Clinical trial NCT02862002: 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.
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Management
Keywords: opioid therapy
medical oncology.
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment
timeFrame: 21 days
Secondary outcomes:
measure: Treatment adherence morphine
timeFrame: 21 days
measure: Strategies Adjustment disease
timeFrame: 21 days
measure: Anxiety
timeFrame: 21 days
measure: Depression
timeFrame: 21 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille Hôpital de la Timone
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References: