Clinical trial NCT04634097: DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)
Official title: DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients With Cancer Pain
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group : Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).

Experimental group : 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life
timeFrame: 6 months
Secondary outcomes:
measure: Effectiveness of the intervention on other clinical outcomes
timeFrame: 6 months
measure: The organizational effectiveness of the intervention.
timeFrame: 6 months
measure: Educational effectiveness of the intervention.
timeFrame: 6 months
measure: Effectiveness of the intervention on patients value.
timeFrame: 6 months
measure: Efficiency of the intervention.
timeFrame: 6 months
measure: Effect of patient's caracteristics on the intervention effectiveness and participation.
timeFrame: 6 months
measure: Implementation of the intervention
timeFrame: 48 months
measure: Interaction between the contexts and the intervention effectiveness.
timeFrame: 48 months
measure: Mechanisms of action of the intervention.
timeFrame: 48 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest Paul Papin
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: GH Diaconesses Croix Saint Simon (GHDCSS)
city: Paris
country: France
facility: AP-HP La Pitié Salpêtrière
city: Saint-cloud
country: France
facility: Institut Curie
Study officials:
References: