Purpose: This randomized controlled trial (RCT) protocol was designed to evaluate the effectiveness of the Cancer Pain Monitoring System (CAPAMOS), a telenursing system designed to alleviate pain in ambulatory patients with advanced cancer. Methods: The study design involved a randomized controlled trial consisting of an intervention group using CAPAMOS and a control group that received usual care. At the time of enrollment, both groups will be given a questionnaire regarding issues, such as concerns related to cancer pain and self-management of opioid medication. Patients will then receive pain relief education based on the results of the questionnaire. Subjects in the control group will receive a pain diary and pain-relief pamphlet that acts as an educational tool. They could also call the outpatient clinic if they wanted to ask for a nursing consultation. The intervention group will be able to use CAPAMOS to manage their pain and receive video consultation with a telenurse, who is an oncology nursing specialist. Educational tools will be built into CAPAMOS. The study will be conducted for one month. The primary endpoint of this study was to calculate the Japanese Brief Pain Inventory score. The secondary endpoints were to assess the opioid medication self-management, Barriers Questionnaire, Japanese EuroQol 5-dimensions 5-level, and economic evaluation. Assessment items will be evaluated at registration and 2 and 4 weeks after registration. Conclusions: A RCT based on this protocol is expected to validate the efficacy of telenursing using CAPAMOS in patients with advanced cancer and pain.
References
[1]
Yamagishi, A., Morita, T., Miyashita, M., Mitsunori, M., Ayumi, I., Miki, A., et al. (2012) Pain Intensity, Quality of Life, Quality of Palliative Care, and Satisfaction in Outpatients with Metastatic or Recurrent Cancer: A Japanese, Nationwide, Region-Based, Multicenter Survey. Journal of Pain and Symptom Management, 43, 503-514. https://doi.org/10.1016/j.jpainsymman.2011.04.025
[2]
Ministry of Health, Labour and Welfare (2012) About the Social Security and Tax Reform Charter 2012. https://www.cas.go.jp/jp/seisaku/syakaihosyou/kakugikettei/240217kettei.pdf
[3]
Yoshida, S., Fumiko, S. and Naoko, S. (2019) Relationship between Cancer Pain Self-Management and Pain in Outpatients with Advanced Cancer Taking Opioid Analgesics. Palliative Care Research, 14, 113-126.
[4]
Yoshida, S., Sato, F., Takahashi, C., Inoue, M. and Tomizawa, A. (2021) Self-Management of Opioid Analgesics for Cancer Pain Relief by Patients with Advanced Cancer at Home. Journal of Japanese Society of Cancer Nursing, 35, 254-260.
[5]
Ministry of Internal Affairs and Communications (2013) ICT Super Aging Society Concept Conference Report-Realization of “Smart Platinum Society”. https://www.soumu.go.jp/main_content/000226641.pdf
[6]
Ministry of Health, Labour and Welfare (2014) Health/Medical Strategy. https://www.mhlw.go.jp/file/05-Shingikai-10801000-Iseikyoku-Soumuka/16_9.pdf
[7]
Ministry of Health, Labour and Welfare (2016) Thinking About a Social Model that Overcomes the Aging Population—Annual Report on Health, Labor and Welfare 2016. http://www.mhlw.go.jp/wp/hakusyo/kousei/16/dl/all.pdf
[8]
Galiano-Castillo, N., Cantarero-Villanueva, I., Fernández-Lao, C., Ariza-García, A., Díaz-Rodríguez, L., Del-Moral-ávila, R., et al. (2016) Telehealth System: A Randomized Controlled Trial Evaluating the Impact of an Internet-Based Exercise Intervention on Quality of Life Pain, Muscle Strength, and Fatigue in Breast Cancer Survivors. Cancer, 122, 3166-3174. https://doi.org/10.1002/cncr.30172
[9]
Donovan, H.S., Ward, S.E., Sereika, S.M., Knapp, J.E., Sherwood, P.R., Bender, C.M., et al. (2014) Web-Based Symptom Management for Women with Recurrent Ovarian Cancer: A Pilot Randomized Controlled Trial of the WRITE Symptoms Intervention. Journal of Pain and Symptom Management, 47, 218-230.
[10]
Kroenke, K., Theobald, D., Wu, J., Norton, K., Morrison, G., Carpenter, J., et al. (2010) Effect of Telecare Management on Pain and Depression in Patients with Cancer: A Randomized Trial. JAMA, 304, 163-171. https://doi.org/10.1001/jama.2010.944
[11]
Basch, E., Deal, A.M., Kris, M.G., Scher, H.I., Hudis, C.A., Rogak, P.S., et al. (2016) Symptom Monitoring with Patient-Reported Outcomes during Routine Cancer Treatment. Journal of Clinical Oncology, 34, 557-565. https://doi.org/10.1200/JCO.2015.63.0830
[12]
Basch, E., Deal, A.M., Dueck, A.C., Scher, H.I., Kris, M.G., Hudis, C., et al. (2017) Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring during Routine Cancer Treatment. JAMA, 318, 197-198. https://doi.org/10.1001/jama.2017.7156
[13]
Yoshida, S., Sato, F., Tagami, K., Shimoyama, M. and Takahashi, S. (2021) Evaluating the Pilot Usability for Telenursing-Based Cancer Pain Monitoring System. Palliative Care Research, 16, 99-108.
[14]
Larson-Dahn, M.L. (2000) Tel-eNurse Practice: A Practice Model for Role Expansion. JONA: The Journal of Nursing Administration, 30, 519-523. https://doi.org/10.1097/00005110-200011000-00006
[15]
Larson-Dahn, M.L. (2001) Tel-eNurse Practice. Quality of Care and Patient Outcomes. JONA: The Journal of Nursing Administration, 31, 145-152. https://doi.org/10.1097/00005110-200103000-00011
[16]
Dodd, M., Janson, S., Facione N., Faucett, J., Froelicher, E.S., Humphreys, J., et al. (2001) Advancing the Science of Symptom Management. Journal of Advanced Nursing, 33, 668-676. https://doi.org/10.1046/j.1365-2648.2001.01697.x
[17]
Oldenmenger, W.H., Baan, M.A.G. and van der Rijt, C.C.D. (2018) Development and Feasibility of a Web Application to Monitor Patients’ Cancer-Related Pain. Supportive Care in Cancer, 26, 635-642. https://doi.org/10.1007/s00520-017-3877-3
[18]
Uki, J., Mendoza, T., Cleeland, C.S., Nakamura, Y. and Takeda, F. (1998) A Brief Cancer Pain Assessment Tool in Japanese: The Utility of the Japanese Brief Pain Inventory BPI-J. Journal of Pain and Symptom Management, 16, 364-373.
[19]
Kondo, Y. and Shibuya, S. (2002) Concerns about Morphine and Medication Behavior in Cancer Outpatients with Pain. Journal of Japanese Society of Cancer Nursing, 16, 5-16.
[20]
Ikeda, S., Shiroiwa, T., Igarashi, A., Noto, S., Fukuda, T., Saito, S., et al. (2015) Developing a Japanese Version of the EQ-5D-5L Value Set. Journal of the National Institute of Public Health, 64, 47-55.
[21]
Ruland, C.M., Andersen, T., Jeneson, A., Moore, S., Grimsbø, G.H., Børøsund, E., et al. (2013) Effects of an Internet Support System to Assist Cancer Patients in Reducing Symptom Distress: A Randomized Controlled Trial. Cancer Nursing, 36, 6-17. https://doi.org/10.1097/NCC.0b013e31824d90d4
[22]
Swarm, R.A., Paice, J.A., Anghelescu, D.L., Are, M., Bruce, J.Y., Buga, S., et al. (2019) Adult Cancer Pain, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. Journal of the National Comprehensive Cancer Network, 17, 977-1007.
[23]
Japanese Society for Palliative Medicine, Palliative Medicine Guidelines Preparation Committee (2014) Guidelines Related to Pharmacotherapy for Cancer Pain. Kanehara Publishing, Tokyo, 212-219.
[24]
Tagami, K., Okizaki, A., Miura, T., Watanabe, Y.S., Matsumoto, Y., Morita, T., et al. (2018) Breakthrough Cancer Pain Influences General Activities and Pain Management: A Comparison of Patients with and without Breakthrough Cancer Pain. Journal of Palliative Medicine, 21, 1636-1640. https://doi.org/10.1089/jpm.2017.0675
[25]
Davies, A., Buchanan, A., Zeppetella, G., Josep, P.S., Rudolf, L., Wolfgang, W., et al. (2013) Breakthrough Cancer Pain: An Observational Study of 1000 European Oncology Patients. Journal of Pain and Symptom Management, 46, 619-628. https://doi.org/10.1016/j.jpainsymman.2012.12.009
[26]
Moher, D., Hopewell, S., Schulz, K.F., Montori, V., Gøtzsche, P.C., Devereaux, P.J., et al. (2012) CONSORT 2010 Explanation and Elaboration: Updated Guidelines for Reporting Parallel Group Randomized Trials. International Journal of Surgery Open, 10, 28-55. https://doi.org/10.1016/j.ijsu.2011.10.001
[27]
Japanese Nursing Association (2021) About Certified Nurse Specialist. https://nintei.nurse.or.jp/nursing/qualification/probation_guide_cns
[28]
Ministry of Health, Labour and Welfare (2016) About Utilization of ICT in Medical Care. https://www.niph.go.jp/h-crisis/wp-content/uploads/2019/06/000517305.pdf
