Clinical trial NCT04873661: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Distress, Emotional
Pain
Fatigue
Sleep Disturbance
Cognitive Impairment
Keywords: Hypnosis
Cognitive trance
Meditation
Cancer
Oncology
Quality of life
Neurophysiology
Phenomenology
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: FNRS (Télévie)
name: Fondation contre le cancer
name: Bial Foundation
name: Centre Hospitalier Universitaire de Liege
First posted: 2021-05-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Fatigue
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Pain
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Sleep difficulties
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Emotional distress
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Perceived cognitive difficulties
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary outcomes:
measure: Change in Psychological flexibility
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Mental Adjustment to Cancer
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Emotion regulation
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Empowerment
timeFrame: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Personnality characteristics
timeFrame: Assessed before the intervention (T0)
measure: Fantasy Proneness (imaginative experiences)
timeFrame: Assessed before the intervention (T0)
measure: Expectations and motivation to participate in the chosen intervention
timeFrame: Assessed before the intervention (T0)
measure: Personal definition of hypnosis/cognitive trance/meditation
timeFrame: Assessed before the intervention (T0)
measure: 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)
timeFrame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Characteristics of the intense memory described above
timeFrame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in Mystical characteristics of the intense memory described above
timeFrame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in presence during the intense memory described above
timeFrame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in the quality of the relationship with the therapist who animated the group sessions
timeFrame: Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
measure: Change in cerebral activity
timeFrame: 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.
measure: Change in heart rate
timeFrame: 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.
measure: Change in body movements
timeFrame: 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.
measure: Change in body temperature
timeFrame: 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.
measure: Change in respiration
timeFrame: 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.
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liège
Study officials:
affiliation: ULiège
name: Olivia Gosseries, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.