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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423927
• Other study ID #: Hypnosis Prostate Cancer
• Status: Completed
• Phase: N/A
• First received: January 30, 2018
• Last updated: February 5, 2018
• Start date: October 14, 2013
• Est. completion date: June 15, 2016

Study information

• Verified date: February 2018
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 15, 2016
• Est. primary completion date: June 15, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Liege	Free University of Brussels

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).