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

NCT03423927 | Completed

• 1 other identifier: Hypnosis Prostate Cancer
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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).

Study Arms (2)

Intervention group : hypnosis + self-care

EXPERIMENTAL

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

Behavioral: Self-hypnosis + Self-care

Control group : no intervention

NO INTERVENTION

Control group receiving usual care but not the intervention

Interventions

Self-hypnosis + Self-care BEHAVIORAL

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.

Intervention group : hypnosis + self-care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years-old,
• ability to read, write and speak French
• prostate cancer diagnosis
• treatment with surgery and/or radiotherapy.

You may not qualify if:

• metastases
• major cognitive or psychiatric disorder.

Sponsors & Collaborators

• University of Liege: lead
• Free University of Brussels: collaborator

Related Publications (1)

• 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.

  PMID: 29929493 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Hypnosis; Self Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marie-Elisabeth Faymonville

  University of Liege

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: October 14, 2013
• Primary Completion: June 15, 2016
• Study Completion: June 15, 2016
• Last Updated: February 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share