- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02391740
Therapeutic Patient Education and Cancer Pain (EFFADOL)
March 3, 2016 updated by: Centre Francois Baclesse
THERAPEUTIC PATIENT EDUCATION AND CANCER PAIN
Describe the expectations of therapeutic education for patients in management of cancer pain.
Study Overview
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Caen, France
- Centre François Baclesse
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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
Sampling Method
Probability Sample
Study Population
Patients with cancer and pain
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
describe the expectations of therapeutic education for patients in management of cancer pain
Time Frame: at inclusion
|
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Describe the expectations of close person in therapeutic education on management of cancer pain
Time Frame: at inclusion
|
at inclusion
|
|
Estimate the intensity of the pain
Time Frame: at inclusion
|
at inclusion
|
|
Estimate the echo of the pain on the daily activity of the patient
Time Frame: at inclusion
|
at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
March 12, 2015
First Submitted That Met QC Criteria
March 17, 2015
First Posted (Estimate)
March 18, 2015
Study Record Updates
Last Update Posted (Estimate)
March 4, 2016
Last Update Submitted That Met QC Criteria
March 3, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00239-38
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.