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

Non-Metastatic Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05943301
• Other study ID #: 2018/204
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: July 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-Metastatic Neoplasm

Intervention

Behavioral:
• Self-hypnosis/self-care
Learning phase of self-hypnosis/self-care

Locations

Country	Name	City	State
Belgium	University	Liège
Belgium	University of Liège	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	Fondation Benoit

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)