Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Pain Cancer Clinical Trial

— EFFADOL-K  

Official title:

Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297723
• Other study ID #: 2016-A01405-46
• Status: Recruiting
• Start date: December 18, 2017
• Est. completion date: December 2023

Study information

• Verified date: May 2021
• Source: Centre Francois Baclesse
• Contact: Claire DELORME, MD
• Phone: 0231455050
• Email: c.delorme[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Cancer

Intervention

Other:
• Therapeutic education Programm
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.

Locations

Country	Name	City	State
France	centre Hospitalier d'Alençon	Alençon
France	Centre Hospitalier d'Argentan	Argentan
France	Centre Hospitalier AVRANCHES-GRANVILLE	Avranches
France	Centre Hospitalier Bayeux	Bayeux
France	Centre François Baclesse	Caen
France	CHU CAEN	Caen
France	Hopital privé Paul d'Egine	Champigny-sur-Marne
France	Centre Hospitalier de Cherbourg	Cherbourg-Octeville
France	Ch Dieppe	Dieppe
France	Centre Hospitalier de Flers	Flers
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier Lisieux	Lisieux
France	Hopital Européen Georges Pompidou (HEGP)	Paris
France	Centre Hospitalier de Saint-lo	Saint-Lô
France	Ghpso Senlis	Senlis
France	IGR	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The proportion of patients adhering to the full ETP program (3 workshops),		1 month