Breast Cancer, Colorectal Cancer
Conditions
Keywords
Cancer, Autohypnosis, Quality of life
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.
Interventions
OTHERAutohypnosis learning
Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.
Sponsors
TIMC-IMAG
AG2R La Mondiale
GEFLUC
Espoir Isère Cancer
Groupe Hospitalier Mutualiste de Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| >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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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 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 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. |
Countries
France
Outcome results
None listed