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

NCT ID: NCT05943301

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Metastatic Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
The investigator will not know which participant is in the learning phase or in the waiting list.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Self-hypnosis/self-care

Intervention Type BEHAVIORAL

Learning phase of self-hypnosis/self-care

Control group

The control goup has usual care and no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self-hypnosis/self-care

Learning phase of self-hypnosis/self-care

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Benoit

UNKNOWN

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Audrey Vanhaudenhuyse

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Liège

Liège, , Belgium

Site Status

University

Liège, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/204

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Autohypnosis and Cancerology
NCT03429296 COMPLETED NA