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

Sponsor

University of Liege (Other)

Overall Status

Completed

CT.gov ID

NCT03144154

Collaborator

King Baudouin Foundation (Other), Jules Bordet Institute (Other), Fonds National de la Recherche Scientifique (Other)

104

Enrollment

Location

Arms

43.1

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Metastatic Neoplasm	Behavioral: Self-hypnosis + Self-care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 13, 2017

Actual Primary Completion Date :

Oct 20, 2019

Actual Study Completion Date :

Sep 18, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Cancer-Related Fatigue [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).
Change in emotional distress [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)

Secondary Outcome Measures

Change in fear of recurrence [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
Change in emotion regulation [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.
Change in attentional bias towards threat [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.
Change in the quality of the conjugal relationship [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.
Change in partners' well-being [- Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI)]
Anxiety and depression of the partners, measured with the HADS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria are:

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.

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