Cognitive Trance, Hypnosis and Meditation in Oncology

NCT ID: NCT04873661

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-07-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hypnosis

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.

Group Type: EXPERIMENTAL

Hypnosis group intervention

Intervention Type: BEHAVIORAL

See arm description

Cognitive trance

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.

Group Type: EXPERIMENTAL

Cognitive trance group intervention

Intervention Type: BEHAVIORAL

See arm description

Meditation

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.

Group Type: EXPERIMENTAL

Meditation group intervention

Intervention Type: BEHAVIORAL

See arm description

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypnosis group intervention

See arm description

Intervention Type: BEHAVIORAL

Cognitive trance group intervention

See arm description

Intervention Type: BEHAVIORAL

Meditation group intervention

See arm description

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FNRS (Télévie)

UNKNOWN

Sponsor Role: collaborator

Fondation contre le cancer

UNKNOWN

Sponsor Role: collaborator

Bial Foundation

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Audrey Vanhaudenhuyse

PhD in Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivia Gosseries, PhD

Role: PRINCIPAL_INVESTIGATOR

ULiège

Locations

University of Liège

Liège, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 39387227 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35222195 (View on PubMed)

Other Identifiers

Trance-Onco

Identifier Type: -

Identifier Source: org_study_id