Non-Metastatic NeoplasmNCT05943301
Study of the Impact of Non-pharmacological Techniques on Cognitive Complaints in Cancer Patients
A study testing Self-hypnosis/self-care in people with Non-Metastatic Neoplasm, run by University of Liege at 2 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Metastatic Neoplasm
- What is being tested?
- Self-hypnosis/self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2019to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major
- Fluency in French
- End of surgery and/or chimiotherapy and/or radiotherapy : 1-12 months.
- Cognitive complaints
Who cannot join
- Brain cancer
- Metastatic cancer
- Psychiatric disorder
- Neurologic disorder
- Neuropsychological assessment made within 3 months
- Drug addiction
- Alcoholism
Trial locations and contacts
2 sites in 1 country.
About this study
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
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
- Being tested
- Self-hypnosis/self-care
- Keywords
- Cancer, Hypnosis, Self-care, Cognition
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosis/self-careBehavioural
Learning phase of self-hypnosis/self-care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-hypnosis/self-care |
| Control group | No intervention | The control goup has usual care and no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Sep 2019
- Primary completion30 Jul 2020
- Study completion30 Oct 2021
Why it stopped: Problems with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Metastatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Benoit
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943301
- Sponsor's protocol ID
- 2018/204
- Status last verified
- Jul 2023
- First submitted
- 11 Feb 2019
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05943301
- Acronym / sponsor ID
- 2018/204
- Conditions
- Non-Metastatic Neoplasm
- Keywords
- Cancer, Hypnosis, Self-care, Cognition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems with recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Fondation Benoit
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Self-hypnosis/self-careSelf-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. |
| Control group | No intervention | –The control goup has usual care and no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major
- Fluency in French
- End of surgery and/or chimiotherapy and/or radiotherapy : 1-12 months.
- Cognitive complaints
Key exclusion criteria (7 listed)
- Brain cancer
- Metastatic cancer
- Psychiatric disorder
- Neurologic disorder
- Neuropsychological assessment made within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-hypnosis/self-careLearning phase of self-hypnosis/self-care | Behavioural | Experimental group |
Primary outcome
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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).
9 secondary outcomes
Change in emtional distress : Anxiety
Time frame: 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)
Change in fatigue : General fatigue
Time frame: 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)
Change in fatigue : Mental fatigue
Time frame: 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)
Change in fatigue
Time frame: 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)
Change in quality of life
Time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnosis/self-care in people with Non-Metastatic Neoplasm, run by University of Liege at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.