Study of the Impact of Non-pharmacological Techniques on Cognitive Complaints in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Metastatic Neoplasm

Intervention / Treatment
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* Behavioral: Self-hypnosis/self-care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Behavioral: Self-hypnosis/self-care<br>* Learning phase of self-hypnosis/self-care<br>|
| No Intervention: Control group<br>The control goup has usual care and no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective cognitive difficulties : Perceived cognitive impairments | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in subjective cognitive difficulties : Comments by others | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in subjective cognitive difficulties : Perceived cognitive abilities | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in subjective cognitive difficulties : Impact on quality of life | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in objective cognitive difficulties : Verbal long term memory | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in objective cognitive difficulties : Attention | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in objective cognitive difficulties : Processing speed | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in objective cognitvie difficulties : Inhibition | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in objective cognitvie difficulties : mental flexibility | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in objective cognitvie difficulties : working memory | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in objective cognitvie difficulties : executive functions | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Impact on return-to-work | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in emtional distress : Anxiety | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in emtional distress : Depression | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in fatigue : General fatigue | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in fatigue : Physical fatigue | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in fatigue : Mental fatigue | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in fatigue : Motivational decrease | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in fatigue | 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. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in fatigue : Weekly agenda | Qualitative questionnaire concerning the sleep habits of participants. They have to give information concerning their sleeping habits. | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 
| Change in quality of life | 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). | T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-care, Hypnosis, Cognition, Cancer