Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Study Overview
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Brief Summary
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Pain is one of the most feared and burdensome symptoms experienced by cancer patients. Its prevalence has been estimated by INCa1 in 2012 at 48% in patients undergoing cancer treatment, and unrelieved pain is directly associated with significantly reduced quality of life (QoL)2. A large part of cancer pain undertreatment can be attributed to patient-related barriers. Patient barriers are multifactorial and often result from a lack of knowledge about cancer pain and its self-management. They mainly consist of misconceptions about opioids and their side effects, nonadherence, and reluctance to alert health care providers to unrelieved pain. Patient education enables people with chronic disease to manage their illness, and has been considered in the field of cancer research as an important strategy to achieve optimal pain control. In Basse-Normandie french region, the Health Regional Plan, pain aspect has identified the theme  pain education program  as a priority. The main endpoint is the decrease of pain interference with daily life (using the Brief Pain Inventory). The experimental group, consisting of cancer pain patients, will benefit from the education program by previously trained health care providers. It will be compared with the control group, consisting with patients whose pain will be conventionally managed before the professional training in therapeutic education.

Official Title
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Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Conditions
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Pain Cancer

Intervention / Treatment
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* Other: Therapeutic education Programm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient suffering from a cancer which diagnosis has been established since at least 1 month Patient who suffers from pain related to the pathology or its treatment: receiving an analgesic treatment since at least 1 month moderate to severe pain intensity in the previous week : average pain score greater than 4 (on a 0-10 numerical rating scale), OR pain leading to insomnia OR 4 daily breakthrough pain, which interferes with daily activities Patient with a life expectancy > or = 6 months Health compatible with the PEP requirements (WHO performance scale > or = 2) Patient v 18 years old Patient able to understand, speak and read French Patient without cognitive dysfunctions Patient with a signed informed consent before inclusion in the study Exclusion Criteria: Primary central nervous system or cerebral metastases Disorders of higher functions documented Evolutionary psychiatric pathology Drug user Abuse of alcohol exceeding WHO recommendations Refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental arm<br>The experimental group will be constituted after the medical staff was trained to TPE. Cancer patients will benefit from a PEP aiming at learning how to better manage their pain. | Other: Therapeutic education Programm<br>* Intervention will include: an identification of educational needs and expectations, a bilateral agreement between patient and medical staff on the priority skills acquirement, a structured educational activities tailored to the patient's need. the making of an educational record.<br>|
| Controle arm<br>The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the decrease of pain impact on daily life activities based on a decrease of 2 points (on a 0-10 scale) between mean values measured before and after the PEP (at 1 month). |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients adhering to the full ETP program (3 workshops), |  | 1 month |