Back to resultsDECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)
Primary Purpose
Cancer Patients With Cancer Pain
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental group
standrad group
Sponsored by
About this trial
This is an interventional health services research trial for Cancer Patients With Cancer Pain
Eligibility Criteria
Inclusion Criteria:
- Patient aged over 18.
- Followed in the participant comprehensive cancer center.
- All cancer types, location and stage.
- Patient under any anticancer treatment (including hormonal therapy) or patient has stopped his treatment (including hormonal therapy) maximum 2 years before inclusion.
- Patient experiencing cancer pain and/or his treatments for 3 months or more.
- All previous and concomitant treatments are accepted.
- Participation to another clinical trial is accepted.
- Patient has accepted to participate to the study and signed informed consent form or his legal representative.
- Patient affiliated to the social security healthcare.
Exclusion Criteria:
- Cognitive impairment preventing to understand the patient education program.
- Language barrier preventing to understand the patient education program.
- Physical impairment preventing patient to attend to the patient education program.
Sites / Locations
- Institut de Cancérologie de l'Ouest Paul PapinRecruiting
- Institut CurieRecruiting
- GH Diaconesses Croix Saint Simon (GHDCSS)Recruiting
- AP-HP La Pitié SalpêtrièreRecruiting
- Institut CurieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
Standard group
Arm 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.
Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).
Outcomes
Primary Outcome Measures
Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life
Brief pain Inventory BPI Questionnaire
Secondary Outcome Measures
Effectiveness of the intervention on other clinical outcomes
Brief pain Inventory BPI, EQ-5D, DAMS questionnaires Other dimension of the QCD : current pain, average pain and worst pain in the last 24 hours.
Number of area identified as painfull by the patient, and surface of those area, measured on the "figures" item of the QCD.
Quality of life, assessed with the EQ-5D, in order to transform the results into utilities for the efficiency evaluation.
Side effects occurrence, related to the toxicity of the analgesics, assessed with a questionnaire constructed by the research team (questionnaires ad hoc).
Occurrence of atypical pain. Date of the occurrence of atypical pain. Occurrence of epiduritis. Date of the occurrence of epiduritis. Time between atypical pain occurrence and epiduritis diagnosis. Adhesion to analgesic medications assessed with a French translation of the questionnaire DAMS (Garfield et al), standardized per analgesic.
The organizational effectiveness of the intervention.
Organizational effectiveness Number of GPs recruited in the training sessions. Number of other primary care professionals recruited in the training sessions. Number of consultations with the GP by patient. Number of cancer pain consultations with the GP by patient. Number of consultation by patient due to pain with the GP. Number of interactions developed between the pain management network and GPs. Number of emergency consultations and hospitalisations due to pain by patient in the center.
Educational effectiveness of the intervention.
quiz with certitude level assessement, sure test, HADS questionnaires, French-Canadian Chronic Pain Self-efficacy Scale (FC-CPSES).
Knowledge, assessed with a quiz with certitude level assessement, developed specifically for the DECLIC program, by a multidisciplinary team of physicians, patients and reseachers.
Skills assessed with scenarii (simulated cases) developed specifically for the DECLIC program, by a multidisciplinary team of physicians, patients and reseachers. Informed decision assessed with a scenario (simulated case) developed specifically for the DECLIC program, by a multidisciplinary team of physicians, patients and reseachers. Informed decision is assessed with the French version of the SURE test. Anxiety : with the HADS questionnaire. Self efficacy, with French-Canadian Chronic Pain Self-efficacy Scale (FC-CPSES).
Sense of control with visual analogical scale. Ability to communicate with visual analogical scale developed specifically for the DECLIC program.
Effectiveness of the intervention on patients value.
D'Ivernois 2008 questionnaire, PAT-SAT 32 questionnaire, SMD Q9 questionnaire. Patient perceived quality of care will be assessed thanks to the medical consultation dimension of the PAT-SAT 32, a validated questionnaire in French.
Reported share decision making, inside GPs consultation, by patient. Share decision making assessed in the center with the with the SMD Q9, validated in French.
Efficiency of the intervention.
Cost-effectiveness analysis.
Effect of patient's caracteristics on the intervention effectiveness and participation.
EDI quintile and Newest Vital Sign
Implementation of the intervention
participation rate in the training of GPs and KLOs, number of GPs contacting the network, number of GPs contacting the patient education team, number of oncologists referring patients to the DECLIC program, number of patients referred by oncologist, number of oncologist consulting the patient education DECLIC e-record.
Reach :
number of patients who agreed to participate/number of patients to whom the study was proposed.
Reasons for refusal.
Interaction between the contexts and the intervention effectiveness.
Barriers and drivers to intervention adoption among KLOs and oncologists. Barriers and drivers to effective intervention in GPs. Barriers and drivers to effective intervention in patients.
Mechanisms of action of the intervention.
Unexpected outcomes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04634097
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
September 5, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Patients With Cancer Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm 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.
Arm Title
Standard group
Arm Type
Other
Arm Description
Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).
Intervention Type
Other
Intervention Name(s)
Experimental group
Intervention 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.
Intervention Type
Other
Intervention Name(s)
standrad group
Intervention Description
Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).
Primary Outcome Measure Information:
Title
Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life
Description
Brief pain Inventory BPI Questionnaire
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effectiveness of the intervention on other clinical outcomes
Description
Brief pain Inventory BPI, EQ-5D, DAMS questionnaires Other dimension of the QCD : current pain, average pain and worst pain in the last 24 hours.
Number of area identified as painfull by the patient, and surface of those area, measured on the "figures" item of the QCD.
Quality of life, assessed with the EQ-5D, in order to transform the results into utilities for the efficiency evaluation.
Side effects occurrence, related to the toxicity of the analgesics, assessed with a questionnaire constructed by the research team (questionnaires ad hoc).
Occurrence of atypical pain. Date of the occurrence of atypical pain. Occurrence of epiduritis. Date of the occurrence of epiduritis. Time between atypical pain occurrence and epiduritis diagnosis. Adhesion to analgesic medications assessed with a French translation of the questionnaire DAMS (Garfield et al), standardized per analgesic.
Time Frame
6 months
Title
The organizational effectiveness of the intervention.
Description
Organizational effectiveness Number of GPs recruited in the training sessions. Number of other primary care professionals recruited in the training sessions. Number of consultations with the GP by patient. Number of cancer pain consultations with the GP by patient. Number of consultation by patient due to pain with the GP. Number of interactions developed between the pain management network and GPs. Number of emergency consultations and hospitalisations due to pain by patient in the center.
Time Frame
6 months
Title
Educational effectiveness of the intervention.
Description
quiz with certitude level assessement, sure test, HADS questionnaires, French-Canadian Chronic Pain Self-efficacy Scale (FC-CPSES).
Knowledge, assessed with a quiz with certitude level assessement, developed specifically for the DECLIC program, by a multidisciplinary team of physicians, patients and reseachers.
Skills assessed with scenarii (simulated cases) developed specifically for the DECLIC program, by a multidisciplinary team of physicians, patients and reseachers. Informed decision assessed with a scenario (simulated case) developed specifically for the DECLIC program, by a multidisciplinary team of physicians, patients and reseachers. Informed decision is assessed with the French version of the SURE test. Anxiety : with the HADS questionnaire. Self efficacy, with French-Canadian Chronic Pain Self-efficacy Scale (FC-CPSES).
Sense of control with visual analogical scale. Ability to communicate with visual analogical scale developed specifically for the DECLIC program.
Time Frame
6 months
Title
Effectiveness of the intervention on patients value.
Description
D'Ivernois 2008 questionnaire, PAT-SAT 32 questionnaire, SMD Q9 questionnaire. Patient perceived quality of care will be assessed thanks to the medical consultation dimension of the PAT-SAT 32, a validated questionnaire in French.
Reported share decision making, inside GPs consultation, by patient. Share decision making assessed in the center with the with the SMD Q9, validated in French.
Time Frame
6 months
Title
Efficiency of the intervention.
Description
Cost-effectiveness analysis.
Time Frame
6 months
Title
Effect of patient's caracteristics on the intervention effectiveness and participation.
Description
EDI quintile and Newest Vital Sign
Time Frame
6 months
Title
Implementation of the intervention
Description
participation rate in the training of GPs and KLOs, number of GPs contacting the network, number of GPs contacting the patient education team, number of oncologists referring patients to the DECLIC program, number of patients referred by oncologist, number of oncologist consulting the patient education DECLIC e-record.
Reach :
number of patients who agreed to participate/number of patients to whom the study was proposed.
Reasons for refusal.
Time Frame
48 months
Title
Interaction between the contexts and the intervention effectiveness.
Description
Barriers and drivers to intervention adoption among KLOs and oncologists. Barriers and drivers to effective intervention in GPs. Barriers and drivers to effective intervention in patients.
Time Frame
48 months
Title
Mechanisms of action of the intervention.
Description
Unexpected outcomes.
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged over 18.
Followed in the participant comprehensive cancer center.
All cancer types, location and stage.
Patient under any anticancer treatment (including hormonal therapy) or patient has stopped his treatment (including hormonal therapy) maximum 2 years before inclusion.
Patient experiencing cancer pain and/or his treatments for 3 months or more.
All previous and concomitant treatments are accepted.
Participation to another clinical trial is accepted.
Patient has accepted to participate to the study and signed informed consent form or his legal representative.
Patient affiliated to the social security healthcare.
Exclusion Criteria:
Cognitive impairment preventing to understand the patient education program.
Language barrier preventing to understand the patient education program.
Physical impairment preventing patient to attend to the patient education program.
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina JUBIER-HAMON, MD
Phone
+33.2.41.35.27.00
Email
sabrina.jubier-hamon@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sabrina JUBIER-HAMON, MD
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyne RENAULT-TESSIER, MD
Phone
+33.1.44.32.40.40
Email
evelyne.renault-tessier@curie.fr
First Name & Middle Initial & Last Name & Degree
Anne-Sophie PLISSONNIER
Email
anne-sophie.plissonnier@curie.fr
First Name & Middle Initial & Last Name & Degree
Evelyne RENAULT-TESSIER, MD
Facility Name
GH Diaconesses Croix Saint Simon (GHDCSS)
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure COPEL, MD
Phone
+33.1.44.74.28.10
Email
lcopel@hpital-dcss.org
First Name & Middle Initial & Last Name & Degree
Laure COPEL, MD
Facility Name
AP-HP La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure SERRESSE, MD
Phone
+33.1.42.16.75.60
Email
laure.serresse@aphp.fr
First Name & Middle Initial & Last Name & Degree
Laure SERRESSE, MD
Facility Name
Institut Curie
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy BACRIE, MD
Phone
+33.1.47.11.15.15
Email
joy.bacrie@curie.fr
First Name & Middle Initial & Last Name & Degree
Anne-Sophie PLISSONNIER
Email
anne-sophie.plissonnier@curie.fr
First Name & Middle Initial & Last Name & Degree
Joy BACRIE, MD
12. IPD Sharing Statement
Learn more about this trial
DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)
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