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NCT Number: NCT03429296

Autohypnosis and Cancerology

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.

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Key information

Conditions

Colorectal Cancer Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Autohypnosis learning

Other

Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.

Primary outcomes

  1. >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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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".

  9. 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Mutualiste de Grenoble

Other

Collaborators

  • AG2R La Mondiale
  • Espoir Isère Cancer
  • GEFLUC
  • TIMC-IMAG

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2018
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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