Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients

Study Overview
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Brief Summary
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This study aims to assess the impact of a group intervention combining self-hypnosis and self-care techniques on prostate patients' well-being. More specifically, the investigators want to investigate the effects of that intervention on sleep, fatigue and emotional distress of the patients.

Official Title
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Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Self-hypnosis + Self-care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-years-old, ability to read, write and speak French prostate cancer diagnosis treatment with surgery and/or radiotherapy. Exclusion Criteria: metastases cancer recurrence at the moment of inclusion major cognitive or psychiatric disorder.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants who agree to participate in the intervention are assigned in the experimental group, whereas participants who do not agree to participate in the intervention, but agree to answer the questionnaires, are assigned in the control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group : hypnosis + self-care<br>Groupal intervention combining self-care techniques and self-hypnosis exercises | Behavioral: Self-hypnosis + Self-care<br>* Our groupal intervention is divided into 6 monthly 2-hour sessions in which one self-hypnosis exercise is proposed to participants. Self-care techniques are also discussed (knowing our own needs, selfrespect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.<br>|
| No Intervention: Control group : no intervention<br>Control group receiving usual care but not the intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue | A sense of tiredness or exhaustion linked with cancer and its treatments, that is not alleviated by sleep. Measured by the European Organization for Research and Treatment of Cancer - Quality of Life Core Questionnaire-30 (EORTC-QLCQ30). One symptom-related scale (fatigue, score based on 3 items, varies from 0 to 100, 100 being the worst fatigue endured) and the global health status (2 items, score varies from 0 to 100, 100 being the best quality of life) are used in this study. | T0 (before the intervention) and T1 (after the intervention : 6 months later). | 
| Change in emotional distress | Anxiety + Depression, measured with the Hospital Anxiety and Depression Scale (HADS). Scores range (total): 0-42 (0-14: absence of anxio-depressive disorder ; 15-42: presence of anxio-depressive disorder). Two scales: anxiety and depression. For each, scores range 0-21 (0-7: absence of anxious or depressive disorder; 8-10: possibility of an anxious or depressive disorder; 11-21: presence of anxious or depressive disorder). | T0 (before the intervention) and T1 (after the intervention : 6 months later). | 
| Change in sleep difficulties | Sleep difficulties (difficulties to stay asleep, to fall asleep...) and their severity. Measured by the Insomnia Severity Index. One score is calculated and ranges from 0 to 22 (0-7: absence of insomnia; 8-14: subclinical insomnia; 15-21: moderate insomnia; 22-28: severe insomnia). | T0 (before the intervention) and T1 (after the intervention : 6 months later). |