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Clinical Trials/NCT04015895
NCT04015895
Terminated
N/A

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

Centre Hospitalier Universitaire de Saint Etienne8 sites in 1 country437 target enrollmentDecember 4, 2019
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
437
Locations
8
Primary Endpoint
Population reach
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2019
End Date
June 12, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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).

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.

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).

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)

Evaluation of effectiveness of practices by identification of support systems

Time Frame: Months: 24

Measured of number of support systems in each center.

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).

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.

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).

Tool adaptation by professionals

Time Frame: Months: 12

Measured by number of tool variation according to centers.

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).

Maintenance and institutionalization

Time Frame: Months: 24

Number of professionals made available for DEFCO tool.

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.

Study Sites (8)

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