DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)

Institut Curie

Status: Completed

Conditions: Cancer Patients With Cancer Pain

Treatments: Other: Experimental group; Other: standrad group

Study type: Interventional

Funder types: Other

Identifiers

NCT04634097

IC 2019-06

Details and patient eligibility

About

Cancer pain is a frequent symptom, reported by 20 to 70% of patients in any stage of the cancer disease : 60 to 70% in the advanced stage of the disease and 20 to 40% among the survivors. Among patients who report pain, 40% report undertreated pain. Strengthening Pain management in cancer is a specific objective of the French Cancer Plan. Providing patient education for cancer pain management is recommended since small to moderate efficacy of patient education on pain intensity and interference was found in all meta-analysis. An effect size comparable with some analgesic agents. However, recommendations suggest improvement in order to increase effectiveness and population reach of those interventions. The DECLIC EPRI intervention aim at addressing all the issues raised by patient education for cancer pain management. It was developed according to the framework of Michie's Behavior change wheel theory.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient aged over 18.
2. Followed in the participant comprehensive cancer center.
3. All cancer types, location and stage.
4. Patient under any anticancer treatment (including hormonal therapy) or patient has stopped his treatment (including hormonal therapy) maximum 2 years before inclusion.
5. Patient experiencing cancer pain and/or his treatments for 3 months or more.
6. All previous and concomitant treatments are accepted.
7. Participation to another clinical trial is accepted.
8. Patient has accepted to participate to the study and signed informed consent form or his legal representative.
9. Patient affiliated to the social security healthcare.

Exclusion criteria

1. Cognitive impairment preventing to understand the patient education program.
2. Language barrier preventing to understand the patient education program.
3. Physical impairment preventing patient to attend to the patient education program.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Experimental group

Experimental group

Description:

Clusters will be proposed LE DECLIC EPRI intervention, which is a complex intervention, associating 3 components,: A. DECLIC program set up in the centers, open to concerned patients. B. 3 training sessions : * one public of primary care physicians in order to give them the opportunity to be involved in the medical care in charge of the patient suffering from cancer pain. * one public of cancer physicians, leaders of opinions in each cancer centers participating to the study and one public of health professionals in order to train them to be educators (team building). * for healthcare professionals in order to train them as educators in this program. C. The collaboration of one primary care network, specialized in pain management, in order to reinforce the patient care pathway.

Treatment:

Other: Experimental group

Standard group

Other group

Description:

Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).

Treatment:

Other: standrad group