iDEFCO: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 437
- 试验地点
- 8
- 主要终点
- Population reach
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed for cancer (solid or hematological) since 15 days maximum
- •Age over 18 years
- •Affiliated with or entitled to a social security scheme
排除标准
- •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
结局指标
主要结局
Population reach
时间窗: 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
时间窗: 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
时间窗: Months: 24
Measured by number of social components integrated into the Personalized Care Project.
Change from 6 months PACIC questionnaire result at 12 months
时间窗: 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
时间窗: 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
时间窗: Months: 24
Measured of number of support systems in each center.
Change from baseline FACT-G questionnaire result at 12 months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Months: 12
Measured by number of tool variation according to centers.
Evaluation of effectiveness of practices by patient's satisfaction: questionnaire
时间窗: 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
时间窗: Months: 24
Number of professionals made available for DEFCO tool.
Change from baseline interview with professional at 12 months
时间窗: 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.
次要结局
未报告次要终点