Autohypnosis and Cancerology

NCT03429296 | Completed

• 1 other identifier: 2017/12-SBO-GHMG
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Breast Cancer

Keywords

Cancer; Autohypnosis; Quality of life

Outcome Measures

Primary Outcomes (1)

• >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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Autohypnosis learning

EXPERIMENTAL

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.

Other: Autohypnosis learning

Standard of care

NO INTERVENTION

In this arm, patients are not taught autohypnosis and are treated according to standard of care.

Interventions

Autohypnosis learning OTHER

Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.

Autohypnosis learning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Groupe Hospitalier Mutualiste de Grenoble: lead
• TIMC-IMAG: collaborator
• AG2R La Mondiale: collaborator
• GEFLUC: collaborator
• Espoir Isère Cancer: collaborator

Study Sites (1)

Groupe hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

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Related Links

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MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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")

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: May 23, 2018
• Primary Completion: January 21, 2022
• Study Completion: July 1, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)