Autohypnosis and Cancerology

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429296
• Other study ID #: 2017/12-SBO-GHMG
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Mutualiste de Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 1, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer

Intervention

Other:
• Autohypnosis learning
Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.

Locations

Country	Name	City	State
France	Groupe hospitalier Mutualiste de Grenoble	Grenoble

Sponsors (5)

Lead Sponsor	Collaborator
Groupe Hospitalier Mutualiste de Grenoble	AG2R La Mondiale, Espoir Isère Cancer, GEFLUC, TIMC-IMAG

Country where clinical trial is conducted

France, 

References & Publications (53)

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	>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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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