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.

NCT ID: NCT02862002

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-03-31

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.

Detailed Description

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Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Therapeutic Patient Education (E.T.P)of type "caratif

Patients in arm E.T.P benefit of the nursing consultation E.T.P,

Group Type EXPERIMENTAL

therapeutic education of type "caratif

Intervention Type OTHER

study the effects of a therapeutic education program type "caratif", based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology

Standard care

Intervention Type OTHER

patients receiving standard care of cancer pain.

standard care

patients receiving standard care of cancer pain.

Group Type ACTIVE_COMPARATOR

therapeutic education of type "caratif

Intervention Type OTHER

study the effects of a therapeutic education program type "caratif", based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology

Standard care

Intervention Type OTHER

patients receiving standard care of cancer pain.

Interventions

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therapeutic education of type "caratif

study the effects of a therapeutic education program type "caratif", based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology

Intervention Type OTHER

Standard care

patients receiving standard care of cancer pain.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Assistance Publique Hôpitaux de Marseille Hôpital de la Timone

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Florence DUFFAUD

Role: CONTACT

04.91.38.57.08

Jeanne-Francette FUTO

Role: CONTACT

04 91 38 45 47

Facility Contacts

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Florence DUFFAUD

Role: primary

04.91.38.57.08 ext. +33

Other Identifiers

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RC12_3975 - 2756

Identifier Type: -

Identifier Source: org_study_id

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