Clinical trial NCT03297723: Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management
Official title: Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2017-09-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient suffering from a cancer and suffering from pain

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.


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

Primary outcomes:
measure: 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).
timeFrame: 1 month
Secondary outcomes:
measure: The proportion of patients adhering to the full ETP program (3 workshops),
timeFrame: 1 month
Other outcomes:
Locations:
city: Alençon
country: France
facility: centre Hospitalier d'Alençon
city: Argentan
country: France
facility: Centre Hospitalier d'Argentan
city: Avranches
country: France
facility: Centre Hospitalier AVRANCHES-GRANVILLE
city: Bayeux
country: France
facility: Centre Hospitalier Bayeux
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU CAEN
city: Champigny-sur-Marne
country: France
facility: Hopital privé Paul d'Egine
city: Cherbourg-Octeville
country: France
facility: Centre Hospitalier de Cherbourg
city: Dieppe
country: France
facility: Ch Dieppe
city: Flers
country: France
facility: Centre Hospitalier de Flers
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lisieux
country: France
facility: Centre Hospitalier Lisieux
city: Paris
country: France
facility: Hopital Européen Georges Pompidou (HEGP)
city: Saint-Lô
country: France
facility: Centre Hospitalier de Saint-lo
city: Senlis
country: France
facility: Ghpso Senlis
city: Villejuif
country: France
facility: IGR
Study officials:
References:
citation: 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.
citation: 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.