Cancer Patients With Cancer PainNCT04634097
DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)
A study testing Experimental group and standrad group in people with Cancer Patients With Cancer Pain, run by Institut Curie at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients With Cancer Pain
- What is being tested?
- Experimental group and standrad group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 5 sitesFrance
- Study dates
- 5 Mar 2021to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Institut de Cancérologie de l'Ouest Paul Papin
Angers, 49000
Institut Curie
Paris, 75005
GH Diaconesses Croix Saint Simon (GHDCSS)
Paris, 75012
AP-HP La Pitié Salpêtrière
Paris, 75013
Institut Curie
Saint-Cloud, 92210
About this study
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.
- Conditions
- Cancer Patients With Cancer Pain
- Being tested
- Experimental group, standrad group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Clusters will be proposed LE DECLIC EPRI intervention, which is a complex intervention, associating 3 components,:
- DECLIC program set up in the centers, open to concerned patients.
- 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.
- The collaboration of one primary care network, specialized in pain management, in order to reinforce the patient care pathway.
standrad groupOther
Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Experimental group |
| Standard group | Other | Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care). Receives: Other: standrad group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life
Brief pain Inventory BPI Questionnaire
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Efficiency of the intervention.
Cost-effectiveness analysis.
Measured: 6 months
Effect of patient's caracteristics on the intervention effectiveness and participation.
EDI quintile and Newest Vital Sign
Measured: 6 months
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.
Measured: 48 months
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.
Measured: 48 months
Mechanisms of action of the intervention.
Unexpected outcomes.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start5 Mar 2021
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients With Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634097
- Sponsor's protocol ID
- IC 2019-06
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)
- ClinicalTrials.gov ID
- NCT04634097
- Acronym / sponsor ID
- IC 2019-06
- Conditions
- Cancer Patients With Cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupClusters 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 group | Other | Other: standrad groupStandard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupClusters 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. | Other | Experimental group |
| standrad groupStandard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care). | Other | Standard group |
Primary outcome
Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life
Time frame: 6 months
Brief pain Inventory BPI Questionnaire
9 secondary outcomes
Effectiveness of the intervention on other clinical outcomes
Time frame: 6 months
The organizational effectiveness of the intervention.
Time frame: 6 months
Educational effectiveness of the intervention.
Time frame: 6 months
Effectiveness of the intervention on patients value.
Time frame: 6 months
Efficiency of the intervention.
Time frame: 6 months
Effect of patient's caracteristics on the intervention effectiveness and participation.
Time frame: 6 months
Implementation of the intervention
Time frame: 48 months
Interaction between the contexts and the intervention effectiveness.
Time frame: 48 months
Mechanisms of action of the intervention.
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group and standrad group in people with Cancer Patients With Cancer Pain, run by Institut Curie at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.