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.

August 9, 2016 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille Hôpital de la Timone
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional 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
Patients in arm E.T.P benefit of the nursing consultation E.T.P,
Other: 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
Other: Standard care
patients receiving standard care of cancer pain.
Active Comparator: standard care
patients receiving standard care of cancer pain.
Other: 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
Other: Standard care
patients receiving standard care of cancer pain.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_3975 - 2756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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