Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

NCT03297723 | Completed

• 1 other identifier: 2016-A01405-46
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The proportion of patients adhering to the full ETP program (3 workshops),

  1 month

Study Arms (2)

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.

Other: Therapeutic education Programm

Controle arm

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

Interventions

Therapeutic education Programm 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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient suffering from a cancer and suffering from pain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• National Cancer Institute, France: collaborator

Study Sites (16)

centre Hospitalier d'Alençon

Alençon, France

Location

Centre Hospitalier d'Argentan

Argentan, France

Location

Centre Hospitalier AVRANCHES-GRANVILLE

Avranches, France

Location

Centre Hospitalier Bayeux

Bayeux, France

Location

Centre François Baclesse

Caen, France

Location

CHU CAEN

Caen, France

Location

Hopital privé Paul d'Egine

Champigny-sur-Marne, France

Location

Centre Hospitalier de Cherbourg

Cherbourg-Octeville, France

Location

Ch Dieppe

Dieppe, France

Location

Centre Hospitalier de Flers

Flers, France

Location

Centre Oscar Lambret

Lille, France

Location

Centre Hospitalier Lisieux

Lisieux, France

Location

Hopital Européen Georges Pompidou (HEGP)

Paris, France

Location

Centre Hospitalier de Saint-lo

Saint-Lô, France

Location

Ghpso Senlis

Senlis, France

Location

IGR

Villejuif, France

Location

Related Publications (2)

• 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.

  PMID: 33215294 DERIVED

• 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.

  PMID: 31286871 DERIVED

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: December 18, 2017
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: October 6, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)