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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02862002

Enrollment

200

Registered

2016-08-10

Start date

2013-08-31

Completion date

2017-03-31

Last updated

2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management

Keywords

opioid therapy, medical oncology.

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.

Interventions

OTHERtherapeutic 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

OTHERStandard care

patients receiving standard care of cancer pain.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain assessment	21 days	Using a digital scale

Secondary

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

Countries

France

Contacts

Primary ContactFlorence DUFFAUD

fduffaud@mail.ap-hm.fr04.91.38.57.08

Backup ContactJeanne-Francette FUTO

jeanne.futo@ap-hm.fr04 91 38 45 47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026