Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial

Virginie Prevost, Natacha Heutte, Alexandra Leconte, Idlir Licaj, Claire Delorme, Bénédicte Clarisse, EFFADOL-Group, Virginie Prevost, Natacha Heutte, Alexandra Leconte, Idlir Licaj, Claire Delorme, Bénédicte Clarisse, EFFADOL-Group

Abstract

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: 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: 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: NCT03297723 , registered: 09/28/2017. Protocol version: Version n°1.1 dated from 2016/09/08.

Keywords: Pain cancer; Pain management; Patient education; Quality of life; Stepped-wedge randomised controlled trial.

Conflict of interest statement

Not applicable.

Figures

Fig. 1
Fig. 1
Schematic representation of the stepped-wedge design
Fig. 2
Fig. 2
Study flowchart. Abbreviations: PEP Pain Education Program
Fig. 3
Fig. 3
Expected distribution of patients according to the stepped-wedge design

References

    1. Portenoy RK, Ahmed E. Principles of opioid use in cancer pain. J Clin Oncol. 2014;32:1662–1670. doi: 10.1200/JCO.2013.52.5188.
    1. Van den Beuken-van Everdingen MHJ, Hochstenbach LMJ, Joosten EAJ, Tjan-Heijnen VCG, Janssen DJA. Update on prevalence of pain in patients with Cancer: systematic review and meta-analysis. J Pain Symptom Manag. 2016;51:1070–1090. doi: 10.1016/j.jpainsymman.2015.12.340.
    1. Kroenke K, Theobald D, Wu J, Loza JK, Carpenter JS, Tu W. The association of depression and pain with health-related quality of life, disability, and health care use in cancer patients. J Pain Symptom Manag. 2010;40:327–341. doi: 10.1016/j.jpainsymman.2009.12.023.
    1. Greco MT, Roberto A, Corli O, Deandrea S, Bandieri E, Cavuto S, et al. Quality of cancer pain management: an update of a systematic review of undertreatment of patients with cancer. J Clin Oncol. 2014;32:4149–4154. doi: 10.1200/JCO.2014.56.0383.
    1. Ward SE, Goldberg N, Miller-McCauley V, Mueller C, Nolan A, Pawlik-Plank D, et al. Patient-related barriers to management of cancer pain. Pain. 1993;52:319–324. doi: 10.1016/0304-3959(93)90165-L.
    1. Brant JM. The global experience of cancer pain. Asian Pac J Cancer Prev. 2010;11(Suppl 1):7–12.
    1. Kwon JH. Overcoming barriers in cancer pain management. J Clin Oncol. 2014;32:1727–1733. doi: 10.1200/JCO.2013.52.4827.
    1. World Health Organization. Regional Office for Europe (1998) Therapeutic patient education: continuing education programmes for health care providers in the field of prevention of chronic diseases: report of a WHO working group. Copenhagen: WHO Regional Office for Europe. []. Accessed 20 June 2019.
    1. Prevost V, Delorme C, Grach MC, Chvetzoff G, Hureau M. Therapeutic education in improving Cancer pain management: a synthesis of available studies. Am J Hosp Palliat Care. 2016;33:599–612. doi: 10.1177/1049909115586394.
    1. Oldenmenger WH, Gearing JI, Mostovaya I, Vissers KCP, de Graeff A, Reyners AKL, et al. A systematic review of the effectiveness of patient-based educational interventions to improve cancer-related pain. Cancer Treat Rev. 2018;63:96–103. doi: 10.1016/j.ctrv.2017.12.005.
    1. Adam R, Bond C, Murchie P. Educational interventions for cancer pain. A systematic review of systematic reviews with nested narrative review of randomized controlled trials. Patient Educ Couns. 2015;98:269–282. doi: 10.1016/j.pec.2014.11.003.
    1. Bennett MI, Bagnall AM, José Closs S. How effective are patient-based educational interventions in the management of cancer pain? Pain. 2009;143:192–199. doi: 10.1016/j.pain.2009.01.016.
    1. Cummings GG, Olivo SA, Biondo PD, Stiles CR, Yurtseven O, Fainsinger RL, et al. Effectiveness of knowledge translation interventions to improve cancer pain management. J Pain Symptom Manag. 2011;41:915–939. doi: 10.1016/j.jpainsymman.2010.07.017.
    1. Jho HJ, Myung SK, Chang YJ, Kim DH, Ko DH. Efficacy of pain education in cancer patients: a meta-analysis of randomized controlled trials. Support Care Cancer. 2013;21:1963–1971. doi: 10.1007/s00520-013-1756-0.
    1. Prevost V, Clarisse B, Heutte N, Leconte A, Bisson C, Bignon R, et al. Therapeutic patient education in Cancer pain management: from practice to research: proposals and strategy of the French EFFADOL program. J Cancer Educ. 2018;33:1355–1361. doi: 10.1007/s13187-017-1258-8.
    1. Prevost V, Delorme C, Heutte N, Leconte A, Bechet C, Licaj I, Bignon R, Bisson C, Cauchin S, Gicquère M, Grach MC, Guillaumé C, Le Garrec J, Ropartz MC, Roux N, Sep Hieng V, Le Chevalier A, Clarisse B. Evaluation of patients’ needs to design and assess a patient education program in cancer pain. J Pain Res. 2019;12:1813–23.
    1. Rasmussen CD, Holtermann A, Mortensen OS, Søgaard K, Jørgensen MB. Prevention of low back pain and its consequences among nurses' aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial. BMC Public Health. 2013;13:1088. doi: 10.1186/1471-2458-13-1088.
    1. Hussey MA, Hughes JP. Cluster randomized crossover trials: design and analysis of the stepped wedge design. Contemp Clin Trials. 2007;28:182–191. doi: 10.1016/j.cct.2006.05.007.
    1. Mdege ND, Man MS, Taylor CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011;64:936–948. doi: 10.1016/j.jclinepi.2010.12.003.
    1. Poulain P, Michenot N, Ammar D, Delorme C, Delorme T, Diquet B, et al. Mise au point sur l’utilisation du fentanyl transmuqueux chez le patient présentant des douleurs d’origine cancéreuse (version longue) Doul et Analg. 2012;25:102–117. doi: 10.1007/s11724-012-0287-7.
    1. Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singap. 1994;13:129–138.
    1. Larue F, Colleau SM, Brasseur L, Cleeland CS. Multicentre study of cancer pain and its treatment in France. BMJ. 1995;310:1034–1037. doi: 10.1136/bmj.310.6986.1034.
    1. ANAES, Evaluation et suivi de la douleur chronique chez l’adulte en médecine ambulatoire, Service des Recommandations et Références professionnelles, février 1999. []. Accessed 20 June 2019.
    1. Zelman D. C., Cleeland C. S., Howland E. W. Factors in appropriate pharmacological management of cancer pain: A cross-institutional investigation. Pain. 1987;30:S136. doi: 10.1016/0304-3959(87)91344-3.
    1. Razavi D, Delvaux N, Farvacques C, Robaye E. Screening for adjustment disorders and major depressive disorders in cancer in-patients. Br J Psychiatry. 1990;156:79–83. doi: 10.1192/bjp.156.1.79.
    1. Boureau F, Luu M, Doubrère JF. Comparative study of the validity of four French McGill pain questionnaire (MPQ) versions. Pain. 1992;50:59–65. doi: 10.1016/0304-3959(92)90112-O.
    1. Marquié L, Duarte L-R, Mauriès V, Izard P, Pouymayou J. Les caractéristiques psychométriques du Questionnaire de douleur de Saint-Antoine en consultation d’algologie chez les personnes atteintes de cancer. Doul et Analg. 2008;21:52–61. doi: 10.1007/s11724-008-0083-6.
    1. Street RL, Jr, Slee C, Kalauokalani DK, Dean DE, Tancredi DJ, Kravitz RL. Improving physician-patient communication about cancer pain with a tailored education-coaching intervention. Patient Educ Couns. 2010;80:42–47. doi: 10.1016/j.pec.2009.10.009.
    1. Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H. Capturing the patient’s view of change as a clinical outcome measure. JAMA. 1999;282:1157–1162. doi: 10.1001/jama.282.12.1157.
    1. PLANETH Patient (Plateforme Normande d'Education Thérapeutique du Patient). Evaluation quadriennale. []. Accessed 20 June 2019.
    1. Minaya P, Baumstarck K, Berbis J, Goncalves A, Barlesi F, Michel G, et al. The CareGiver oncology quality of life questionnaire (CarGOQoL): development and validation of an instrument to measure the quality of life of the caregivers of patients with cancer. Eur J Cancer. 2012;48:904–911. doi: 10.1016/j.ejca.2011.09.010.
    1. Cleeland CS, Body JJ, Stopeck A, von Moos R, Fallowfield L, Mathias SD, et al. Pain outcomes in patients with advanced breast cancer and bone metastases: results from a randomized, double-blind study of denosumab and zoledronic acid. Cancer. 2013;119:832–838. doi: 10.1002/cncr.27789.
    1. IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials). []. Accessed 20 June 2019.
    1. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19. doi: 10.1016/j.pain.2004.09.012.
    1. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105–121. doi: 10.1016/j.jpain.2007.09.005.
    1. Deandrea S, Montanari M, Moja L, Apolone G. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol. 2008;19:1985–1991. doi: 10.1093/annonc/mdn419.
    1. Gunnarsdottir S, Sigurdardottir V, Kloke M, Radbruch L, Sabatowski R, Kaasa S, et al. A multicenter study of attitudinal barriers to cancer pain management. Support Care Cancer. 2017;25:3595–3602. doi: 10.1007/s00520-017-3791-8.
    1. Howell D, Harth T, Brown J, Bennett C, Boyko S. Self-management education interventions for patients with cancer: a systematic review. Support Care Cancer. 2017;25:1323–1355. doi: 10.1007/s00520-016-3500-z.
    1. Institut National du Cancer- Plan cancer 2014-2019 : priorités et objectifs []. Accessed 20 June 2019.
    1. Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391. doi: 10.1136/bmj.h391.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi