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

July 4, 2023 updated by: Audrey Vanhaudenhuyse, University of Liege

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in subjective cognitive difficulties : Perceived cognitive impairments
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in subjective cognitive difficulties : Comments by others
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in subjective cognitive difficulties : Perceived cognitive abilities
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in subjective cognitive difficulties : Impact on quality of life
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in objective cognitive difficulties : Verbal long term memory
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in objective cognitive difficulties : Attention
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in objective cognitive difficulties : Processing speed
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in objective cognitvie difficulties : Inhibition
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in objective cognitvie difficulties : mental flexibility
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in objective cognitvie difficulties : working memory
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in objective cognitvie difficulties : executive functions
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Impact on return-to-work
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in emtional distress : Anxiety
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in emtional distress : Depression
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in fatigue : General fatigue
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in fatigue : Physical fatigue
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in fatigue : Mental fatigue
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in fatigue : Motivational decrease
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in fatigue
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in fatigue : Weekly agenda
Time Frame: 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.
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Change in quality of life
Time Frame: 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).
T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liege

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation Benoit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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