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Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03297723
Acronym
EFFADOL-K
Enrollment
167
Registered
2017-09-29
Start date
2017-12-18
Completion date
2023-01-03
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Cancer

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.

Interventions

OTHERTherapeutic 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.

Sponsors

National Cancer Institute, France
CollaboratorOTHER_GOV
Centre Francois Baclesse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
The proportion of patients adhering to the full ETP program (3 workshops),1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026