Autohypnosis and Cancerology

Overview

Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was shown that it can reduce the pain, anxiety, fatigue felt by the patient.

Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be an efficient alternative to handle the side effects of chemotherapy.

In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis or are taken in standard care for their chemotherapy.

The life quality score (QLQC30) assessed during and after chemotherapies will determine if auto-hypnosis is a good medical support in chemotherapies' adverse effects management.

The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies could improve the quality of life of cancer affected patients.

Full Title of Study: “Prospective, Randomized Study Aiming to Assess the Benefit of Autohypnosis Learning in the Care of Patients Treated by Adjuvant Chemotherapy for Colorectal or Breast Cancer.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2020

Interventions

  • Other: Autohypnosis learning
    • Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.

Arms, Groups and Cohorts

  • Experimental: Autohypnosis learning
    • In this arm, patients are taught autohypnosis during sessions in groups of 3 to 6 with a qualified hypnotherapist. Sessions are set every two weeks, for a total of 6 sessions. Individual sessions are possible for patients who missed a session.
  • No Intervention: Standard of care
    • In this arm, patients are not taught autohypnosis and are treated according to standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • >20% increase of the EORTC QLQC30 score (annexe 1) at the third week after the last chemotherapy session in the auto-hypnosis arm compared to the standard care arm.
    • Time Frame: 3 weeks after the last chemotherapy session
    • At the third week after the last chemotherapy session, patients answer the quality of life survey (EORTC QLQC30). Arms’ mean score are compared, a minimal difference of 21% is needed for statistical significance.

Secondary Measures

  • Evaluation of auto-hypnosis effects on the life quality and global health of patients at short, mid, and long term.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Patients answer the quality of life survey (EORTC QLQC30) one in two chemotherapy session, or each session for XELOX therapy.
  • Evaluation of auto-hypnosis effects on different components of quality of life.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Quantitative evaluation of QLQ-C30 subdomains
  • Evaluation of auto-hypnosis effects on different components of quality of life specific to breast cancer
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Quantitative evaluation of QLQ-BR23 scores
  • Evaluation of auto-hypnosis effects on different components of quality of life specific to colorectal cancer.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Quantitative evaluation of QLQ-CR29 scores
  • Evaluation of auto-hypnosis effects on drug consumption.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Patients answer a survey about their consumption of different type of drugs : pain-killers, antiemetics, anxiolytics, sleeping drugs.
  • Evaluation of auto-hypnosis effects on fatigue.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Evaluation of fatigue score MFI-20
  • Evaluation of auto-hypnosis impact on anxiety and/or depression.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Evaluation of HADS score
  • Evaluation of auto-hypnosis impact on the global medical handling of their cancer.
    • Time Frame: 3rd week and 6 month after the last treatment
    • Numerical scale of satisfaction survey (from 0 to 10) 0 will mean “very unsatisfied” and 10 will mean “very satisfied”.
  • Evaluation of patient’s satisfaction about auto-hypnosis therapies.
    • Time Frame: 3rd week and 6 month after the last treatment
    • Satisfaction survey about their satisfaction about auto-hypnosis therapies

Participating in This Clinical Trial

Inclusion Criteria

  • Age superior or equal to 18 years old
  • Colorectal or breast cancer history, treated by surgery and that should undergo an adjuvant chemotherapy
  • In the case of breast cancer, adjuvant chemotherapy must involve anthracyclines
  • ECOG performance score < 3
  • Patient must be affiliated or beneficiary of social security or any similar regime

Exclusion Criteria

  • Patients already included in another interventional clinical research protocol
  • Patients unable to proceed to hypnosis treatment due to their speech limitations (poor comprehension and expression of french, deafness, mental illness)
  • Patients protected by French law from clinical inclusion ( pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation…)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Groupe Hospitalier Mutualiste de Grenoble
  • Collaborator
    • TIMC-IMAG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Valerie Armand, +33 (0)4 76 28 50 81, v.armand@ghm-grenoble.fr

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