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Cognitive Trance, Hypnosis and Meditation in Oncology

Primary Purpose

Cancer, Distress, Emotional, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hypnosis group intervention
Cognitive trance group intervention
Meditation group intervention
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Hypnosis, Cognitive trance, Meditation, Cancer, Oncology, Quality of life, Neurophysiology, Phenomenology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of LiègeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Hypnosis

Cognitive trance

Meditation

Control group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Fatigue
Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)
Change in Pain
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 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 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 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 Outcome Measures

Change in Psychological flexibility
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.
Change in Mental Adjustment to Cancer
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)
Change in Emotion regulation
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)
Change in Empowerment
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)
Personnality characteristics
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.
Fantasy Proneness (imaginative experiences)
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.
Expectations and motivation to participate in the chosen intervention
Assessed with 2 VAS (score range from 0 to 10/10, with higher score indicating higher motivation and higher expectations)
Personal definition of hypnosis/cognitive trance/meditation
Free text written by the participant
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)
Free text written by the participant
Change in Characteristics of the intense memory described above
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.
Change in Mystical characteristics of the intense memory described above
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)
Change in presence during the intense memory described above
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).
Change in the quality of the relationship with the therapist who animated the group sessions
Assessed with a VAS (score range from 0 to 10/10, with higher score indicating better relationship quality).
Change in cerebral activity
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.
Change in heart rate
During the EEG, heart rate will be measured (with an electrocardiogram).
Change in body movements
During the EEG, body movements will be measured (with an electromyogram).
Change in body temperature
During the EEG, body temperature will be measured (with a dedicated electrode put on the chest).
Change in respiration
During the EEG, respiration (amplitude, effort) will be measured (with a dedicated belts put on the torso)

Full Information

First Posted
April 26, 2021
Last Updated
February 9, 2023
Sponsor
University of Liege
Collaborators
FNRS (Télévie), Fondation contre le cancer, Bial Foundation, Centre Hospitalier Universitaire de Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04873661
Brief Title
Cognitive Trance, Hypnosis and Meditation in Oncology
Official Title
Hypnosis, Meditation and Cognitive Trance on Cancer Patients: Impact on Quality of Life and Neurophysiology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
FNRS (Télévie), Fondation contre le cancer, Bial Foundation, Centre Hospitalier Universitaire de Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Distress, Emotional, Pain, Fatigue, Sleep Disturbance, Cognitive Impairment
Keywords
Hypnosis, Cognitive trance, Meditation, Cancer, Oncology, Quality of life, Neurophysiology, Phenomenology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive trance
Arm Type
Experimental
Arm Description
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.
Arm Title
Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis group intervention
Intervention Description
See arm description
Intervention Type
Behavioral
Intervention Name(s)
Cognitive trance group intervention
Intervention Description
See arm description
Intervention Type
Behavioral
Intervention Name(s)
Meditation group intervention
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Change in Fatigue
Description
Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)
Time Frame
Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in Pain
Description
Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain)
Time Frame
Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in Sleep difficulties
Description
Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher 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)
Title
Change in Emotional distress
Description
Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher 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)
Title
Change in Perceived cognitive difficulties
Description
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)
Time Frame
Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary Outcome Measure Information:
Title
Change in Psychological flexibility
Description
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.
Time Frame
Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in Mental Adjustment to Cancer
Description
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)
Time Frame
Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in Emotion regulation
Description
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)
Time Frame
Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in Empowerment
Description
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)
Time Frame
Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Personnality characteristics
Description
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.
Time Frame
Assessed before the intervention (T0)
Title
Fantasy Proneness (imaginative experiences)
Description
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.
Time Frame
Assessed before the intervention (T0)
Title
Expectations and motivation to participate in the chosen intervention
Description
Assessed with 2 VAS (score range from 0 to 10/10, with higher score indicating higher motivation and higher expectations)
Time Frame
Assessed before the intervention (T0)
Title
Personal definition of hypnosis/cognitive trance/meditation
Description
Free text written by the participant
Time Frame
Assessed before the intervention (T0)
Title
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)
Description
Free text written by the participant
Time Frame
Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in Characteristics of the intense memory described above
Description
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.
Time Frame
Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in Mystical characteristics of the intense memory described above
Description
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)
Time Frame
Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in presence during the intense memory described above
Description
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).
Time Frame
Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in the quality of the relationship with the therapist who animated the group sessions
Description
Assessed with a VAS (score range from 0 to 10/10, with higher score indicating better relationship quality).
Time Frame
Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Title
Change in cerebral activity
Description
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.
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.
Title
Change in heart rate
Description
During the EEG, heart rate will be measured (with an electrocardiogram).
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.
Title
Change in body movements
Description
During the EEG, body movements will be measured (with an electromyogram).
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.
Title
Change in body temperature
Description
During the EEG, body temperature will be measured (with a dedicated electrode put on the chest).
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.
Title
Change in respiration
Description
During the EEG, respiration (amplitude, effort) will be measured (with a dedicated belts put on the torso)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Vanhaudenhuyse, PhD
Phone
+3243668482
Email
avanhaudenhuyse@chuliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Grégoire, PhD
Phone
+3243663492
Email
ch.gregoire@uliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivia Gosseries, PhD
Organizational Affiliation
ULiège
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Vanhaudenhuyse, PhD
Phone
+3243668482
Email
avanhaudenhuyse@chuliege.be
First Name & Middle Initial & Last Name & Degree
Charlotte Grégoire, PhD
Phone
+3243663492
Email
ch.gregoire@uliege.be
First Name & Middle Initial & Last Name & Degree
Olivia Gosseries, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35222195
Citation
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.
Results Reference
derived

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Cognitive Trance, Hypnosis and Meditation in Oncology

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