Therapeutic Patient Education and Cancer Pain | NCT02391740

Studies
Therapeutic Patient Education and Cancer Pain

NCT02391740

Sponsor

Centre Francois Baclesse

Status

Completed

Last Update Posted

Mar 4, 2016Estimated

Enrollment

75Actual

Phase

Not provided

Conditions

Cancer

Interventions

Questionnaire

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

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Mar 12, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 18, 2015Estimated

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

Mar 3, 2016

Last Update Posted Date

Mar 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
describe the expectations of therapeutic education for patients in management of cancer pain		at inclusion

Secondary Outcomes

Measure	Description	Time Frame
Describe the expectations of close person in therapeutic education on management of cancer pain		at inclusion
Estimate the intensity of the pain		at inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with cancer diagnosed for at least one month
Patient with pain from the tumor or its treatment
Patients with a life expectancy ≥ 6 months
Health condition compatible with the requirements of the program (WHO performance scale < or= 2)
Age over 18 years
Patient able to understand, speak and read French
Absence of cognitive impairment

Exclusion Criteria:

Primary cancer of the central nervous system or brain metastases
Disorders of the documented higher functions
Evolutionary psychiatric pathology
Drug User
Abusive alcohol consumption than the WHO recommendations (or 3 glasses of wine per day)
Refusal to participate

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

Patients with cancer and pain

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
centre François Baclesse		Caen			France

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
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided