Clinical trial NCT04015895: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway
Official title: iDEFCO: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Cancer
Social fragilities
Social inequalities
DEFCO
machine learning
cancer care pathway
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2019-07-11
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with cancer will be included.

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.

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

Primary outcomes:
measure: Population reach
timeFrame: Months: 12
measure: Population reach
timeFrame: Months: 12
measure: Population reach
timeFrame: Months: 12
measure: Tool adaptation by professionals
timeFrame: Months: 12
measure: Change from 6 months PACIC questionnaire result at 12 months
timeFrame: Months: 6, 12
measure: Evaluation of effectiveness in real life by PPE
timeFrame: Months: 12
measure: Change from baseline FACT-G questionnaire result at 12 months
timeFrame: Months: 0, 12
measure: Change from baseline HAD questionnaire result at 12 months
timeFrame: Months: 0, 12
measure: Evaluation of practices effectiveness by using the tool
timeFrame: Months: 12
measure: Evaluation of effectiveness of practices by Personalized Care Project
timeFrame: Months: 24
measure: Evaluation of effectiveness of practices by identification of support systems
timeFrame: Months: 24
measure: Evaluation of effectiveness of practices by patient's satisfaction: questionnaire
timeFrame: Months: 12
measure: Evaluation of effectiveness of practices by caregiver's satisfaction offering the tool: questionnaire
timeFrame: Months: 24
measure: Maintenance and institutionalization
timeFrame: Months: 24
measure: Change from baseline interview with professional at 12 months
timeFrame: Months: 0, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Lyon
country: France
facility: Hospices Civils de Lyon - Lyon Sud
city: Lyon
country: France
facility: Hospices Civils de Lyon, Centre Hospitalier Lyon Sud - Oncologie digestive
city: Lyon
country: France
facility: Hospices Civils de Lyon, Groupement Hospitalier Est - Gynécologie
city: Lyon
country: France
facility: Hospices Civils de Lyon, Groupement Hospitalier Nord - Gynécologie
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
city: Saint-Étienne
country: France
facility: Hôpital Privé de la Loire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Bernard +33 TARDY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: