PSYCHOLOGICAL CARE AND HYPNOSIS IN PATIENTS WITH CANCER | NCT03971773

Studies
PSYCHOLOGICAL CARE AND HYPNOSIS IN PATIENTS WITH CANCER

NCT03971773

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Jun 3, 2019Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Hypnosis and Cancer

Interventions

hypnosis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A00472-53	Other Identifier	Assistance Publique Hôpitaux de Marseille

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2018Actual

Primary Completion Date

Apr 18, 2021Estimated

Completion Date

Apr 18, 2022Estimated

First Submitted Date

May 31, 2019

First Submission Date that Met QC Criteria

May 31, 2019

First Posted Date

Jun 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2019

Last Update Posted Date

Jun 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient ongoing hypnosis sessions	Experimental		Other: hypnosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hypnosis	Other	patient with cancer will undergo sessions of hypnosis	Patient ongoing hypnosis sessions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of life scale	QLQC30 assessment	36 months

Secondary Outcomes

Measure	Description	Time Frame
anxiety scales	Edmonton Symptom Assessment System	36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with any kind of cancer and followed by a psychologist

Exclusion Criteria:

Patient with neurological trouble
Patient with psychiatric decompassation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Florence Duffaud, MD/PhD	Contact			florence.duffaud@ap-hm.fr

Overall Officials

Name	Affiliation	Role
Emilie Garrido	Assistance Publique Hopitaux De Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance publique hopitaux de Marseille	Recruiting	Marseille		13005	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006990	Hypnosis

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided