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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-hypnosis + Self-care
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group : hypnosis + self-care

    Control group : no intervention

    Arm Description

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

    Control group receiving usual care but not the intervention

    Outcomes

    Primary Outcome Measures

    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.
    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).
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2018
    Last Updated
    February 5, 2018
    Sponsor
    University of Liege
    Collaborators
    Free University of Brussels
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03423927
    Brief Title
    Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients
    Official Title
    Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 14, 2013 (Actual)
    Primary Completion Date
    June 15, 2016 (Actual)
    Study Completion Date
    June 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Liege
    Collaborators
    Free University of Brussels

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group : hypnosis + self-care
    Arm Type
    Experimental
    Arm Description
    Groupal intervention combining self-care techniques and self-hypnosis exercises
    Arm Title
    Control group : no intervention
    Arm Type
    No Intervention
    Arm Description
    Control group receiving usual care but not the intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-hypnosis + Self-care
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Fatigue
    Description
    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.
    Time Frame
    T0 (before the intervention) and T1 (after the intervention : 6 months later).
    Title
    Change in emotional distress
    Description
    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).
    Time Frame
    T0 (before the intervention) and T1 (after the intervention : 6 months later).
    Title
    Change in sleep difficulties
    Description
    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).
    Time Frame
    T0 (before the intervention) and T1 (after the intervention : 6 months later).

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marie-Elisabeth Faymonville
    Organizational Affiliation
    University of Liege
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29929493
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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