Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

• Conditions: Pain Cancer
• Interventions: Other: Therapeutic education Programm

• Registration Number: NCT03297723
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Study Start: 2017-12-18
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental arm	Therapeutic education Programm	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The proportion of patients adhering to the full ETP program (3 workshops),	1 month

Trial Locations

Locations (16)

Ch Dieppe; 🇫🇷 Dieppe, France

Hopital privé Paul d'Egine; 🇫🇷 Champigny-sur-Marne, France

CHU CAEN; 🇫🇷 Caen, France

Centre Hospitalier Lisieux; 🇫🇷 Lisieux, France

Centre Hospitalier de Flers; 🇫🇷 Flers, France

centre Hospitalier d'Alençon; 🇫🇷 Alençon, France

Centre Hospitalier d'Argentan; 🇫🇷 Argentan, France

Centre Hospitalier AVRANCHES-GRANVILLE; 🇫🇷 Avranches, France

Hopital Européen Georges Pompidou (HEGP); 🇫🇷 Paris, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Hospitalier Bayeux; 🇫🇷 Bayeux, France

Centre Hospitalier de Cherbourg; 🇫🇷 Cherbourg-Octeville, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Hospitalier de Saint-lo; 🇫🇷 Saint-Lô, France

IGR; 🇫🇷 Villejuif, France

Ghpso Senlis; 🇫🇷 Senlis, France