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.

Pain Management Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862002
• Other study ID #: RC12_3975 - 2756
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2016
• Last updated: August 9, 2016
• Start date: August 2013
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Florence DUFFAUD
• Phone: 04.91.38.57.08
• Email: fduffaud[@]mail.ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neoplasms
• Pain Management

Intervention

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
• Standard care
patients receiving standard care of cancer pain.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille Hôpital de la Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	Using a digital scale	21 days	No
Secondary	Treatment adherence morphine	Digital Scale / self-administered questionnaire of adherence of Girerd et al [78]	21 days	No
Secondary	Strategies Adjustment disease	Scale MAC (Mental Adjustment to Cancer Scale) French Version: Cayrou et al, 2001 [82]	21 days	No
Secondary	Anxiety	Scale HADS (Hospital anxiety and depression seale, French version: Sigmund and Snaith) [83]	21 days	No
Secondary	Depression	Scale HADS (Hospital anxiety and depression seale, French version: Sigmund and Snaith) [83]	21 days	No