Non-Metastatic Neoplasm
Conditions
Keywords
Cancer, Hypnosis, Self-care, Cognition
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.
Interventions
BEHAVIORALSelf-hypnosis/self-care
Learning phase of self-hypnosis/self-care
Sponsors
Fondation Benoit
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The investigator will not know which participant is in the learning phase or in the waiting list.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 : 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 : 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. |
| 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 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. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 : 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 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 : 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 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 | 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 : 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. |
| 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 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). |
Countries
Belgium
Outcome results
None listed