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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Non-Metastatic Neoplasm
• Intervention / Treatment: Behavioral: Self-hypnosis/self-care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • University of Liege
  • Liège, Belgium, 4000
    • University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; Learning phase of self-hypnosis/self-care
No Intervention: Control group; The control goup has usual care and no intervention.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Liege
• Collaborators: Fondation Benoit

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Hypnosis; Cognition; Self-care
• Other Study ID Numbers: 2018/204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No