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

NCT05943301 | Withdrawn DMC

• 1 other identifier: 2018/204
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Metastatic Neoplasm

Keywords

Cancer; Hypnosis; Self-care; Cognition

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (9)

• Change in emtional distress : Anxiety

  T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)

• Change in emtional distress : Depression

  T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)

• Change in fatigue : General fatigue

  T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)

• Change in fatigue : Physical fatigue

  T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)

• Change in fatigue : Mental fatigue

  T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control goup has usual care and no intervention.

Interventions

Self-hypnosis/self-care BEHAVIORAL

Learning phase of self-hypnosis/self-care

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major
• Fluency in French
• End of surgery and/or chimiotherapy and/or radiotherapy : 1-12 months.
• Cognitive complaints

You may not qualify if:

• Brain cancer
• Metastatic cancer
• Psychiatric disorder
• Neurologic disorder
• Neuropsychological assessment made within 3 months
• Drug addiction
• Alcoholism

Sponsors & Collaborators

• University of Liege: lead
• Fondation Benoit: collaborator

Study Sites (2)

University of Liège

Liège, 4000, Belgium

Location

University

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will not know which participant is in the learning phase or in the waiting list.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: July 13, 2023
• Study Start: September 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: October 30, 2021
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)