Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

centre Hospitalier d'Alençon, Alençon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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 outcomes

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

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

National Cancer Institute, France

Registry information

Acronym: EFFADOL-K

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Sep 29, 2017
Registry last updated: Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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