Pain ManagementNCT02862002
Measuring the Effects of Therapeutic Education Program "Caratif" Patient Under Strong Opioids Versus Standard Taking Charge of Patient Pain Receiving Opioid Therapy in Medical Oncology.
A study testing therapeutic education of type "caratif in people with Pain Management, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
A first empirical evidence on the difficulties of observance of morphine in cancer patients invited a multidisciplinary team to initiate an innovative quality approach. It shows the lack of transcript of a comprehensive care causing a problem for monitoring actions undertaken for the relief of pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- therapeutic education of type "caratif
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Mar 2017
- 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
- Adult
- Cancer patients receiving opioids
- Suffering from pain caused by their disease or treatment with chemotherapy and / or radiotherapy and / or surgery
- Supported within the oncology or palliative care
- Receiving at least 3 courses of chemotherapy
- Having read, understood and signed the informed consent
- Subject beneficiary of a social security scheme or an equivalent -
Who cannot join
- adults subject to a legal protection measure or unable to consent
- Non-beneficiaries of a social security scheme,
- persons deprived of liberty by a judicial or administrative decision,
- patients with neurological or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille Hôpital de la Timone
Marseille, 13354
Florence DUFFAUD, 04.91.38.57.08 ext. +33, fduffaud@mail.ap-hm.fr
About this study
A first empirical evidence on the difficulties of observance of morphine in cancer patients invited a multidisciplinary team to initiate an innovative quality approach. It shows the lack of transcript of a comprehensive care causing a problem for monitoring actions undertaken for the relief of pain. In addition, two exploratory studies targeting the expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids.
The E.T.P, public health priority, provides a framework for action and improving care. In oncology, the involvement of the patient in pain relief and management of opioids represents an axis of intervention more appropriate. Yet, it is not found in literature. In our department, we conduct an experimental therapeutic education program type "caratif" and a nurse consultation FTE receiving opioids on the model of nursing "care" of J. Watson (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient experience). The ETP folder and its tools have been continuously validated with patients. The heart of the educational process is in the patient's complex path neat oncology and relies on interaction and creativity between patient and caregivers.
- Conditions
- Pain Management
- Being tested
- therapeutic education of type "caratif, Standard care
- Keywords
- opioid therapy, medical oncology.
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic education of type "caratifOther
study the effects of a therapeutic education program type "caratif", based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology
Standard careOther
patients receiving standard care of cancer pain.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Patient Education (E.T.P)of type "caratif | Experimental | Patients in arm E.T.P benefit of the nursing consultation E.T.P, Receives: Other: therapeutic education of type "caratif; Other: Standard care |
| standard care | Active comparator | patients receiving standard care of cancer pain. Receives: Other: therapeutic education of type "caratif; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Using a digital scale
Measured: 21 days
Secondary outcomes (4)
Treatment adherence morphine
Digital Scale / self-administered questionnaire of adherence of Girerd et al [78]
Measured: 21 days
Strategies Adjustment disease
Scale MAC (Mental Adjustment to Cancer Scale) French Version: Cayrou et al, 2001 [82]
Measured: 21 days
Anxiety
Scale HADS (Hospital anxiety and depression seale, French version: Sigmund and Snaith) [83]
Measured: 21 days
Depression
Scale HADS (Hospital anxiety and depression seale, French version: Sigmund and Snaith) [83]
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862002
- Sponsor's protocol ID
- RC12_3975 - 2756
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effects of Therapeutic Education Program "Caratif" Patient Under Strong Opioids Versus Standard Taking Charge of Patient Pain Receiving Opioid Therapy in Medical Oncology.
- ClinicalTrials.gov ID
- NCT02862002
- Acronym / sponsor ID
- RC12_3975 - 2756
- Conditions
- Pain Management
- Keywords
- opioid therapy, medical oncology.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- 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.
A first empirical evidence on the difficulties of observance of morphine in cancer patients invited a multidisciplinary team to initiate an innovative quality approach. It shows the lack of transcript of a comprehensive care causing a problem for monitoring actions undertaken for the relief of pain. In addition, two exploratory studies targeting the expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids.
The E.T.P, public health priority, provides a framework for action and improving care. In oncology, the involvement of the patient in pain relief and management of opioids represents an axis of intervention more appropriate. Yet, it is not found in literature. In our department, we conduct an experimental therapeutic education program type "caratif" and a nurse consultation FTE receiving opioids on the model of nursing "care" of J. Watson (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient experience). The ETP folder and its tools have been continuously validated with patients. The heart of the educational process is in the patient's complex path neat oncology and relies on interaction and creativity between patient and caregivers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Patient Education (E.T.P)of type "caratif | Experimental | Other: therapeutic education of type "caratif, Other: Standard carePatients in arm E.T.P benefit of the nursing consultation E.T.P, |
| standard care | Active comparator | Other: therapeutic education of type "caratif, Other: Standard carepatients receiving standard care of cancer pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult
- Cancer patients receiving opioids
- Suffering from pain caused by their disease or treatment with chemotherapy and / or radiotherapy and / or surgery
- Supported within the oncology or palliative care
- Receiving at least 3 courses of chemotherapy
Key exclusion criteria (4 listed)
- adults subject to a legal protection measure or unable to consent
- Non-beneficiaries of a social security scheme,
- persons deprived of liberty by a judicial or administrative decision,
- patients with neurological or psychiatric disorders
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 of type "caratifstudy the effects of a therapeutic education program type "caratif", based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology | Other | Therapeutic Patient Education (E.T.P)of type "caratif, standard care |
| Standard carepatients receiving standard care of cancer pain. | Other | Therapeutic Patient Education (E.T.P)of type "caratif, standard care |
Primary outcome
Pain assessment
Time frame: 21 days
Using a digital scale
4 secondary outcomes
Treatment adherence morphine
Time frame: 21 days
Strategies Adjustment disease
Time frame: 21 days
Anxiety
Time frame: 21 days
Depression
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic education of type "caratif in people with Pain Management, run by Assistance Publique Hopitaux De Marseille at 1 site 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence DUFFAUD (04.91.38.57.08, fduffaud@mail.ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 21 days). 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 10 Aug 2016.