NCT03144154

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

May 1, 2017

Last Update Submit

September 24, 2020

Conditions

Non-Metastatic Neoplasm

Keywords

CancerFatigueHypnosisSelf-hypnosisSelf-careEmotional distressCancer survivors

Outcome Measures

Primary Outcomes (2)

  • 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).

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

  • Change in emotional distress

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

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

Secondary Outcomes (5)

  • Change in fear of recurrence

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

  • Change in emotion regulation

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

  • Change in attentional bias towards threat

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

  • Change in the quality of the conjugal relationship

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

  • Change in partners' well-being

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

Study Arms (2)

Experimental group : Hypnosis-based intervention

EXPERIMENTAL

Groupal intervention combining self-care techniques and self-hypnosis exercises

Behavioral: Self-hypnosis + Self-care

Control group : Usual care

NO INTERVENTION

Control group receiving usual care but not the intervention

Interventions

Self-hypnosis + Self-careBEHAVIORAL

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.

Experimental group : Hypnosis-based intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liege

Liège, B-4000, Belgium

Location

Related Publications (6)

  • 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.

    PMID: 39387227DERIVED

  • 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.

    PMID: 37682079DERIVED

  • 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.

    PMID: 35344461DERIVED

  • 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.

    PMID: 33025372DERIVED

  • 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.

    PMID: 32297396DERIVED

  • 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.

    PMID: 30442120DERIVED

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

HypnosisSelf Care

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marie-Elisabeth Faymonville

    CHU de Liège - Université de Liège

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 8, 2017

Study Start

February 13, 2017

Primary Completion

October 20, 2019

Study Completion

September 18, 2020

Last Updated

September 28, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)