Back to resultsAutohypnosis and Cancerology
Primary Purpose
Colorectal Cancer, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Autohypnosis learning
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Cancer, Autohypnosis, Quality of life
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...)
Sites / Locations
- Groupe hospitalier Mutualiste de Grenoble
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Autohypnosis learning
Standard of care
Arm Description
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.
In this arm, patients are not taught autohypnosis and are treated according to standard of care.
Outcomes
Primary Outcome Measures
>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.
Secondary Outcome Measures
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.
Evaluation of auto-hypnosis effects on different components of quality of life.
Quantitative evaluation of QLQ-C30 subdomains
Evaluation of auto-hypnosis effects on different components of quality of life specific to breast cancer
Quantitative evaluation of QLQ-BR23 scores
Evaluation of auto-hypnosis effects on different components of quality of life specific to colorectal cancer.
Quantitative evaluation of QLQ-CR29 scores
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.
Evaluation of auto-hypnosis effects on fatigue.
Evaluation of fatigue score MFI-20
Evaluation of auto-hypnosis impact on anxiety and/or depression.
Evaluation of HADS score
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".
Evaluation of patient's satisfaction about auto-hypnosis therapies.
Satisfaction survey about their satisfaction about auto-hypnosis therapies
Full Information
NCT ID
NCT03429296
First Posted
February 5, 2018
Last Updated
March 6, 2023
Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Collaborators
TIMC-IMAG, AG2R La Mondiale, GEFLUC, Espoir Isère Cancer
1. Study Identification
Unique Protocol Identification Number
NCT03429296
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Collaborators
TIMC-IMAG, AG2R La Mondiale, GEFLUC, Espoir Isère Cancer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Breast Cancer
Keywords
Cancer, Autohypnosis, Quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autohypnosis learning
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
In this arm, patients are not taught autohypnosis and are treated according to standard of care.
Intervention Type
Other
Intervention Name(s)
Autohypnosis learning
Intervention Description
Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.
Primary Outcome Measure Information:
Title
>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.
Description
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.
Time Frame
3 weeks after the last chemotherapy session
Secondary Outcome Measure Information:
Title
Evaluation of auto-hypnosis effects on the life quality and global health of patients at short, mid, and long term.
Description
Patients answer the quality of life survey (EORTC QLQC30) one in two chemotherapy session, or each session for XELOX therapy.
Time Frame
3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
Title
Evaluation of auto-hypnosis effects on different components of quality of life.
Description
Quantitative evaluation of QLQ-C30 subdomains
Time Frame
3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
Title
Evaluation of auto-hypnosis effects on different components of quality of life specific to breast cancer
Description
Quantitative evaluation of QLQ-BR23 scores
Time Frame
3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
Title
Evaluation of auto-hypnosis effects on different components of quality of life specific to colorectal cancer.
Description
Quantitative evaluation of QLQ-CR29 scores
Time Frame
3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
Title
Evaluation of auto-hypnosis effects on drug consumption.
Description
Patients answer a survey about their consumption of different type of drugs : pain-killers, antiemetics, anxiolytics, sleeping drugs.
Time Frame
3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
Title
Evaluation of auto-hypnosis effects on fatigue.
Description
Evaluation of fatigue score MFI-20
Time Frame
3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
Title
Evaluation of auto-hypnosis impact on anxiety and/or depression.
Description
Evaluation of HADS score
Time Frame
3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
Title
Evaluation of auto-hypnosis impact on the global medical handling of their cancer.
Description
Numerical scale of satisfaction survey (from 0 to 10) 0 will mean "very unsatisfied" and 10 will mean "very satisfied".
Time Frame
3rd week and 6 month after the last treatment
Title
Evaluation of patient's satisfaction about auto-hypnosis therapies.
Description
Satisfaction survey about their satisfaction about auto-hypnosis therapies
Time Frame
3rd week and 6 month after the last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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...)
Facility Information:
Facility Name
Groupe hospitalier Mutualiste de Grenoble
City
Grenoble
ZIP/Postal Code
38028
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Autohypnosis and Cancerology
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