adjustment, score ranging from 16 to 64, with higher score indicating highr negative adjustment)

  3. Change in Emotion regulation

    Time frame: 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 (Cognitive Emotion Regulation Questionnaire; CERQ). 2 summary scores (adpative regulation, score ranging from 20 to 100, with higher score indicating higher adaptive regulation ; non-adaptive regulation, score ranging 12-60, with higher score indicating higher non-adaptive regulation)

  4. Change in Empowerment

    Time frame: 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 composed of 7 VAS (score from 0 to 10/10, with higher score indicating higher empowerment), based on the Health Education Impact Questionnaire (heiQ)

  5. Personnality characteristics

    Time frame: Assessed before the intervention (T0)

    Assessed with a questionnaire (Big Five Short Form; BFI-10). 5 scales (extraversion, agreeableness, conscientiousness, neuroticism, openness to experience) with score range 1-5, with higher score indicating a stronger presence of this personality trait.

  6. Fantasy Proneness (imaginative experiences)

    Time frame: Assessed before the intervention (T0)

    Assessed with a questionnaire designed by our team investigating the previous imaginative experiences of the participant. 25 true/false items. Total score ranging from 0 to 25, with higher score indicating higher level of fantasy proneness.

  7. Expectations and motivation to participate in the chosen intervention

    Time frame: Assessed before the intervention (T0)

    Assessed with 2 VAS (score range from 0 to 10/10, with higher score indicating higher motivation and higher expectations)

  8. Personal definition of hypnosis/cognitive trance/meditation

    Time frame: Assessed before the intervention (T0)

    Free text written by the participant

  9. Change in the characteristics of a free recall of an intense hypnosis/cognitive trance/meditation episode (or an intense autobiographical episode for the participants in the control group)

    Time frame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

    Free text written by the participant

  10. Change in Characteristics of the intense memory described above

    Time frame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

    Assessed with a questionnaire (Memory Characteristics Questionnaire; MCQ). Score range from 8 to 104, with higher score indicating higher degree of details about the memory.

  11. Change in Mystical characteristics of the intense memory described above

    Time frame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

    Assessed with a questionnaire (Revised Mystical Characteristics Questionnaire; MEQ-30). 4 scales (mystical, score range 0-75, with higher score indicating a more mystical experience ; Positive mood, score range 0-30, with higher score indicating more positive mood during the episode ; Transcendence of time and space, score range 0-30, with higher score indicating stronger trenscendence ; Ineffability, score range 0-15, with higher score indicating higher ineffability)

  12. Change in presence during the intense memory described above

    Time frame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

    Assessed with a questionnaire designed by our team to assess the feeling of presence in the imaginative environment linked to the intense memory reported (hypnosis, trance, meditation or personal memory). 2 scales (Presence in the suggested environment and Interaction with others, score range for each dimension 6-42, with higher score indicating higer presence/interaction).

  13. Change in the quality of the relationship with the therapist who animated the group sessions

    Time frame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)

    Assessed with a VAS (score range from 0 to 10/10, with higher score indicating better relationship quality).

  14. Change in cerebral activity

    Time frame: Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.

    Assessed with an electroencephalogram (EEG), during resting state and during hypnosis, trance or meditation, according to the chosen intervention. During the EEG, we will also measure the heart rate (with an electrocardiogram), the body temperature, the body movements (with an electromyogram) and the respiration amplitude.

  15. Change in heart rate

    Time frame: Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.

    During the EEG, heart rate will be measured (with an electrocardiogram).

  16. Change in body movements

    Time frame: Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.

    During the EEG, body movements will be measured (with an electromyogram).

  17. Change in body temperature

    Time frame: Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.

    During the EEG, body temperature will be measured (with a dedicated electrode put on the chest).

  18. Change in respiration

    Time frame: Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.

    During the EEG, respiration (amplitude, effort) will be measured (with a dedicated belts put on the torso)

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • Bial Foundation
  • Centre Hospitalier Universitaire de Liege
  • FNRS (Télévie)
  • Fondation contre le cancer

Registry information

Official study title

Hypnosis, Meditation and Cognitive Trance on Cancer Patients: Impact on Quality of Life and Neurophysiology

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 5, 2021
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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