Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial.
Pain cancer
Pain management
Patient education
Quality of life
Stepped-wedge randomised controlled trial
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
08 Jul 2019
08 Jul 2019
Historique:
received:
12
04
2019
accepted:
14
06
2019
entrez:
10
7
2019
pubmed:
10
7
2019
medline:
18
12
2019
Statut:
epublish
Résumé
Despite numerous guidelines, nearly one of two patients with cancer pain remains undertreated, thereby affecting their quality of life. Active patient involvement through Therapeutic Patient Education (TPE) is considered as a relevant strategy to overcoming hurdles in pain management. The aim of the EFFADOL study is to assess the effectiveness of a TPE program in improving cancer pain management. The EFFADOL study is a stepped-wedge randomised controlled trial. A total of 260 cancer patients with unbalanced background pain will be randomised over the institutional level, i.e. stepped-wedge cluster design. Six clusters will be formed, one at the regional level of "Basse-Normandie" for patients receiving the educational approach by health providers already trained to TPE. Then, five additional centers will be gradually included at the national level, making it possible to compare the "conventional" management of pain (before medical staff training to TPE) with the educational approach (after being trained). The main study parameter is pain interference on daily life assessed with the self-administrated and validated Brief Pain Inventory questionnaire. Secondary objectives comprised the evaluation of patients' adherence to pain education program, the description of pain intensity, pain relief, analgesic adherence and pain emotional impact. Educational dimension of the program will be evaluated through the patients' acquisition of knowledge and skills about their pain and treatment as well as their self-efficacy to participate actively in pain management. The patient's feeling of pain changes will be measured. Finally, the satisfaction of participants and educators will be reported. We hypothetise active involvement of patients in TPE will lead to an improved pain management compared to standard care. Analyzing the impact of a TPE program in cancer pain patients will improve their pain management and quality of life. We expect that the dissemination of our project educational approach through the French territory will be accompanied by long term change in clinical practices with mutual benefit to patients and caregiver-educators. NCT03297723 , registered: 09/28/2017. Protocol version: Version n°1.1 dated from 2016/09/08.
Sections du résumé
BACKGROUND
BACKGROUND
Despite numerous guidelines, nearly one of two patients with cancer pain remains undertreated, thereby affecting their quality of life. Active patient involvement through Therapeutic Patient Education (TPE) is considered as a relevant strategy to overcoming hurdles in pain management. The aim of the EFFADOL study is to assess the effectiveness of a TPE program in improving cancer pain management.
METHODS/DESIGN
METHODS
The EFFADOL study is a stepped-wedge randomised controlled trial. A total of 260 cancer patients with unbalanced background pain will be randomised over the institutional level, i.e. stepped-wedge cluster design. Six clusters will be formed, one at the regional level of "Basse-Normandie" for patients receiving the educational approach by health providers already trained to TPE. Then, five additional centers will be gradually included at the national level, making it possible to compare the "conventional" management of pain (before medical staff training to TPE) with the educational approach (after being trained). The main study parameter is pain interference on daily life assessed with the self-administrated and validated Brief Pain Inventory questionnaire. Secondary objectives comprised the evaluation of patients' adherence to pain education program, the description of pain intensity, pain relief, analgesic adherence and pain emotional impact. Educational dimension of the program will be evaluated through the patients' acquisition of knowledge and skills about their pain and treatment as well as their self-efficacy to participate actively in pain management. The patient's feeling of pain changes will be measured. Finally, the satisfaction of participants and educators will be reported. We hypothetise active involvement of patients in TPE will lead to an improved pain management compared to standard care.
DISCUSSION
CONCLUSIONS
Analyzing the impact of a TPE program in cancer pain patients will improve their pain management and quality of life. We expect that the dissemination of our project educational approach through the French territory will be accompanied by long term change in clinical practices with mutual benefit to patients and caregiver-educators.
TRIAL REGISTRATION
BACKGROUND
NCT03297723 , registered: 09/28/2017. Protocol version: Version n°1.1 dated from 2016/09/08.
Identifiants
pubmed: 31286871
doi: 10.1186/s12885-019-5836-5
pii: 10.1186/s12885-019-5836-5
pmc: PMC6615097
doi:
Banques de données
ClinicalTrials.gov
['NCT03297723']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
673Subventions
Organisme : French Cancer Institute (INCa)
ID : RISP15-007_FP / INCA_10187
Références
JAMA. 1999 Sep 22-29;282(12):1157-62
pubmed: 10501119
Pain. 1992 Jul;50(1):59-65
pubmed: 1513604
Pain. 2005 Jan;113(1-2):9-19
pubmed: 15621359
Contemp Clin Trials. 2007 Feb;28(2):182-91
pubmed: 16829207
J Pain. 2008 Feb;9(2):105-21
pubmed: 18055266
Ann Oncol. 2008 Dec;19(12):1985-91
pubmed: 18632721
Pain. 2009 Jun;143(3):192-9
pubmed: 19285376
Patient Educ Couns. 2010 Jul;80(1):42-7
pubmed: 19962845
J Pain Symptom Manage. 2010 Sep;40(3):327-41
pubmed: 20580201
Asian Pac J Cancer Prev. 2010;11 Suppl 1:7-12
pubmed: 20590341
J Pain Symptom Manage. 2011 May;41(5):915-39
pubmed: 21398088
J Clin Epidemiol. 2011 Sep;64(9):936-48
pubmed: 21411284
Eur J Cancer. 2012 Apr;48(6):904-11
pubmed: 22033328
Cancer. 2013 Feb 15;119(4):832-8
pubmed: 22951813
Br J Psychiatry. 1990 Jan;156:79-83
pubmed: 2297623
Support Care Cancer. 2013 Jul;21(7):1963-71
pubmed: 23430013
BMC Public Health. 2013 Nov 21;13:1088
pubmed: 24261985
J Clin Oncol. 2014 Jun 1;32(16):1662-70
pubmed: 24799466
J Clin Oncol. 2014 Jun 1;32(16):1727-33
pubmed: 24799490
J Clin Oncol. 2014 Dec 20;32(36):4149-54
pubmed: 25403222
Patient Educ Couns. 2015 Mar;98(3):269-82
pubmed: 25483575
BMJ. 2015 Feb 06;350:h391
pubmed: 25662947
Am J Hosp Palliat Care. 2016 Jul;33(6):599-612
pubmed: 25991567
J Pain Symptom Manage. 2016 Jun;51(6):1070-1090.e9
pubmed: 27112310
Support Care Cancer. 2017 Apr;25(4):1323-1355
pubmed: 28058570
Support Care Cancer. 2017 Nov;25(11):3595-3602
pubmed: 28653107
J Cancer Educ. 2018 Dec;33(6):1355-1361
pubmed: 28804809
Cancer Treat Rev. 2018 Feb;63:96-103
pubmed: 29272781
J Pain Res. 2019 Jun 06;12:1813-1823
pubmed: 31239759
Pain. 1993 Mar;52(3):319-24
pubmed: 7681557
BMJ. 1995 Apr 22;310(6986):1034-7
pubmed: 7728056
Ann Acad Med Singapore. 1994 Mar;23(2):129-38
pubmed: 8080219