- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971773
PSYCHOLOGICAL CARE AND HYPNOSIS IN PATIENTS WITH CANCER
May 31, 2019 updated by: Assistance Publique Hopitaux De Marseille
The general aim of the research that we propose to implement is to study the potential benefits of hypnosis in the psycho-social care of patients with cancer.
The main goal of this study is to measure the effects of hypnosis sessions on quality of life, anxiety and patient adjustment strategies.
The effects of these interventions will be the subject of quantitative measurement via standardized scales in pre- and post-intervention situations of the potential effects of hypno-therapeutic intervention in cancer patients and
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Florence Duffaud, MD/PhD
- Email: florence.duffaud@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13005
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient with any kind of cancer and followed by a psychologist
Exclusion Criteria:
- Patient with neurological trouble
- Patient with psychiatric decompassation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Patient ongoing hypnosis sessions
|
patient with cancer will undergo sessions of hypnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life scale
Time Frame: 36 months
|
QLQC30 assessment
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anxiety scales
Time Frame: 36 months
|
Edmonton Symptom Assessment System
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 19, 2018
Primary Completion (ANTICIPATED)
April 18, 2021
Study Completion (ANTICIPATED)
April 18, 2022
Study Registration Dates
First Submitted
May 31, 2019
First Submitted That Met QC Criteria
May 31, 2019
First Posted (ACTUAL)
June 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 3, 2019
Last Update Submitted That Met QC Criteria
May 31, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2018-A00472-53 (OTHER: Assistance Publique Hôpitaux de Marseille)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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