Hypnosis for Patients Treated With Adjuvant Chemotherapy for Breast Cancer(HYPNOVAL)

NCT03250130 | Completed

• 1 other identifier: ICM-URC-2014/ 31
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• proportion of patients rated as being compliant to self-hypnosis

  The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy. Primary endpoint is the proportion of patients rated as being compliant to self-hypnosis sessions during adjuvant chemotherapy (6 sessions). A patient is considered as compliant if it achieves at least 2/3 of the planned self-hypnosis sessions, that is, 4 of 6 planned sessions.

  through study completion, an average of 2 years

Secondary Outcomes (1)

• Impact of hypnosis on the tolerance of the CT

  through study completion, an average of 2 years

Study Arms (1)

Hypnosis

EXPERIMENTAL

The patient achieve self-hypnosis sessions in these chemotherapy treatments

Behavioral: hypnosis

Interventions

hypnosis BEHAVIORAL

The patient achieve self-hypnosis sessions in these chemotherapy treatments

Hypnosis

Eligibility Criteria

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

You may qualify if:

• Female, age \> 18 years-old
• Without previous practice of hypnosis
• Patient with diagnosis of breast cancer
• Patient receiving an adjuvant chemotherapy for at least 3 months with an indication of radiotherapy after chemotherapy
• Patient accepting the principle of the study with a signed written informed consent
• Patient affiliated to French Social Security

You may not qualify if:

• Male
• Age \< 18 years
• Patient refusing hypnosis
• Pregnancy, breast-feeding, or lack of effective contraception in female patients with reproductive potential.
• Patient with psychological or mental disorders under psychotropic treatments (lithium, neuroleptics)
• Not ability to speak and read French, deaf and/or mute

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de montpellier

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michel FABBRO

  Institut régional du Cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: August 15, 2017
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: June 6, 2017
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)