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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04873661
Other study ID # Trance-Onco
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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