Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway (iDEFCO)

October 31, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

iDEFCO: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway

Social inequalities in the face of cancer are significant in all countries. They are characterized by higher mortality among people may be in the lower socioeconomic category. The care pathway may also be a source of inequality or accentuate inequalities. Socially vulnerable patients must be provided with appropriate care. It is therefore necessary to identify patients with such social vulnerabilities as early as possible and to take them into account throughout the care process. To meet this need, the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") was designed and conducted by the Centre Hygée at the Lucien Neuwirth Cancer Institute (ICLN) in 2014 and 2015, in partnership with an industrial engineering research laboratory, the DISP ("Décision & Information pour les Systèmes de Production"). Its objective was to develop a tool for systematic screening of social fragility, involving few caregivers and making it possible to identify patients most at risk of social maladjustment. The choice was made to develop a self-administered questionnaire using tablets connected to a neural network. Since its implementation, the deployment of the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") tool at the Lucien Neuwirth Cancer Institute (ICLN) has required several training and awareness-raising activities to strengthen the motivation of the various stakeholders. These same actors have also implemented different strategies to optimize the functioning of the tool. Developed in a specialized institution, this tool must demonstrate, in this second stage of the project, it transferability and it possibilities of implementation in other structures. It is also necessary to evaluate it in terms of it is impact, particularly on the fluidity of care pathways and on the social consequences of the disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to evaluate the implementation of the DEFCO ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") social fragility tracking tool over one year.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
437

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

  • France
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Le Puy-en-Velay, France
        • CH Emile Roux
      • Lyon, France
        • Hospices Civils de Lyon - Lyon Sud
      • Lyon, France
        • Hospices Civils de Lyon, Centre Hospitalier Lyon Sud - Oncologie digestive
      • Lyon, France
        • Hospices Civils de Lyon, Groupement Hospitalier Est - Gynécologie
      • Lyon, France
        • Hospices Civils de Lyon, Groupement Hospitalier Nord - Gynécologie
      • Saint-Étienne, France
        • CHU Saint-Etienne
      • Saint-Étienne, France
        • Hôpital Privé de la Loire

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with cancer will be included.

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient with cancer
Patient with cancer will be included. They will have to answer at DEFCO tool.
Other: DEFCO tool
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Population reach
Time Frame: Months: 12
Measured by number of actors who have been used DEFCO tool.
Months: 12
Population reach
Time Frame: Months: 12
Measured by percentage of patient population included in relation to the target population.
Months: 12
Population reach
Time Frame: Months: 12
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.
Months: 12
Tool adaptation by professionals
Time Frame: Months: 12
Measured by number of tool variation according to centers.
Months: 12
Change from 6 months PACIC questionnaire result at 12 months
Time Frame: Months: 6, 12

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
Evaluation of effectiveness in real life by PPE
Time Frame: Months: 12

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
Change from baseline FACT-G questionnaire result at 12 months
Time Frame: Months: 0, 12

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
Change from baseline HAD questionnaire result at 12 months
Time Frame: Months: 0, 12

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 :

  • Anxiety sub-score: with minimum score at 0 (no anxiety) and maximum score at 21 (anxiety)
  • Depression sub-score: with minimum score at 0 (no depression) and maximum score at 21 (depression)
Months: 0, 12
Evaluation of practices effectiveness by using the tool
Time Frame: Months: 12
Measured by proportion of patients who used the tool compared to patients who were included.
Months: 12
Evaluation of effectiveness of practices by Personalized Care Project
Time Frame: Months: 24
Measured by number of social components integrated into the Personalized Care Project.
Months: 24
Evaluation of effectiveness of practices by identification of support systems
Time Frame: Months: 24
Measured of number of support systems in each center.
Months: 24
Evaluation of effectiveness of practices by patient's satisfaction: questionnaire
Time Frame: Months: 12
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).
Months: 12
Evaluation of effectiveness of practices by caregiver's satisfaction offering the tool: questionnaire
Time Frame: Months: 24
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).
Months: 24
Maintenance and institutionalization
Time Frame: Months: 24
Number of professionals made available for DEFCO tool.
Months: 24
Change from baseline interview with professional at 12 months
Time Frame: Months: 0, 24
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.
Months: 0, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ligue contre le cancer, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernard +33 TARDY, MD PhD, CHU Saint-Etienne

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18CH176
  • 2018-A03310-55 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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