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

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ClinicalTrials.gov Identifier: NCT03297723
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Francois Baclesse

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.


Condition or disease Intervention/treatment
Pain Cancer Other: Therapeutic education Programm

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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). [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. The proportion of patients adhering to the full ETP program (3 workshops), [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient suffering from a cancer and suffering from pain
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297723


Contacts
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Contact: Claire DELORME, MD 0231455050 c.delorme@baclesse.unicancer.fr
Contact: Virginie PREVOST, Pharm D 0231455050 virginie.prevost@unicaen.fr

Locations
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France
centre Hospitalier d'Alençon Recruiting
Alençon, France
Principal Investigator: Sonia CAUCHIN, MD         
Centre Hospitalier d'Argentan Recruiting
Argentan, France
Principal Investigator: Christine LE GAL, MD         
Centre Hospitalier AVRANCHES-GRANVILLE Recruiting
Avranches, France
Principal Investigator: Marie-Claude ROPARTZ, MD         
Centre Hospitalier Bayeux Recruiting
Bayeux, France
Principal Investigator: Claire DELORME, MD         
CHRU Brest-site de la Cavale Blanche Not yet recruiting
Brest, France
Contact: Claire BAZIRE, MD         
Principal Investigator: Claire BAZIRE, MD         
Centre François Baclesse Recruiting
Caen, France
Principal Investigator: Marie-Christine GRACH, MD         
CHU CAEN Recruiting
Caen, France
Contact: Marjorie LOAEC, MD         
Principal Investigator: Marjorie LOAEC, MD         
Centre Hospitalier de Cherbourg Recruiting
Cherbourg-Octeville, France
Principal Investigator: Laure KALUZINSKI, MD         
Centre Jean Perrin Recruiting
Clermont-ferrand, France
Contact: Christine VILLATTE, MD         
Ch Dieppe Not yet recruiting
Dieppe, France
Contact: Anne-Laure QUESNEL, MD         
Principal Investigator: Anne-Laure QUESNEL, MD         
Centre Hospitalier de Flers Recruiting
Flers, France
Principal Investigator: Franck LE CAER, MD         
Centre Oscar Lambret Recruiting
Lille, France
Contact: Nathalie LEROUX, MD         
Centre Hospitalier Lisieux Recruiting
Lisieux, France
Contact: Virith SEP HIENG, MD         
Principal Investigator: Virith SEP HIENG, MD         
Centre Hospitalier de Saint-lo Recruiting
Saint-Lô, France
Principal Investigator: Maryline FEUILLET, MD         
Ghpso Senlis Recruiting
Senlis, France
Contact: Gwladys FONTAINE, MD         
IGR Recruiting
Villejuif, France
Principal Investigator: Sophie LAURENT, MD         
Sponsors and Collaborators
Centre Francois Baclesse
National Cancer Institute, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03297723     History of Changes
Other Study ID Numbers: 2016-A01405-46
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No