Autohypnosis and Cancerology
- Conditions
- Breast CancerColorectal Cancer
- Interventions
- Other: Autohypnosis learning
- Registration Number
- NCT03429296
- Lead Sponsor
- Groupe Hospitalier Mutualiste de Grenoble
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
-
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
- 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...)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autohypnosis learning 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.
- Primary Outcome Measures
Name Time Method >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. 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 Outcome Measures
Name Time Method Evaluation of auto-hypnosis effects on different components of quality of life specific to colorectal cancer. 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 fatigue. 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 effects on different components of quality of life specific to breast cancer 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 impact on anxiety and/or depression. 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 effects on the life quality and global health of patients at short, mid, and long term. 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. 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 drug consumption. 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 patient's satisfaction about auto-hypnosis therapies. 3rd week and 6 month after the last treatment Satisfaction survey about their satisfaction about auto-hypnosis therapies
Evaluation of auto-hypnosis impact on the global medical handling of their cancer. 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".
Trial Locations
- Locations (1)
Groupe hospitalier Mutualiste de Grenoble
🇫🇷Grenoble, France