Clinical trial NCT03429296: Autohypnosis and Cancerology
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Breast Cancer
Keywords: Cancer
Autohypnosis
Quality of life
Lead sponsor: Groupe Hospitalier Mutualiste de Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: AG2R La Mondiale
name: GEFLUC
name: Espoir Isère Cancer
First posted: 2018-02-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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")
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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...)

Primary outcomes:
measure: >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.
timeFrame: 3 weeks after the last chemotherapy session
Secondary outcomes:
measure: Evaluation of auto-hypnosis effects on the life quality and global health of patients at short, mid, and long term.
timeFrame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
measure: Evaluation of auto-hypnosis effects on different components of quality of life.
timeFrame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
measure: Evaluation of auto-hypnosis effects on different components of quality of life specific to breast cancer
timeFrame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
measure: Evaluation of auto-hypnosis effects on different components of quality of life specific to colorectal cancer.
timeFrame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
measure: Evaluation of auto-hypnosis effects on drug consumption.
timeFrame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
measure: Evaluation of auto-hypnosis effects on fatigue.
timeFrame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
measure: Evaluation of auto-hypnosis impact on anxiety and/or depression.
timeFrame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
measure: Evaluation of auto-hypnosis impact on the global medical handling of their cancer.
timeFrame: 3rd week and 6 month after the last treatment
measure: Evaluation of patient's satisfaction about auto-hypnosis therapies.
timeFrame: 3rd week and 6 month after the last treatment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Groupe hospitalier Mutualiste de Grenoble
Study officials:
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