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CancerNCT04873661

Cognitive Trance, Hypnosis and Meditation in Oncology

A study testing Hypnosis group intervention, Cognitive trance group intervention and Meditation group intervention in people with Cancer and Distress, Emotional, run by University of Liege at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Distress, Emotional, Pain
What is being tested?
Hypnosis group intervention, Cognitive trance group intervention and Meditation group intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteBelgium
Study dates
1 Jan 2021to 31 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.

Who cannot join

  • < 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University of Liège

    Liège, 4000

Other trials in Belgium

About this study

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

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.

Being tested
Hypnosis group intervention, Cognitive trance group intervention, Meditation group intervention
Keywords
Hypnosis, Cognitive trance, Meditation, Cancer, Oncology, Quality of life, Neurophysiology, Phenomenology
Medical subject headings
Neoplasms, Pain, Fatigue, Parasomnias, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypnosis group interventionBehavioural

    See arm description

  • Cognitive trance group interventionBehavioural

    See arm description

  • Meditation group interventionBehavioural

    See arm description

Study groups in NCT04873661
Study groupRoleWhat they receive
HypnosisExperimentalIn 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.
Receives: Behavioral: Hypnosis group intervention
Cognitive tranceExperimentalThe 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.
Receives: Behavioral: Cognitive trance group intervention
MeditationExperimentalThe 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.
Receives: Behavioral: Meditation group intervention
Control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fatigue

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

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

  2. Change in Pain

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

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

  3. 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.

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

  4. 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

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

  5. 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)

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

Secondary outcomes (18)

  1. 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.

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

  2. 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)

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

  3. 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)

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

  4. 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)

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

  5. 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.

    Measured: Assessed before the intervention (T0)

  6. 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.

    Measured: Assessed before the intervention (T0)

  7. 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)

    Measured: Assessed before the intervention (T0)

  8. Personal definition of hypnosis/cognitive trance/meditation

    Free text written by the participant

    Measured: Assessed before the intervention (T0)

  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)

    Free text written by the participant

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

  10. 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.

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

  11. 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)

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

  12. 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).

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

  13. 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).

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

  14. 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.

    Measured: 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.

  15. Change in heart rate

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

    Measured: 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.

  16. Change in body movements

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

    Measured: 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.

  17. Change in body temperature

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

    Measured: 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.

  18. Change in respiration

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start1 Jan 2021
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04873661
Sponsor's protocol ID
Trance-Onco
Status last verified
Apr 2025
First submitted
26 Apr 2021
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39387227

  • 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.

    PubMed 35222195

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis group intervention, Cognitive trance group intervention and Meditation group intervention in people with Cancer and Distress, Emotional, run by University of Liege at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04873661, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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