Cognitive Trance, Hypnosis and Meditation in Oncology

University of Liege

Status: Active, not recruiting

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

Treatments: Behavioral: Hypnosis group intervention; Behavioral: Cognitive trance group intervention; Behavioral: Meditation group intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04873661

Trance-Onco

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Hypnosis

Experimental group

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.

Treatment:

Behavioral: Hypnosis group intervention

Cognitive trance

Experimental group

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.

Treatment:

Behavioral: Cognitive trance group intervention

Meditation

Experimental group

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.

Treatment:

Behavioral: Meditation group intervention

Control group

No Intervention group

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.