Autohypnosis and Cancerology

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Colorectal Cancer, Breast Cancer

Intervention / Treatment
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* Other: Autohypnosis learning


Participation Criteria
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Eligibility Criteria
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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...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Zelen : patients will be randomized according to the Zelen randomization design (as described in Zelen M. Randomized consent designs for clinical trials: An update. Stats in Med. 1990;9:645-656)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autohypnosis learning<br>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. | Other: Autohypnosis learning<br>* Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.<br>|
| No Intervention: Standard of care<br>In this arm, patients are not taught autohypnosis and are treated according to standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >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. | 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. | 3 weeks after the last chemotherapy session | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Autohypnosis, Quality of life