Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Last updated: May 17, 2021
Sponsor: Centre Francois Baclesse
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03297723
2016-A01405-46
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient suffering from a cancer which diagnosis has been established since at least 1month
  • 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 greaterthan 4 (on a 0-10 numerical rating scale), OR pain leading to insomnia OR 4 dailybreakthrough 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

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

Total Participants: 220
Study Start date:
December 18, 2017
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Centre Hospitalier AIX LES BAINS

    AIX les BAINS,
    France

    Site Not Available

  • centre Hospitalier d'Alençon

    Alençon,
    France

    Active - Recruiting

  • Centre Hospitalier d'Argentan

    Argentan,
    France

    Active - Recruiting

  • Centre Hospitalier AVRANCHES-GRANVILLE

    Avranches,
    France

    Active - Recruiting

  • Centre Hospitalier Bayeux

    Bayeux,
    France

    Active - Recruiting

  • CHRU Brest-site de la Cavale Blanche

    Brest,
    France

    Site Not Available

  • CHU CAEN

    Caen,
    France

    Active - Recruiting

  • Centre François Baclesse

    Caen,
    France

    Active - Recruiting

  • Hopital privé Paul d'Egine

    Champigny-sur-Marne,
    France

    Active - Recruiting

  • Centre Hospitalier de Cherbourg

    Cherbourg-Octeville,
    France

    Active - Recruiting

  • Centre Jean Perrin

    Clermont-ferrand,
    France

    Site Not Available

  • Ch Dieppe

    Dieppe,
    France

    Active - Recruiting

  • Centre Hospitalier de Flers

    Flers,
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille,
    France

    Completed

  • Centre Hospitalier Lisieux

    Lisieux,
    France

    Active - Recruiting

  • Hopital Européen Georges Pompidou (HEGP)

    Paris,
    France

    Active - Recruiting

  • Centre Hospitalier de Saint-lo

    Saint-Lô,
    France

    Active - Recruiting

  • CHU St ETIENNE

    Saint-Étienne,
    France

    Site Not Available

  • Ghpso Senlis

    Senlis,
    France

    Active - Recruiting

  • Centre Hospitalier de Versailles

    Versailles,
    France

    Site Not Available

  • IGR

    Villejuif,
    France

    Active - Recruiting

  • Centre Hospitalier VOIRON

    Voiron,
    France

    Site Not Available

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