Prostate Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALSelf-hypnosis + Self-care
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.
Sponsors
Free University of Brussels
University of Liege
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue | T0 (before the intervention) and T1 (after the intervention : 6 months later). | 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. |
| Change in emotional distress | T0 (before the intervention) and T1 (after the intervention : 6 months later). | 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). |
| Change in sleep difficulties | T0 (before the intervention) and T1 (after the intervention : 6 months later). | 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). |
Outcome results
None listed