Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management (EFFADOL-K)

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Cancer
• Intervention / Treatment: Other: Therapeutic education Programm

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

• Study Contact: Name: Claire DELORME, MD; Phone Number: 0231455050; Email: c.delorme@baclesse.unicancer.fr
• Study Contact Backup: Name: Virginie PREVOST, Pharm D; Phone Number: 0231455050; Email: virginie.prevost@unicaen.fr

Study Locations

• France
  • Alençon, France
    • Recruiting
    • centre Hospitalier d'Alençon
    • Principal Investigator: Sonia CAUCHIN, MD
  • Argentan, France
    • Recruiting
    • Centre Hospitalier d'Argentan
    • Principal Investigator: Christine LE GAL, MD
  • Avranches, France
    • Recruiting
    • Centre Hospitalier AVRANCHES-GRANVILLE
    • Principal Investigator: Marie-Claude ROPARTZ, MD
  • Bayeux, France
    • Recruiting
    • Centre Hospitalier Bayeux
    • Principal Investigator: Claire DELORME, MD
  • Caen, France
    • Recruiting
    • Centre Francois Baclesse
    • Principal Investigator: Marie-Christine GRACH, MD
  • Caen, France
    • Recruiting
    • CHU caen
    • Contact: Marjorie LOAEC, MD
    • Principal Investigator: Marjorie LOAEC, MD
  • Champigny-sur-Marne, France
    • Recruiting
    • Hopital Prive Paul d'Egine
    • Contact: Freddy KAYEMBE, MD
  • Cherbourg-Octeville, France
    • Recruiting
    • Centre Hospitalier de Cherbourg
  • Dieppe, France
    • Recruiting
    • CH Dieppe
    • Contact: Anne-Laure QUESNEL, MD
    • Principal Investigator: Anne-Laure QUESNEL, MD
  • Flers, France
    • Recruiting
    • Centre hospitalier de Flers
    • Principal Investigator: Franck LE CAER, MD
  • Lille, France
    • Completed
    • Centre Oscar Lambret
  • Lisieux, France
    • Recruiting
    • Centre Hospitalier Lisieux
    • Contact: Virith SEP HIENG, MD
    • Principal Investigator: Virith SEP HIENG, MD
  • Paris, France
    • Recruiting
    • Hôpital Européen Georges Pompidou (HEGP)
    • Contact: Alexandre SAADI, MD
  • Saint-Lô, France
    • Recruiting
    • Centre Hospitalier de Saint-Lo
    • Principal Investigator: Maryline FEUILLET, MD
  • Senlis, France
    • Recruiting
    • Ghpso Senlis
    • Contact: Gwladys FONTAINE, MD
  • Villejuif, France
    • Recruiting
    • IGR
    • Principal Investigator: Sophie LAURENT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient suffering from a cancer and suffering from pain

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: National Cancer Institute, France

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2017
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (ACTUAL): September 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A01405-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No