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

Cancer Clinical Trial

— iDEFCO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04015895
• Other study ID #: 18CH176
• Secondary ID: 2018-A03310-55
• Status: Terminated
• Start date: December 4, 2019
• Est. completion date: June 12, 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 437
• Est. completion date: June 12, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	CH Emile Roux	Le Puy-en-Velay
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	Lyon
France	Chu Saint-Etienne	Saint-Étienne
France	Hôpital Privé de la Loire	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population reach	Measured by number of actors who have been used DEFCO tool.	Months: 12
Primary	Population reach	Measured by percentage of patient population included in relation to the target population.	Months: 12
Primary	Population reach	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
Primary	Tool adaptation by professionals	Measured by number of tool variation according to centers.	Months: 12
Primary	Change from 6 months PACIC questionnaire result at 12 months	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
Primary	Evaluation of effectiveness in real life by PPE	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
Primary	Change from baseline FACT-G questionnaire result at 12 months	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
Primary	Change from baseline HAD questionnaire result at 12 months	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
Primary	Evaluation of practices effectiveness by using the tool	Measured by proportion of patients who used the tool compared to patients who were included.	Months: 12
Primary	Evaluation of effectiveness of practices by Personalized Care Project	Measured by number of social components integrated into the Personalized Care Project.	Months: 24
Primary	Evaluation of effectiveness of practices by identification of support systems	Measured of number of support systems in each center.	Months: 24
Primary	Evaluation of effectiveness of practices by patient's satisfaction: questionnaire	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
Primary	Evaluation of effectiveness of practices by caregiver's satisfaction offering the tool: questionnaire	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
Primary	Maintenance and institutionalization	Number of professionals made available for DEFCO tool.	Months: 24
Primary	Change from baseline interview with professional at 12 months	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