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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Self-hypnosis + Self-care

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group : hypnosis + self-care; Groupal intervention combining self-care techniques and self-hypnosis exercises	Behavioral: Self-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.
No Intervention: Control group : no intervention; 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 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).

Collaborators and Investigators

• Sponsor: University of Liege
• Collaborators: Free University of Brussels
• Investigators: Study Director: Marie-Elisabeth Faymonville, University of Liege

Publications and helpful links

General Publications

• Gregoire C, Nicolas H, Bragard I, Delevallez F, Merckaert I, Razavi D, Waltregny D, Faymonville ME, Vanhaudenhuyse A. Efficacy of a hypnosis-based intervention to improve well-being during cancer: a comparison between prostate and breast cancer patients. BMC Cancer. 2018 Jun 22;18(1):677. doi: 10.1186/s12885-018-4607-z.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2013
• Primary Completion (Actual): June 15, 2016
• Study Completion (Actual): June 15, 2016

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Hypnosis Prostate Cancer

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