Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management (EFFADOL-K)
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| ClinicalTrials.gov Identifier: NCT03297723 |
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Recruitment Status :
Recruiting
First Posted : September 29, 2017
Last Update Posted : October 1, 2019
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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 |
|---|---|
| Pain Cancer | Other: Therapeutic education Programm |
| Study Type : | Observational |
| Estimated Enrollment : | 260 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management |
| Actual Study Start Date : | December 18, 2017 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | December 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Therapeutic education Programm
Intervention will include:
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Controle arm
The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally.
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- 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 ]
- The proportion of patients adhering to the full ETP program (3 workshops), [ Time Frame: 1 month ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297723
| Contact: Claire DELORME, MD | 0231455050 | c.delorme@baclesse.unicancer.fr | |
| Contact: Virginie PREVOST, Pharm D | 0231455050 | virginie.prevost@unicaen.fr |
| France | |
| centre Hospitalier d'Alençon | Recruiting |
| Alençon, France | |
| Principal Investigator: Sonia CAUCHIN, MD | |
| Centre Hospitalier d'Argentan | Recruiting |
| Argentan, France | |
| Principal Investigator: Christine LE GAL, MD | |
| Centre Hospitalier AVRANCHES-GRANVILLE | Recruiting |
| Avranches, France | |
| Principal Investigator: Marie-Claude ROPARTZ, MD | |
| Centre Hospitalier Bayeux | Recruiting |
| Bayeux, France | |
| Principal Investigator: Claire DELORME, MD | |
| CHRU Brest-site de la Cavale Blanche | Not yet recruiting |
| Brest, France | |
| Contact: Claire BAZIRE, MD | |
| Principal Investigator: Claire BAZIRE, MD | |
| Centre François Baclesse | Recruiting |
| Caen, France | |
| Principal Investigator: Marie-Christine GRACH, MD | |
| CHU CAEN | Recruiting |
| Caen, France | |
| Contact: Marjorie LOAEC, MD | |
| Principal Investigator: Marjorie LOAEC, MD | |
| Centre Hospitalier de Cherbourg | Recruiting |
| Cherbourg-Octeville, France | |
| Principal Investigator: Laure KALUZINSKI, MD | |
| Centre Jean Perrin | Recruiting |
| Clermont-ferrand, France | |
| Contact: Christine VILLATTE, MD | |
| Ch Dieppe | Not yet recruiting |
| Dieppe, France | |
| Contact: Anne-Laure QUESNEL, MD | |
| Principal Investigator: Anne-Laure QUESNEL, MD | |
| Centre Hospitalier de Flers | Recruiting |
| Flers, France | |
| Principal Investigator: Franck LE CAER, MD | |
| Centre Oscar Lambret | Recruiting |
| Lille, France | |
| Contact: Nathalie LEROUX, MD | |
| Centre Hospitalier Lisieux | Recruiting |
| Lisieux, France | |
| Contact: Virith SEP HIENG, MD | |
| Principal Investigator: Virith SEP HIENG, MD | |
| Centre Hospitalier de Saint-lo | Recruiting |
| Saint-Lô, France | |
| Principal Investigator: Maryline FEUILLET, MD | |
| Ghpso Senlis | Recruiting |
| Senlis, France | |
| Contact: Gwladys FONTAINE, MD | |
| IGR | Recruiting |
| Villejuif, France | |
| Principal Investigator: Sophie LAURENT, MD | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre Francois Baclesse |
| ClinicalTrials.gov Identifier: | NCT03297723 History of Changes |
| Other Study ID Numbers: |
2016-A01405-46 |
| First Posted: | September 29, 2017 Key Record Dates |
| Last Update Posted: | October 1, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |