Cognitive Trance, Hypnosis and Meditation in Oncology

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04873661
• Other study ID #: Trance-Onco
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Liege
• Contact: Audrey Vanhaudenhuyse, PhD
• Phone: +3243668482
• Email: avanhaudenhuyse[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cognitive Impairment
• Distress, Emotional
• Dyssomnias
• Fatigue
• Pain
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Hypnosis group intervention
See arm description
• Cognitive trance group intervention
See arm description
• Meditation group intervention
See arm description

Locations

Country	Name	City	State
Belgium	University of Liège	Liège

Sponsors (5)

Lead Sponsor	Collaborator
University of Liege	Bial Foundation, Centre Hospitalier Universitaire de Liege, FNRS (Télévie), Fondation contre le cancer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fatigue	Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Primary	Change in Pain	Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain)	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Primary	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.	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Primary	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	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Primary	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)	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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.	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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)	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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)	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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)	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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.	Assessed before the intervention (T0)
Secondary	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.	Assessed before the intervention (T0)
Secondary	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)	Assessed before the intervention (T0)
Secondary	Personal definition of hypnosis/cognitive trance/meditation	Free text written by the participant	Assessed before the intervention (T0)
Secondary	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	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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.	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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)	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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).	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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).	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Secondary	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.	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.
Secondary	Change in heart rate	During the EEG, heart rate will be measured (with an electrocardiogram).	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.
Secondary	Change in body movements	During the EEG, body movements will be measured (with an electromyogram).	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.
Secondary	Change in body temperature	During the EEG, body temperature will be measured (with a dedicated electrode put on the chest).	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.
Secondary	Change in respiration	During the EEG, respiration (amplitude, effort) will be measured (with a dedicated belts put on the torso)	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.