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

September 24, 2020 updated by: Isabelle Bragard, University of Liege

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • 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
      • Liege, Belgium, B-4000
        • University Hospital of Liege

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria are:

  1. age 18 years or older;
  2. Fluency in French;
  3. Having received a diagnosis of non-metastatic cancer (all tumour localisations accepted).
  4. Having completed all active treatments for no more than a year (surgery, chemotherapy and radiotherapy).
  5. Not being in relapse at the time of inclusion
  6. 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).
  7. Wishing to receive help in order to improve the difficulties identified.

Exclusion Criteria:

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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group : Hypnosis-based intervention
Groupal intervention combining self-care techniques and self-hypnosis exercises
Behavioral: Self-hypnosis + Self-care
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.
No Intervention: Control group : Usual care
Control group receiving usual care but not the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cancer-Related Fatigue
Time Frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
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
Time Frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fear of recurrence
Time Frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Fear that cancer could return. Measured with the Fear of Cancer Recurence Inventory
T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Change in emotion regulation
Time Frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
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.
T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Change in attentional bias towards threat
Time Frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Attentional bias toward emotional information especially negative ones. It is linked with anxiety and will be measured by an computerized task.
T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Change in the quality of the conjugal relationship
Time Frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Communication about cancer and dyadic coping, measured with questionnaires (Couples' Illness Communication Scale ; Dyadic Coping Inventory). The two partners will complete these questionnaires.
T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Change in partners' well-being
Time Frame: - Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI)
Anxiety and depression of the partners, measured with the HADS.
- Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI)

Collaborators and Investigators

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

Sponsor

University of Liege

Collaborators

Jules Bordet Institute
King Baudouin Foundation
Fonds National de la Recherche Scientifique

Investigators

  • Study Director: Marie-Elisabeth Faymonville, CHU de Liège - Université de Liège

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 13, 2017

Primary Completion (Actual)

October 20, 2019

Study Completion (Actual)

September 18, 2020

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Onco-Hypn-Fatigue

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

product manufactured in and exported from the U.S.

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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