- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015895
Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway (iDEFCO)
iDEFCO: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Clermont-Ferrand, France
- Centre Jean Perrin
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Le Puy-en-Velay, France
- CH Emile Roux
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Lyon, France
- Hospices Civils de Lyon - Lyon Sud
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Lyon, France
- Hospices Civils de Lyon, Centre Hospitalier Lyon Sud - Oncologie digestive
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Lyon, France
- Hospices Civils de Lyon, Groupement Hospitalier Est - Gynécologie
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Lyon, France
- Hospices Civils de Lyon, Groupement Hospitalier Nord - Gynécologie
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Saint-Étienne, France
- Chu Saint-Etienne
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Saint-Étienne, France
- Hôpital privé de la Loire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient diagnosed for cancer (solid or hematological) since 15 days maximum
- Age over 18 years
- Affiliated with or entitled to a social security scheme
Exclusion Criteria:
- Refusal to participate
- Patient unable to understand the study process
- Patient with documented history of cognitive or psychiatric disorders.
- Patient under tutorship or curatorship
- Patient not understanding French
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient with cancer
Patient with cancer will be included.
They will have to answer at DEFCO tool.
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The Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system DEFCO tool is questionnaire to identify their social vulnerabilities.
A neural network instantly identifies the patient's fragility and sends the result by email to the professionals identified in the organization of each center.
These professionals then relay to the social workers in order to take care of the patient's fragility.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Population reach
Time Frame: Months: 12
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Measured by number of actors who have been used DEFCO tool.
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Months: 12
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Population reach
Time Frame: Months: 12
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Measured by percentage of patient population included in relation to the target population.
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Months: 12
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Population reach
Time Frame: Months: 12
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Measured by rate of participation: number of patients included by physicians, proportion of patient who completed the tool, proportion of patients detected as socially fragile.
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Months: 12
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Tool adaptation by professionals
Time Frame: Months: 12
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Measured by number of tool variation according to centers.
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Months: 12
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Change from 6 months PACIC questionnaire result at 12 months
Time Frame: Months: 6, 12
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Measured by comparison Patient Assessment of Chronic Illness Care Questionnaire (PACIC) by patient at 6 and 12 months after the inclusion. Patient Assessment of Chronic Illness Care Questionnaire (PACIC) is a questionnaire which evaluates care during chronic illnesses with minimum score at 0 (bad care assessment) and maximum score at 130 (good care assessment). |
Months: 6, 12
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Evaluation of effectiveness in real life by PPE
Time Frame: Months: 12
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Measured by comparison of Picker Patient Experience Questionnaire (PPE) between patients at 12 months after the inclusion. Picker Patient Experience Questionnaire (PPE) is a questionnaire which measures the patient experience with minimum score at 0 (no problem with health care access) and maximum score at 100 (problem with health care access). |
Months: 12
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Change from baseline FACT-G questionnaire result at 12 months
Time Frame: Months: 0, 12
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Measured by comparison Functional Assessment of Cancer Therapy-General Questionnaire (FACT-G) by patient at the baseline and 12 months after. Functional Assessment of Cancer Therapy-General Questionnaire (FACT-G) is a questionnaire which measures the quality of life of the patient with minimum score at 0 (low quality of life) and maximum score at 108 (high quality of life). |
Months: 0, 12
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Change from baseline HAD questionnaire result at 12 months
Time Frame: Months: 0, 12
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Measured evolution of Hospital Anxiety and Depression Questionnaire (HAD) at the baseline and 12 months after. Hospital Anxiety and Depression Questionnaire (HAD) is a questionnaire which measures evolution of patient anxiety by 2 sub-scores :
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Months: 0, 12
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Evaluation of practices effectiveness by using the tool
Time Frame: Months: 12
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Measured by proportion of patients who used the tool compared to patients who were included.
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Months: 12
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Evaluation of effectiveness of practices by Personalized Care Project
Time Frame: Months: 24
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Measured by number of social components integrated into the Personalized Care Project.
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Months: 24
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Evaluation of effectiveness of practices by identification of support systems
Time Frame: Months: 24
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Measured of number of support systems in each center.
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Months: 24
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Evaluation of effectiveness of practices by patient's satisfaction: questionnaire
Time Frame: Months: 12
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Measured by satisfaction questionnaire to the patient.
Satisfaction questionnaire to the patient had 6 questions with minimum score at 0 (no contented) and maximum score at 18 (contented).
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Months: 12
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Evaluation of effectiveness of practices by caregiver's satisfaction offering the tool: questionnaire
Time Frame: Months: 24
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Measured by satisfaction questionnaire to the caregiver.
Satisfaction questionnaire to the caregiver had 7 questions with minimum score at 0 (no contented) and maximum score at 21 (contented).
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Months: 24
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Maintenance and institutionalization
Time Frame: Months: 24
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Number of professionals made available for DEFCO tool.
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Months: 24
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Change from baseline interview with professional at 12 months
Time Frame: Months: 0, 24
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Assessed by interviews with professionals who have used DEFCO tool.
Interviews with professionals will be realized at the baseline and the end at the study.
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Months: 0, 24
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bernard +33 TARDY, MD PhD, Chu Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18CH176
- 2018-A03310-55 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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