OJN  Vol.4 No.2 , February 2014
Testing the feasibility and effects of a self-management support intervention for patients with cancer and their family caregivers to reduce pain and related symptoms (ANtiPain): Study protocol of a pilot study
Abstract: Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self? Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an in-hospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures; 2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation; 3) to explore participants’ experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.
Cite this paper: Koller, A. , Hasemann, M. , Jaroslawski, K. , Geest, S. and Becker, G. (2014) Testing the feasibility and effects of a self-management support intervention for patients with cancer and their family caregivers to reduce pain and related symptoms (ANtiPain): Study protocol of a pilot study. Open Journal of Nursing, 4, 85-94. doi: 10.4236/ojn.2014.42012.

[1]   Van den Beuken-van Everdingen, M.H., de Rijke, J.M., Kessels, A.G., Schouten, H.C., van Kleef, M. and Patijn, J. (2007) Prevalence of pain in patients with cancer: A systematic review of the past 40 years. Annals of Oncology, 18, 1437-1449.

[2]   Mercadante, S. (2007) Why are our patients still suffering pain? Nature Clinical Practice Oncology, 4, 138-139.

[3]   Breivik, H., Cherny, N., Collett, B., de Conno, F., Filbet, M., Foubert, A.J., Cohen, R. and Dow, L. (2009) Cancerrelated pain: A pan-European survey of prevalence, treatment, and patient attitudes. Annals of Oncology, 20, 1420-1433.

[4]   Jacobsen, R., Liubarskiene, Z., Moldrup, C., Christrup, L., Sjogren, P. and Samsanaviciene, J. (2009) Barriers to cancer pain management: A review of empirical research. Medicina (Kaunas), 45, 427-433.

[5]   Allard, P., Maunsell, E., Labbe, J. and Dorval, M. (2001) Educational interventions to improve cancer pain control: A systematic review. Journal of Palliative Medicine, 4, 191-203.

[6]   Bennett, M.I., Bagnall, A.M. and Closs, S.J. (2009) How effective are patient-based educational interventions in the management of cancer pain? Systematic review and meta-analysis. Pain, 143, 192-199.

[7]   Devine, E.C. (2003) Meta-analysis of the effect of psychoeducational interventions on pain in adults with cancer. Oncology Nursing Forum, 30, 75-89.

[8]   Koller, A., Miaskowski, C., De Geest, S., Opitz, O. and Spichiger, E. (2013) A systematic evaluation of content, structure, and efficacy of interventions to improve patients’ self-management of cancer pain. Journal of Pain and Symptom Management, 44, 264-284.

[9]   Miaskowski, C., Dodd, M., West, C., Schumacher, K., Paul, S.M., Tripathy, D. and Koo, P. (2004) Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. Journal of Clinical Oncology, 22, 1713-1720.

[10]   Miaskowski, C., Dodd, M., West, C., Paul, S.M., Schumacher, K., Tripathy, D. and Koo, P. (2007) The use of a responder analysis to identify differences in patient outcomes following a self-care intervention to improve cancer pain management. Pain, 129, 55-63.

[11]   Schumacher, K.L., Koresawa, S., West, C., Hawkins, C., Johnson, C., Wais, E., Dodd, M., Paul, S.M., Tripathy, D., Koo, P. and Miaskowski, C. (2002) Putting cancer pain management regimens into practice at home. Journal of Pain and Symptom Management, 23, 369-382.

[12]   Koller, A., Miaskowski, C., De Geest, S., Opitz, O. and Spichiger, E. (2013) Results of a randomized controlled pilot study of a self-management intervention for cancer pain. European Journal of Oncology Nursing, 17, 284-291.

[13]   Koller, A., Miaskowski, C., De Geest, S., Opitz, O. and Spichiger, E. (2013) Supporting self-management of pain in cancer patients: Methods and lessons learned from a randomized controlled pilot study. European Journal of Oncology Nursing, 17, 1-8.

[14]   Koller, A., Miaskowski, C., De Geest, S., Opitz, O. and Spichiger, E. (2012) Testing of an intervention to support pain self-management in oncology patients: A mixed methods pilot study. Pflege: Die wissenschaftliche Zeitschrift für Pflegeberufe, 25, 305-306.

[15]   Luescher, C., Koller, A., Schaefer, I. and Spichiger, E. (2012) Oncological patients’ decision making processes concerning their pain medication at home: A qualitative secondary analysis. Pflege: Die wissenschaftliche Zeitschrift für Pflegeberufe, 25, 353-362.

[16]   National Guideline Clearinghouse (2010) Cancer pain management (general). In: Guidelines on Pain Management, Agency for Healthcare Research and Quality (AHRQ), Rockville.

[17]   Soumerai, S.B. and Avorn, J. (1990) Principles of educational outreach (“academic detailing”) to improve clinical decision making. Journal of the American Medical Association, 263, 549-556.

[18]   Bowen, D.J., Kreuter, M., Spring, B., Cofta-Woerpel, L., Linnan, L., Weiner, D., Bakken, S., Kaplan, C.P., Squiers, L., Fabrizio, C. and Fernandez, M. (2009) How we design feasibility studies. American Journal of Preventive Medicine, 36, 452-457.

[19]   Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T. and Carbone, P.P. (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. American Journal of Clinical Oncology, 5, 649-655.

[20]   Spichiger, E., Muller-Frohlich, C., Denhaerynck, K., Stoll, H., Hantikainen, V. and Dodd, M. (2011) Symptom prevalence and changes of symptoms over ten days in hospitalized patients with advanced cancer: A descriptive study. European Journal of Oncology Nursing, 15, 95-102.

[21]   Lowe, B., Kroenke, K. and Grafe, K. (2005) Detecting and monitoring depression with a two-item questionnaire (PHQ-2). Journal of Psychosomatic Research, 58, 163-171.

[22]   Radbruch, L., Loick, G., Kiencke, P., Lindena, G., Sabatowski, R., Grond, S., Lehmann, K.A. and Cleeland, C.S. (1999) Validation of the German version of the brief pain inventory. Journal of Pain and Symptom Management, 18, 180-187.

[23]   Jensen, M.P. (2003) The validity and reliability of pain measures in adults with cancer. Journal of Pain, 4, 2-21.

[24]   Portenoy, R.K., Thaler, H.T., Kornblith, A.B., Lepore, J.M., Friedlander-Klar, H., Kiyasu, E., Sobel, K., Coyle, N., Kemeny, N., Norton, L., et al. (1994) The memorial symptom assessment scale: An instrument for the evaluation of symptom prevalence, characteristics and distress. European Journal of Cancer, 30A, 1326-1336.

[25]   Vitolins, M.Z., Rand, C.S., Rapp, S.R., Ribisl, P.M. and Sevick, M.A. (2000) Measuring adherence to behavioral and medical interventions, Controlled Clinical Trials, 21, 188S-194S.

[26]   Gandek, B., Ware, J.E., Aaronson, N.K., Apolone, G., Bjorner, J.B., Brazier, J.E., Bullinger, M., Kaasa, S., Leplege, A., Prieto, L. and Sullivan, M. (1998) Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: Results from the IQOLA Project. International Quality of Life Assessment. Journal of Clinical Epidemiology, 51, 1171-1178.

[27]   Lundberg, L., Johannesson, M., Isacson, D.G. and Borgquist, L. (1999) The relationship between health-state utilities and the SF-12 in a general population. Medical Decision Making, 19, 128-140.

[28]   Ware Jr., J., Kosinski, M. and Keller, S.D. (1996) A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 34, 220-233.

[29]   Bullinger, M. (1995) German translation and psychometric testing of the SF-36 health survey: Preliminary results from the IQOLA Project. International Quality of Life Assessment, Social Science and Medicine, 41, 1359-1366.

[30]   Ward, S.E., Goldberg, N., Miller-McCauley, V., Mueller, C., Nolan, A., Pawlik-Plank, D., Robbins, A., Stormoen, D. and Weissman, D.E. (1993) Patient-related barriers to management of cancer pain. Pain, 52, 319-324.

[31]   Gunnarsdottir, S., Donovan, H.S., Serlin, R.C., Voge, C. and Ward, S. (2002) Patient-related barriers to pain management: The Barriers Questionnaire II (BQ-II). Pain, 99, 385-396.

[32]   Mangels, M., Schwarz, S., Sohr, G., Holme, M. and Rief, W. (2009) An adaptation of the pain self-efficacy quesionnaire for the German speaking context. Diagnostica, 55, 84-93.

[33]   Torgerson, D.J. and Sibbald, B. (1998) Understanding controlled trials. What is a patient preference trial? British Medical Journal, 316, 360.

[34]   Cleeland, C.S., Gonin, R., Hatfield, A.K., Edmonson, J.H., Blum, R.H., Stewart, J.A. and Pandya, K.J. (1994) Pain and its treatment in outpatients with metastatic cancer. New England Journal of Medicine, 330, 592-596.

[35]   Beck, S.L. and Falkson, G. (2001) Prevalence and management of cancer pain in South Africa. Pain, 94, 75-84.

[36]   Hyun, M.S., Lee, J.L., Lee, K.H., Shin, S.O., Kwon, K.Y., Song, H.S., Kim, O.B., Sohn, S.K., Lee, K.B., Rhu, H.M., Park, G.W. and Shin, D.G. (2003) Pain and its treatment in patients with cancer in Korea. Oncology, 64, 237-244.

[37]   Sabatowski, R., Arens, E.R., Waap, I. and Radbruch, L. (2001) Cancer pain management in Germany-results and analysis of a questionnaire. Schmerz, 15, 241-247.

[38]   Mayring, P. (2010) Qualitative content analysis: Basic principles and techniques. 11th Edition, Beltz, Weinheim.