From the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research

Study Overview
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Brief Summary
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The use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals [1,2]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this learning [3]. Nevertheless, in France, the therapeutic educational programs, built according to the standards of the therapeutic education (TE), are still very rare in cancer research [4]. In May 2012, a therapeutic educational program for these patients has been developed in the oncology department of the Teaching Hospital of Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: MODAP (action-research).

Detailed Description
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At the diagnosis, 25 to 30 % of renal cancer patients present a metastatic disease. The prognosis remains dark in spite of the advent of the targeted therapies from 2007. Actually, the use of oral targeted therapies, most of the time carried out on an outpatient basis (sunitinib in particular), draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals [1,2]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this learning [3]. Nevertheless, the therapeutic educational programs, built according to the standards of the therapeutic education (TE), are still very rare in cancer research [4]: multiplicity of the pathology (a cancer, cancers), multiplicity of the patients' experiences, the difficulty of implementation? In May 2012, in front of the experience told by the patients and the professionals in the context of metastatic renal cancer, the members of the oncology department of the Teaching Hospital of Bordeaux, the therapeutic educational Federation, the Coordination Cancer Centre (3C), an anthropologist, an expert patient and a patient's association developed a therapeutic educational program for these patients [current approval]. This program, built on the model of the TE in France, becomes here an object of research: MODAP (action-research).

Official Title
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From the Model to the Adaptation of a Therapeutic Education Program in Cancer Research: the Case of Renal Cancer Patients Treated by Oral Treatments, Multidisciplinary Approach

Conditions
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Health Services Research

Intervention / Treatment
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* Other: Interviews with 2 oncologists and 10 patients
* Other: Interviews with 15 patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age = 18 years old Metastatic Renal cancer (carcinoma with clear cells and other subcategories) Indication of a first line of treatment of therapy targeted by Sutent © General WHO 0-2 state Life expectancy = 12 weeks Agree to participate in MODAP (Therapeutic Education) Exclusion Criteria: History of other cancer History of severe psychiatric affection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage 1<br>Patients without therapeutic education | Other: Interviews with 2 oncologists and 10 patients<br> <br> |
| Stage 2<br>Patients with therapeutic education | Other: Interviews with 15 patients<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health quality of life with QLQC30 questionnaire |  | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate to the program stages | Quantitative data analysis of questionnaires about the health program satisfaction Participation rate to the program stages Attendance to the program stages Management of therapeutic plan : number of rendez-vous changed by the patient or healers | Two years | 
| Number of rendez-vous changed by the patient |  | Two years | 
| Number of rendez-vous changed by the healers |  | Two years | 
| Number of therapeutic education procedures stages versus the number realized |  | Two years | 
| Number of calls by nurses | Management of therapeutic plan : number of rendez-vous change by the patient or healers, number of therapeutic education procedures stages versus the number realized, number of calls by nurses | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oral Therapy, Compliance, Anthropology, Psychology