CanceriDEFCONCT04015895
Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway
An observational study of Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- DEFCO tool
- How many people
- 437 participants
- Where
- 8 sitesFrance
- Study dates
- 4 Dec 2019to 12 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with cancer will be included.
Who may be able to join
- Patient diagnosed for cancer (solid or hematological) since 15 days maximum
- Age over 18 years
- Affiliated with or entitled to a social security scheme
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Jean Perrin
Clermont-Ferrand
CH Emile Roux
Le Puy-en-Velay
Hospices Civils de Lyon - Lyon Sud
Lyon
Hospices Civils de Lyon, Centre Hospitalier Lyon Sud - Oncologie digestive
Lyon
Hospices Civils de Lyon, Groupement Hospitalier Est - Gynécologie
Lyon
Hospices Civils de Lyon, Groupement Hospitalier Nord - Gynécologie
Lyon
Chu Saint-Etienne
Saint-Etienne
Hôpital Privé de la Loire
Saint-Etienne
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- DEFCO tool
- Keywords
- Cancer, Social fragilities, Social inequalities, DEFCO, machine learning, cancer care pathway
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEFCO toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with cancer | Patient with cancer will be included. They will have to answer at DEFCO tool. Receives: Other: DEFCO tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population reach
Measured by number of actors who have been used DEFCO tool.
Measured: Months: 12
Population reach
Measured by percentage of patient population included in relation to the target population.
Measured: Months: 12
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.
Measured: Months: 12
Tool adaptation by professionals
Measured by number of tool variation according to centers.
Measured: Months: 12
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).
Measured: Months: 6, 12
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).
Measured: Months: 12
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).
Measured: Months: 0, 12
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)
Measured: Months: 0, 12
Evaluation of practices effectiveness by using the tool
Measured by proportion of patients who used the tool compared to patients who were included.
Measured: Months: 12
Evaluation of effectiveness of practices by Personalized Care Project
Measured by number of social components integrated into the Personalized Care Project.
Measured: Months: 24
Evaluation of effectiveness of practices by identification of support systems
Measured of number of support systems in each center.
Measured: Months: 24
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).
Measured: Months: 12
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).
Measured: Months: 24
Maintenance and institutionalization
Number of professionals made available for DEFCO tool.
Measured: Months: 24
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.
Measured: Months: 0, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start4 Dec 2019
- Primary completion30 May 2022
- Study completion12 Jun 2023
Why it stopped: low inclusion rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Bernard +33 TARDY, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015895
- Sponsor's protocol ID
- 18CH176
- Other IDs
- 2018-A03310-55
- Acronym
- iDEFCO
- Status last verified
- Feb 2023
- First submitted
- 28 Jun 2019
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iDEFCO: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway
- ClinicalTrials.gov ID
- NCT04015895
- Acronym / sponsor ID
- iDEFCO / 18CH176
- Conditions
- Cancer
- Keywords
- Cancer, Social fragilities, Social inequalities, DEFCO, machine learning, cancer care pathway
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low inclusion rates
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with cancer | – | Other: DEFCO toolPatient with cancer will be included. They will have to answer at DEFCO tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cancer will be included.
Key inclusion criteria (3 listed)
- Patient diagnosed for cancer (solid or hematological) since 15 days maximum
- Age over 18 years
- Affiliated with or entitled to a social security scheme
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEFCO toolThe 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. | Other | Patient with cancer |
Primary outcome
Population reach
Time frame: Months: 12
Measured by number of actors who have been used DEFCO tool.
Population reach
Time frame: Months: 12
Measured by percentage of patient population included in relation to the target population.
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.
Tool adaptation by professionals
Time frame: Months: 12
Measured by number of tool variation according to centers.
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).
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).
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).
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 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 Personalized Care Project
Time frame: Months: 24
Measured by number of social components integrated into the Personalized Care Project.
Evaluation of effectiveness of practices by identification of support systems
Time frame: Months: 24
Measured of number of support systems in each center.
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).
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).
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.
Results and safety
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard +33 TARDY, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population reach (time frame: Months: 12). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.