Pain CancerEFFADOL-KNCT03297723
Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management
An observational study of Pain Cancer, run by Centre Francois Baclesse at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Cancer
- What is being tested?
- Therapeutic education Programm
- How many people
- 167 participants
- Where
- 16 sitesFrance
- Study dates
- 18 Dec 2017to 3 Jan 2023
- Phase
- Observational
- 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
Study population: Patient suffering from a cancer and suffering from pain
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
centre Hospitalier d'Alençon
Alençon
Centre Hospitalier d'Argentan
Argentan
Centre Hospitalier AVRANCHES-GRANVILLE
Avranches
Centre Hospitalier Bayeux
Bayeux
Centre François Baclesse
Caen
CHU CAEN
Caen
Hopital privé Paul d'Egine
Champigny-sur-Marne
Centre Hospitalier de Cherbourg
Cherbourg-Octeville
Ch Dieppe
Dieppe
Centre Hospitalier de Flers
Flers
Centre Oscar Lambret
Lille
Centre Hospitalier Lisieux
Lisieux
Hopital Européen Georges Pompidou (HEGP)
Paris
Centre Hospitalier de Saint-lo
Saint-Lô
Ghpso Senlis
Senlis
IGR
Villejuif
About this study
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.
- Conditions
- Pain Cancer
- Being tested
- Therapeutic education Programm
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic education ProgrammOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | The experimental group will be constituted after the medical staff was trained to TPE. Cancer patients will benefit from a PEP aiming at learning how to better manage their pain. Receives: Other: Therapeutic education Programm | |
| Controle arm | The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Secondary outcomes (1)
The proportion of patients adhering to the full ETP program (3 workshops),
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start18 Dec 2017
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297723
- Sponsor's protocol ID
- 2016-A01405-46
- Acronym
- EFFADOL-K
- Status last verified
- Jul 2023
- First submitted
- 26 Sep 2017
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prevost V, Christy F, Quesnel AL, Le Goff G, Gicquere M, Mezaib K, Kayembe F, Saadi A, Leroux-Bromberg N, Leconte A, Clarisse B. Effectiveness of a pain education programme in cancer pain management: Results from the EFFADOL stepped-wedge trial. Patient Educ Couns. 2026 Jul 30;152:109799. doi: 10.1016/j.pec.2026.109799. Online ahead of print.
PubMed 42551208Prevost V, Delorme C, Leconte A, Le Chevalier A, Fourel L, Gicquere M, Grach MC, Le Caer F, Clarisse B. Cancer Pain and Patient Education: Strategy, Implementation, Difficulties and Opportunities of EFFADOL, a Regional Collaborative Programme. J Cancer Educ. 2022 Aug;37(4):1089-1098. doi: 10.1007/s13187-020-01924-w. Epub 2020 Nov 19.
PubMed 33215294Prevost V, Heutte N, Leconte A, Licaj I, Delorme C, Clarisse B; EFFADOL-Group. Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial. BMC Cancer. 2019 Jul 8;19(1):673. doi: 10.1186/s12885-019-5836-5.
PubMed 31286871
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management
- ClinicalTrials.gov ID
- NCT03297723
- Acronym / sponsor ID
- EFFADOL-K / 2016-A01405-46
- Conditions
- Pain Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 29 Sep 2017 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | – | Other: Therapeutic education ProgrammThe experimental group will be constituted after the medical staff was trained to TPE. Cancer patients will benefit from a PEP aiming at learning how to better manage their pain. |
| Controle arm | – | –The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient suffering from a cancer and suffering from pain
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- Primary central nervous system or cerebral metastases
- Disorders of higher functions documented
- Evolutionary psychiatric pathology
- Drug user
- Abuse of alcohol exceeding WHO recommendations
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 |
|---|---|---|
| Therapeutic education ProgrammIntervention 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. | Other | Experimental arm |
Primary outcome
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).
Time frame: 1 month
1 secondary outcome
The proportion of patients adhering to the full ETP program (3 workshops),
Time frame: 1 month
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 6 Oct 2025.
- Derived from this study: PubMed 42551208Prevost V, Christy F, Quesnel AL, Le Goff G, Gicquere M, Mezaib K, Kayembe F, Saadi A, Leroux-Bromberg N, Leconte A, Clarisse B. Effectiveness of a pain education programme in cancer pain management: Results from the EFFADOL stepped-wedge trial. Patient Educ Couns. 2026 Jul 30;152:109799. doi: 10.1016/j.pec.2026.109799. Online ahead of print.
- Derived from this study: PubMed 33215294Prevost V, Delorme C, Leconte A, Le Chevalier A, Fourel L, Gicquere M, Grach MC, Le Caer F, Clarisse B. Cancer Pain and Patient Education: Strategy, Implementation, Difficulties and Opportunities of EFFADOL, a Regional Collaborative Programme. J Cancer Educ. 2022 Aug;37(4):1089-1098. doi: 10.1007/s13187-020-01924-w. Epub 2020 Nov 19.
- Derived from this study: PubMed 31286871Prevost V, Heutte N, Leconte A, Licaj I, Delorme C, Clarisse B; EFFADOL-Group. Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial. BMC Cancer. 2019 Jul 8;19(1):673. doi: 10.1186/s12885-019-5836-5.
- Individual participant dataSharing planned: No
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Cancer, run by Centre Francois Baclesse at 16 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 10 inclusion and 6 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
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). (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297723, which also lists 3 linked publications.
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 6 Oct 2025.