Clinical trial NCT05943301: Study of the Impact of Non-pharmacological Techniques on Cognitive Complaints in Cancer Patients
Official title: Study of the Impact of Non-pharmacological Techniques (Self-hypnosis/Self-care) on the Well-being, Cognitive Complaints and Return-to-work in Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-Metastatic Neoplasm
Keywords: Cancer
Hypnosis
Self-care
Cognition
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Fondation Benoit
First posted: 2023-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be tested by the experimenter on T0. One month later, the experimenter will assess all participants (T1). After that, a person external from the study will randomize participants to the experimental group or the controle group. The experimental group will proceed to an 8 week (1 session of 2 hours a week) training programme of self-hypnosis/self-care with a therapist specialized in hypnosis, while the group control will be on waiting list. After this learning phase, all participant will be assessed once again (T2). Then, the group control will enter the learning phase. After the completion of this learning phase/waiting list, all participants will proceed to a last evaluation (T3) to assess the self-hypnosis/self-care effect over time.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer diagnosis generates a number of physical (pain, nausea and fatigue) and psychological implications for the patient. At the psychological level, there are high levels of emotional distress (anxiety and depression) and cognitive impairments such as memory, attentional and information processing deficits, that can undermine the quality of life. This last decade has shown great progress in cancer treatment allowing cancer patients, many of whom are of working age, to survive. Unfortunately, cancer diagnosis and treatment induce various symptoms necessitating the patient to interrupt or quit his occupational status. Hypnosis has been used in the past few years to treat these psychological and physical symptoms, be it at the moment of diagnosis, during and/or after the cancer treatments. A large amount of studies has shown a positive effect of hypnosis in cancer patients notably upon anxiety, emotional distress and fatigue, three factors that can negatively affect cognitive functions. The purpose of our study is to investigate the effect of a non-pharmacological treatment that combines self-hypnosis and self-care on well-being, cognitive complaints and return-to- work within a population of cancer patients. Our hypothesis is that, by reducing emotional distress and fatigue, self-hypnosis/self-care will reduce the cognitive difficulties of cancer patients, foster return-to-work, and eventually improve the patients' global quality of life.


Eligibility criteria: Inclusion Criteria:

* Major
* Fluency in French
* End of surgery and/or chimiotherapy and/or radiotherapy : 1-12 months.
* Cognitive complaints

Exclusion Criteria:

* Brain cancer
* Metastatic cancer
* Psychiatric disorder
* Neurologic disorder
* Neuropsychological assessment made within 3 months
* Drug addiction
* Alcoholism

Primary outcomes:
measure: Change in subjective cognitive difficulties : Perceived cognitive impairments
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in subjective cognitive difficulties : Comments by others
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in subjective cognitive difficulties : Perceived cognitive abilities
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in subjective cognitive difficulties : Impact on quality of life
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in objective cognitive difficulties : Verbal long term memory
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in objective cognitive difficulties : Attention
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in objective cognitive difficulties : Processing speed
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in objective cognitvie difficulties : Inhibition
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in objective cognitvie difficulties : mental flexibility
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in objective cognitvie difficulties : working memory
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in objective cognitvie difficulties : executive functions
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Impact on return-to-work
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Secondary outcomes:
measure: Change in emtional distress : Anxiety
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in emtional distress : Depression
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in fatigue : General fatigue
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in fatigue : Physical fatigue
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in fatigue : Mental fatigue
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in fatigue : Motivational decrease
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in fatigue
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in fatigue : Weekly agenda
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
measure: Change in quality of life
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liège
city: Liège
country: Belgium
facility: University
Study officials:
References: