- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369783
Screening for Social Weaknesses and Coordination Course of Cancer Patients (DEFCOCANCERO)
February 25, 2016 updated by: Institut de Cancérologie de la Loire
Screening for Social Weaknesses and Coordination Course of Cancer Patients: A New Approach by an Expert System IT
The main objective of the study is to validate a methodology with Psychometric tool to measure levels of patients social fragility.
This tool will be dematerialized on a tablet. The answers will be then processed by a decision support algorithm, which automatically send an alert to detection of social fragility of the patient to the nurse navigators.
Study Overview
Study Type
Interventional
Enrollment (Actual)
71
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 Locations
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-
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St Priest en Jarez, France, 42271
- Institut de Cancerologie de La Loire
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All new patients enter ICLN for a diagnosis of cancer
- Patients who can read French or patients who can not read French, but accepting the translation by a close friend or family
- Patient having signed a free and informed consent
Exclusion Criteria:
- Refusal of participation, major patients protected under guardianship.
- Patient can not read French without possibility of translation by a close friend or family
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: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Questionnaire and interview
The patient complete the questionnaire on the tablet to better know their social situation and any difficulties.
Then, he will be interview during thirty minutes with a social worker and a nurse navigator.
At the end of this intervention we will be offered to the patient monitoring and appropriate resources to its situation.
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The aim is to detect social fragility.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire validity
Time Frame: 1 hour
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Outcomes are content validity by expert judges method, appearance validity through a consensus, construct validity through exploratory factor analysis, discriminant validity in relation to the social fragility through univariate analysis, internal validity through factor analysis
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1 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Franck Chauvin, PhD-MD, Institut de Cancerologie de La Loire
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
July 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
February 6, 2015
First Submitted That Met QC Criteria
February 17, 2015
First Posted (Estimate)
February 24, 2015
Study Record Updates
Last Update Posted (Estimate)
February 26, 2016
Last Update Submitted That Met QC Criteria
February 25, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-05
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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