EFFADOL-K: Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: Therapeutic education Programm
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.
|
| Controle arm The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally. |
Outcome Measures
Primary Outcome Measures
- 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). [1 month]
Secondary Outcome Measures
- The proportion of patients adhering to the full ETP program (3 workshops), [1 month]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient suffering from a cancer which diagnosis has been established since at least 1 month
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Patient who suffers from pain related to the pathology or its treatment:
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receiving an analgesic treatment since at least 1 month
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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
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Patient with a life expectancy > or = 6 months
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Health compatible with the PEP requirements (WHO performance scale > or = 2)
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Patient v 18 years old
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Patient able to understand, speak and read French
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Patient without cognitive dysfunctions
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Patient with a signed informed consent before inclusion in the study
Exclusion Criteria:
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Primary central nervous system or cerebral metastases
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Disorders of higher functions documented
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Evolutionary psychiatric pathology
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Drug user
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Abuse of alcohol exceeding WHO recommendations
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Refusal of participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | centre Hospitalier d'Alençon | Alençon | France | ||
| 2 | Centre Hospitalier d'Argentan | Argentan | France | ||
| 3 | Centre Hospitalier AVRANCHES-GRANVILLE | Avranches | France | ||
| 4 | Centre Hospitalier Bayeux | Bayeux | France | ||
| 5 | Centre François Baclesse | Caen | France | ||
| 6 | CHU CAEN | Caen | France | ||
| 7 | Hopital privé Paul d'Egine | Champigny-sur-Marne | France | ||
| 8 | Centre Hospitalier de Cherbourg | Cherbourg-Octeville | France | ||
| 9 | Ch Dieppe | Dieppe | France | ||
| 10 | Centre Hospitalier de Flers | Flers | France | ||
| 11 | Centre Oscar Lambret | Lille | France | ||
| 12 | Centre Hospitalier Lisieux | Lisieux | France | ||
| 13 | Hopital Européen Georges Pompidou (HEGP) | Paris | France | ||
| 14 | Centre Hospitalier de Saint-lo | Saint-Lô | France | ||
| 15 | Ghpso Senlis | Senlis | France | ||
| 16 | IGR | Villejuif | France |
Sponsors and Collaborators
- Centre Francois Baclesse
- National Cancer Institute, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-A01405-46