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

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2020-09-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Metastatic Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group : Hypnosis-based intervention

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

Group Type EXPERIMENTAL

Self-hypnosis + Self-care

Intervention Type BEHAVIORAL

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.

Control group : Usual care

Control group receiving usual care but not the intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No