Measuring the Effects of Therapeutic Education Program Caratif Patient Under Strong Opioids Versus Standard Taking Charge of Patient Pain Receiving Opioid Therapy in Medical Oncology.

Study Overview
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Brief Summary
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A first empirical evidence on the difficulties of observance of morphine in cancer patients invited a multidisciplinary team to initiate an innovative quality approach. It shows the lack of transcript of a comprehensive care causing a problem for monitoring actions undertaken for the relief of pain. In addition, two exploratory studies targeting the expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids. The E.T.P, public health priority, provides a framework for action and improving care. In oncology, the involvement of the patient in pain relief and management of opioids represents an axis of intervention more appropriate. Yet, it is not found in literature. In our department, we conduct an experimental therapeutic education program type caratif and a nurse consultation FTE receiving opioids on the model of nursing care of J. Watson (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient experience). The ETP folder and its tools have been continuously validated with patients. The heart of the educational process is in the patient's complex path neat oncology and relies on interaction and creativity between patient and caregivers.

Official Title
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Measuring the Effects of Therapeutic Education Program Caratif Patient Under Strong Opioids Versus Standard Taking Charge of Patient Pain Receiving Opioid Therapy in Medical Oncology.

Conditions
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Pain Management

Intervention / Treatment
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* Other: therapeutic education of type caratif
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Cancer patients receiving opioids Suffering from pain caused by their disease or treatment with chemotherapy and / or radiotherapy and / or surgery Supported within the oncology or palliative care Receiving at least 3 courses of chemotherapy Having read, understood and signed the informed consent Subject beneficiary of a social security scheme or an equivalent - Exclusion Criteria: adults subject to a legal protection measure or unable to consent Non-beneficiaries of a social security scheme, persons deprived of liberty by a judicial or administrative decision, patients with neurological or psychiatric disorders

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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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Patient Education (E.T.P)of type caratif<br>Patients in arm E.T.P benefit of the nursing consultation E.T.P, | Other: therapeutic education of type caratif<br>* study the effects of a therapeutic education program type caratif, based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology<br>Other: Standard care<br>* patients receiving standard care of cancer pain.<br>|
| Active Comparator: standard care<br>patients receiving standard care of cancer pain. | Other: therapeutic education of type caratif<br>* study the effects of a therapeutic education program type caratif, based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology<br>Other: Standard care<br>* patients receiving standard care of cancer pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Using a digital scale | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment adherence morphine | Digital Scale / self-administered questionnaire of adherence of Girerd et al [78] | 21 days | 
| Strategies Adjustment disease | Scale MAC (Mental Adjustment to Cancer Scale) French Version: Cayrou et al, 2001 [82] | 21 days | 
| Anxiety | Scale HADS (Hospital anxiety and depression seale, French version: Sigmund and Snaith) [83] | 21 days | 
| Depression | Scale HADS (Hospital anxiety and depression seale, French version: Sigmund and Snaith) [83] | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid therapy, medical oncology.