AzTrials
AzTrials

Non-Metastatic NeoplasmNCT03144154

Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners

A study testing Self-hypnosis + Self-care in people with Non-Metastatic Neoplasm, run by University of Liege at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Hypnosis-based interventions are starting to be tested in order to improve emotional distress and fatigue of cancer patients. However, most of these studies only include breast cancer patients and do no measure long-term effects of such interventions. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteBelgium
Study dates
13 Feb 2017to 18 Sep 2020
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

  • age 18 years or older;
  • Fluency in French;
  • Having received a diagnosis of non-metastatic cancer (all tumour localisations accepted).
  • Having completed all active treatments for no more than a year (surgery, chemotherapy and radiotherapy).
  • Not being in relapse at the time of inclusion
  • Exhibiting some difficulties as established by responses of at least 4 out of 10 on 1 of the 6 chosen items of the Edmonton Symptom Evaluation Scale (Chang, Hwang, \& Feuerman, 2000): physical fatigue, moral fatigue, depression, anxiety, fear of recurrence or ruminations).
  • Wishing to receive help in order to improve the difficulties identified.

Who cannot join

  • Psychiatric disorders, such as dementia, psychosis or delirium, that do not allow to participate in a group intervention or to complete the evaluations

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital of Liege

    Liège, B-4000

Other trials in Belgium

About this study

Hypnosis-based interventions are starting to be tested in order to improve emotional distress and fatigue of cancer patients. However, most of these studies only include breast cancer patients and do no measure long-term effects of such interventions.

Our randomized controlled trial aims to propose to 116 post-treatment cancer patients (all tumour localisations accepted) an 8-week groupal intervention combining hypnosis and self-care techniques.

Read more

Primary outcomes (emotion regulation, emotional distress, fatigue) and secondary outcomes (sleep difficulties, fear of recurrence, attentional bias, conjugal communication) will be investigated at 3 measurement times: before the intervention (T1), 3 months later (T2 - right after the intervention of the experimental group, and right before the intervention of the control group) and again 3 months later (T3 - after the intervention of the control group). Some questionnaires, two relaxation tasks, an attentional task, an actigraph and a smartphone application will be used to collect data. The indirect impact of the intervention on participants' partners will also be measured by questionnaires (emotional distress, conjugal communication).

Data collection has started on March 2017. Our results should bring new knowledge about the efficacy of an hypnosis-based intervention to improve fatigue and well-being in cancer patients, which are often under-diagnosed and under-treated, but also about the indirect efficacy to improve partners' well-being. Those results might contribute to spread this kind of inexpensive intervention in oncology settings.

Being tested
Self-hypnosis + Self-care
Keywords
Cancer, Fatigue, Hypnosis, Self-hypnosis, Self-care, Emotional distress, Cancer survivors
Medical subject headings
Neoplasms, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-hypnosis + Self-careBehavioural

    Our groupal intervention is divided into 8 weekly 2-hour sessions in which one self-hypnosis exercise is proposed to participants. Self-care techniques are also discussed (knowing our own needs, self-respect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.

Study groups in NCT03144154
Study groupRoleWhat they receive
Experimental group : Hypnosis-based interventionExperimentalGroupal intervention combining self-care techniques and self-hypnosis exercises
Receives: Behavioral: Self-hypnosis + Self-care
Control group : Usual careNo interventionControl group receiving usual care but not the intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cancer-Related Fatigue

    A sense of tiredness or exhaustion linked with cancer and its treatments, that is not alleviated by sleep. It will be measured with the Multidimensional Fatigue Inventory (MFI-20) and the Insomnia Severity Index (ISI).

    Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

  2. Change in emotional distress

    Anxiety + Depression, measured with the Hospital Anxiety and Depression Scale (HADS)

    Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

Secondary outcomes (5)

  1. Change in fear of recurrence

    Fear that cancer could return. Measured with the Fear of Cancer Recurence Inventory

    Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

  2. Change in emotion regulation

    The way people deal with their emotions. Measured with one questionnaire (Cognitive Emotion Regulation Questionnaire) and a smartphone application asking participants about their daily emotion and how they deal with it. The application is used during 9 days at each measurement time.

    Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

  3. Change in attentional bias towards threat

    Attentional bias toward emotional information especially negative ones. It is linked with anxiety and will be measured by an computerized task.

    Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

  4. Change in the quality of the conjugal relationship

    Communication about cancer and dyadic coping, measured with questionnaires (Couples' Illness Communication Scale ; Dyadic Coping Inventory). The two partners will complete these questionnaires.

    Measured: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

  5. Change in partners' well-being

    Anxiety and depression of the partners, measured with the HADS.

    Measured: - Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study start13 Feb 2017
  3. Primary completion20 Oct 2019
  4. Study completion18 Sep 2020

Resources

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
Parallel groups
Model description
Participants are randomized into 2 groups: the experimental group receives the intervention immediately while the control group only receives usual care. When the control group has received the intervention and that evaluations have been done for all participants, the control group will receive the intervention (randomized controlled trial).
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144154
Sponsor's protocol ID
Onco-Hypn-Fatigue
Status last verified
Sep 2020
First submitted
1 May 2017
Last updated
28 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baussard L, Ernst M, Diep A, Jerusalem G, Vanhaudenhuyse A, Marie N, Bragard I, Faymonville ME, Gosseries O, Gregoire C. Network Analyses Applied to the Dimensions of Cancer-Related Fatigue in Women With Breast Cancer. Cancer Med. 2024 Oct;13(19):e70268. doi: 10.1002/cam4.70268.

    PubMed 39387227

  • Gregoire C, Faymonville ME, Vanhaudenhuyse A, Jerusalem G, Monseur J, Bragard I. A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness. Int J Clin Exp Hypn. 2023 Oct-Dec;71(4):313-337. doi: 10.1080/00207144.2023.2249044. Epub 2023 Sep 8.

    PubMed 37682079

  • Gregoire C, Faymonville ME, Vanhaudenhuyse A, Jerusalem G, Willems S, Bragard I. Randomized, Controlled Trial of an Intervention Combining Self-Care and Self-Hypnosis on Fatigue, Sleep, and Emotional Distress in Posttreatment Cancer Patients: 1-Year Follow-Up. Int J Clin Exp Hypn. 2022 Apr-Jun;70(2):136-155. doi: 10.1080/00207144.2022.2049973. Epub 2022 Mar 28.

    PubMed 35344461

  • Gregoire C, Faymonville ME, Vanhaudenhuyse A, Jerusalem G, Willems S, Bragard I. Randomized controlled trial of a group intervention combining self-hypnosis and self-care: secondary results on self-esteem, emotional distress and regulation, and mindfulness in post-treatment cancer patients. Qual Life Res. 2021 Feb;30(2):425-436. doi: 10.1007/s11136-020-02655-7. Epub 2020 Oct 6.

    PubMed 33025372

  • Gregoire C, Faymonville ME, Vanhaudenhuyse A, Charland-Verville V, Jerusalem G, Willems S, Bragard I. Effects of an intervention combining self-care and self-hypnosis on fatigue and associated symptoms in post-treatment cancer patients: A randomized-controlled trial. Psychooncology. 2020 Jul;29(7):1165-1173. doi: 10.1002/pon.5395. Epub 2020 Apr 24.

    PubMed 32297396

  • Gregoire C, Faymonville ME, Vanhaudenhuyse A, Charland-Verville V, Jerusalem G, Bragard I. Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol. BMC Cancer. 2018 Nov 15;18(1):1113. doi: 10.1186/s12885-018-5046-6.

    PubMed 30442120

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 1 site 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Cancer-Related Fatigue (time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03144154, which also lists 6 linked publications.

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 28 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in