Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

NCT ID: NCT03297723

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-18
• Study Completion Date: 2023-01-03

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.

Conditions

Pain Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental arm

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.

Therapeutic education Programm

Intervention Type: OTHER

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.

Controle arm

The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , France

Countries

France

References

Prevost V, Delorme C, Leconte A, Le Chevalier A, Fourel L, Gicquere M, Grach MC, Le Caer F, Clarisse B. Cancer Pain and Patient Education: Strategy, Implementation, Difficulties and Opportunities of EFFADOL, a Regional Collaborative Programme. J Cancer Educ. 2022 Aug;37(4):1089-1098. doi: 10.1007/s13187-020-01924-w. Epub 2020 Nov 19.

Reference Type: DERIVED

PMID: 33215294 (View on PubMed)

Prevost V, Heutte N, Leconte A, Licaj I, Delorme C, Clarisse B; EFFADOL-Group. Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial. BMC Cancer. 2019 Jul 8;19(1):673. doi: 10.1186/s12885-019-5836-5.

Reference Type: DERIVED

PMID: 31286871 (View on PubMed)

Other Identifiers

2016-A01405-46

Identifier Type: -

Identifier Source: org_study_id