Study of the Impact of Non-pharmacological Techniques on Cognitive Complaints in Cancer Patients
- Conditions
- Non-Metastatic Neoplasm
- Interventions
- Behavioral: Self-hypnosis/self-care
- Registration Number
- NCT05943301
- Lead Sponsor
- University of Liege
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Major
- Fluency in French
- End of surgery and/or chimiotherapy and/or radiotherapy : 1-12 months.
- Cognitive complaints
- Brain cancer
- Metastatic cancer
- Psychiatric disorder
- Neurologic disorder
- Neuropsychological assessment made within 3 months
- Drug addiction
- Alcoholism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental group Self-hypnosis/self-care Self-hypnosis/self-care intervention : It is an 8-week 2 hour-session (one session per week) of self-hypnosis/ self-care learning. Participants are given strategies to learn self-care (knowing your own needs, self-respect, communication, etc.), each strategie is discussed for participant to understand them and thus applie them correctly in daily living. An hypnosis exercice is also realised at the end of each session.
- Primary Outcome Measures
Name Time Method Change in objective cognitive difficulties : Verbal long term memory T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on verbal long term memory will be assessed by means the Buschke Selective Reminding Test (Buschke, 1973). According to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitvie difficulties : Inhibition T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on inhibition abilities will be assessed by means of the first part of the Stroop test (Stroop, 1935). According to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitvie difficulties : executive functions T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on executive functions will be assessed by means of the Wisconsin Card Sorting Test (David et al., 1948). According to the sex and the subject's age, the test gives us a score and the norms.
Impact on return-to-work T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) For people who continued to work at time of recruitment, Work Design questionnaire will be administered Morgeson \& Hymphrey, 2006). Scale raging from 0 to 5 (0=not at all; 5=exactly).
Change in subjective cognitive difficulties : Perceived cognitive abilities T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Perceived cognitive abilities" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=not at all; 4=very much).
Change in subjective cognitive difficulties : Impact on quality of life T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Impact on quality of life" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=not at all; 4=very much).
Change in objective cognitvie difficulties : working memory T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on mental flexibility abilities will be assessed by means of the subtest "Working memory" of the Test of Attentional Performance 2.3.1 (Zimmermann \& Fimm, 2002). Computerized test, according to the sex and the subject's age, the test gives us a score and the norms.
Change in subjective cognitive difficulties : Perceived cognitive impairments T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Perceived cognitive impairments" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=never; 4=several times a day).
Change in subjective cognitive difficulties : Comments by others T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Comments by others" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=never; 4=several times a day).
Change in objective cognitive difficulties : Attention T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on attention abilities will be assessed by means of the subtest "Phasic alertness" of the Test of Attentional Performance 2.3.1 (Zimmermann \& Fimm, 2002). Computerized test, according to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitive difficulties : Processing speed T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on processing speed abilities will be assessed by means of the first part of the Stroop test (Stroop, 1935). According to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitvie difficulties : mental flexibility T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on mental flexibility abilities will be assessed by means of the subtest "Flexibility" of the Test of Attentional Performance 2.3.1 (Zimmermann \& Fimm, 2002). Computerized test, according to the sex and the subject's age, the test gives us a score and the norms.
- Secondary Outcome Measures
Name Time Method Change in fatigue : General fatigue T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on fatigue will be assessed by means of the subscale "general fatigue" of the Multidimensional Fatigue Inventory (Smets et al., 1995). Scale ranging from 1 to 4 (1=not agree at all; 4=agree completely).
Change in emtional distress : Anxiety T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on anxiety and despression will be assessed by means of the Hopsital Anxiety and Depression Scale (Zigmond \& Snaith, 1983). Scale ranging from 0 to 3 (0=never; 4=always).
Change in quality of life T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The improvement of quality of life will be assessed my means of the european Organization for Reasearch and Treatment of Cancer QLQ-C30 version 3.0 (E Aaronson et al., 1993). Scale ranging from 1 to 4 (1=not at all; 4=excellent).
Change in fatigue T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on fatigue will be assessed by means of the Multidimensional Fatigue Inventory (MFI; Smets et al., 1995) and an 1-week agenda.
Change in fatigue : Mental fatigue T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on fatigue will be assessed by means of the subscale "mental fatigue" of the Multidimensional Fatigue Inventory (Smets et al., 1995). Scale ranging from 1 to 4 (1=not agree at all; 4=agree completely).
Change in emtional distress : Depression T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on anxiety and despression will be assessed by means of the Hopsital Anxiety and Depression Scale (Zigmond \& Snaith, 1983). Scale ranging from 0 to 3 (0=alwaysr; 4=never).
Change in fatigue : Physical fatigue T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on fatigue will be assessed by means of the subscale "physical fatigue" of the Multidimensional Fatigue Inventory (Smets et al., 1995). Scale ranging from 1 to 4 (1=not agree at all; 4=agree completely).
Change in fatigue : Motivational decrease T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) The impact of self-hypnosis/self-care on fatigue will be assessed by means of the subscale "motivational decrease" of the Multidimensional Fatigue Inventory (Smets et al., 1995). Scale ranging from 1 to 4 (1=not agree at all; 4=agree completely).
Change in fatigue : Weekly agenda T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) Qualitative questionnaire concerning the sleep habits of participants. They have to give information concerning their sleeping habits.
Trial Locations
- Locations (2)
University
🇧🇪Liège, Belgium
University of Liège
🇧🇪Liège, Belgium