CClinicalTrials.gg
Status unknownNCT01914107Updated Aug 27, 2015

Real-time Cancer Pain Assessment and Intervention

A Phase 2/3 interventional study of real-time monitoring and instruction of cancer pain and standard cancer pain care in Malignancy and Pain, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2015-08-27.

Sponsored by Sun Yat-sen University · Phase 2/3, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
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Study summary

This study aim at the advanced malignant tumor patients who suffer from cancer pain, investigate the current status of cancer pain treatment, and study the effects in pain control and quality of life improvement using the method of real-time monitoring and treatment instruction of cancer pain. This study is a randomized, controlled, single center clinical study. After recruitment, the subjects will randomly assign to standard cancer pain treatment group and standard cancer pain treatment plus real-time dynamic monitoring and treatment intervention of cancer pain using the cloud computing concept system. And then, assess the alleviation of cancer pain and quality of live. The assumption is the system will alleviate the cancer pain efficiently.

Read the detailed description
  1. Cancer pain is a common symptom exists in malignant tumor patients, which bother the patients and decrease the quality of life.
  2. The goal of the study is that using the real-time monitoring and intervention system will alleviate cancer pain better than the standard cancer pain treatment.
  3. The cloud computing concept is developed by Sun Yat-sen University cancer center, and accord with clinical practice.
  4. The subjects receive the real-time monitoring and intervention system will install the software and report in the contents of cancer pain in the software correspondingly to the doctors, and advices will be given by the software as well.
  5. The quality of life and overall survival follow-up is also required.
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Conditions studied

  • Malignancy
  • Pain

Keywords

  • malignancy
  • solid tumor
  • cancer pain
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Solid tumors confirmed by pathology or cytology
  • Eastern Cooperative Oncology Group Performance Status: 0-2
  • sign the informed consent form
  • good compliance, willing to comply with the requirements of the study
  • anticipate survival time more than 3 months
  • pain intensity is greater than 2 points according to numerical rating scale on enrollment; have indication of opioid analgesic drugs.
  • can express subjective feelings of pain intensity clearly.
  • own a smartphone or tablet device which can install and use the application program software, and can operate the software proficiently.

Exclusion criteria

Exclusion Criteria:

  • poor compliance, refuse to sign the informed consent form, or difficult to comply with the requirement of the study.
  • slight pain or no pain, no indication of opioid analgesic drugs.
  • contraindication of opioid analgesic drugs
  • no other medical workers give instructions during the study.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    standard cancer pain care

    the standard cancer pain care group: 1.will be follow-up by the cancer nurse once a week to acknowledge the cancer pain intensity, the current analgesic medication, and the side effects. and also give recommendations. 2.filled in the patient'diary and hand over to researchers.

    Procedure: standard cancer pain care

  • Experimental
    real-time monitoring and instruction of cancer pain

    real-time monitoring and treatment instruction of cancer pain group 1.follow the same pattern of standard cancer pain care. 2. using the cloud computing concept system, install the software in the mobile phone of patients. the patients will fill in the content of brief pain inventory, medication and side effect, and upload to researchers every 2 days. 3. Researcher monitor the cancer pain treatment in realtime and give instructions.

    Procedure: real-time monitoring and instruction of cancer pain

Interventions

  • Procedurereal-time monitoring and instruction of cancer pain

    as description in arm

    Also known as: the cloud computing concept based real-time cancer pain assessment and intervetion system

  • Procedurestandard cancer pain care

    as description in arm

    Also known as: standard cancer pain care according to National Comprehensive Cancer Network adult cancer pain guideline

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What researchers measure

Primary outcomes

  1. pain intensity

    the numeric rating scale and visual analogue scale of pain during the chemotherapy. using brief pain inventory scales. in this case, once 2 days in intervention group; once a weeks in control group; and a comprehensive cancer pain assessment according to national comprehensive cancer network adult pain guidance every cycle. within 3 weeks after withdraw, all of the statistics will be analyzed.

    Time frame: up to 9 weeks

  2. duration of pain

    the numeric rating scale and visual analogue scale of pain during the chemotherapy. using brief pain inventory scales. in this case, once 2 days in intervention group; once a weeks in control group; and a comprehensive cancer pain assessment according to national comprehensive cancer network adult pain guidance every cycle. within 3 weeks after withdraw, all of the statistics will be analyzed.

    Time frame: up to 9 weeks

Secondary outcomes

  1. quality of life

    the quality of life assessment will be conducted before the chemotherapy, after 1st cycle chemotherapy, and after 2nd cycle of chemotherapy.

    Time frame: change from baseline of quality of life at 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Publications

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  • Goudas LC, Bloch R, Gialeli-Goudas M, Lau J, Carr DB. The epidemiology of cancer pain. Cancer Invest. 2005;23(2):182-90. PubMed 15813511 ↗
  • Serlin RC, Mendoza TR, Nakamura Y, Edwards KR, Cleeland CS. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain. 1995 May;61(2):277-284. doi: 10.1016/0304-3959(94)00178-H. PubMed 7659438 ↗
  • Deandrea S, Montanari M, Moja L, Apolone G. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol. 2008 Dec;19(12):1985-91. doi: 10.1093/annonc/mdn419. Epub 2008 Jul 15. PubMed 18632721 ↗
  • Costantini M, Ripamonti C, Beccaro M, Montella M, Borgia P, Casella C, Miccinesi G. Prevalence, distress, management, and relief of pain during the last 3 months of cancer patients' life. Results of an Italian mortality follow-back survey. Ann Oncol. 2009 Apr;20(4):729-35. doi: 10.1093/annonc/mdn700. Epub 2009 Jan 22. PubMed 19164455 ↗
  • Apolone G, Corli O, Caraceni A, Negri E, Deandrea S, Montanari M, Greco MT; Cancer Pain Outcome Research Study Group (CPOR SG) Investigators. Pattern and quality of care of cancer pain management. Results from the Cancer Pain Outcome Research Study Group. Br J Cancer. 2009 May 19;100(10):1566-74. doi: 10.1038/sj.bjc.6605053. Epub 2009 Apr 28. PubMed 19401688 ↗
  • Fisch MJ, Lee JW, Weiss M, Wagner LI, Chang VT, Cella D, Manola JB, Minasian LM, McCaskill-Stevens W, Mendoza TR, Cleeland CS. Prospective, observational study of pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer. J Clin Oncol. 2012 Jun 1;30(16):1980-8. doi: 10.1200/JCO.2011.39.2381. Epub 2012 Apr 16. PubMed 22508819 ↗
  • Cleeland CS, Gonin R, Hatfield AK, Edmonson JH, Blum RH, Stewart JA, Pandya KJ. Pain and its treatment in outpatients with metastatic cancer. N Engl J Med. 1994 Mar 3;330(9):592-6. doi: 10.1056/NEJM199403033300902. PubMed 7508092 ↗
  • Von Roenn JH, Cleeland CS, Gonin R, Hatfield AK, Pandya KJ. Physician attitudes and practice in cancer pain management. A survey from the Eastern Cooperative Oncology Group. Ann Intern Med. 1993 Jul 15;119(2):121-6. doi: 10.7326/0003-4819-119-2-199307150-00005. PubMed 8099769 ↗
  • Breuer B, Fleishman SB, Cruciani RA, Portenoy RK. Medical oncologists' attitudes and practice in cancer pain management: a national survey. J Clin Oncol. 2011 Dec 20;29(36):4769-75. doi: 10.1200/JCO.2011.35.0561. Epub 2011 Nov 14. PubMed 22084372 ↗
  • Morita T, Miyashita M, Shibagaki M, Hirai K, Ashiya T, Ishihara T, Matsubara T, Miyoshi I, Nakaho T, Nakashima N, Onishi H, Ozawa T, Suenaga K, Tajima T, Akechi T, Uchitomi Y. Knowledge and beliefs about end-of-life care and the effects of specialized palliative care: a population-based survey in Japan. J Pain Symptom Manage. 2006 Apr;31(4):306-16. doi: 10.1016/j.jpainsymman.2005.09.004. PubMed 16632078 ↗
  • Jacobsen R, Moldrup C, Christrup L, Sjogren P. Patient-related barriers to cancer pain management: a systematic exploratory review. Scand J Caring Sci. 2009 Mar;23(1):190-208. doi: 10.1111/j.1471-6712.2008.00601.x. Epub 2008 Sep 10. PubMed 18785917 ↗
  • Ward SE, Hernandez L. Patient-related barriers to management of cancer pain in Puerto Rico. Pain. 1994 Aug;58(2):233-238. doi: 10.1016/0304-3959(94)90203-8. PubMed 7816490 ↗
  • Weiss SC, Emanuel LL, Fairclough DL, Emanuel EJ. Understanding the experience of pain in terminally ill patients. Lancet. 2001 Apr 28;357(9265):1311-5. doi: 10.1016/S0140-6736(00)04515-3. PubMed 11343734 ↗
  • Yates PM, Edwards HE, Nash RE, Walsh AM, Fentiman BJ, Skerman HM, Najman JM. Barriers to effective cancer pain management: a survey of hospitalized cancer patients in Australia. J Pain Symptom Manage. 2002 May;23(5):393-405. doi: 10.1016/s0885-3924(02)00387-1. PubMed 12007757 ↗
  • Morita T, Tsunoda J, Inoue S, Chihara S. Concerns of Japanese hospice inpatients about morphine therapy as a factor in pain management: a pilot study. J Palliat Care. 2000 Winter;16(4):54-8. No abstract available. PubMed 11965937 ↗
  • Simone CB 2nd, Vapiwala N, Hampshire MK, Metz JM. Palliative care in the management of lung cancer: analgesic utilization and barriers to optimal pain management. J Opioid Manag. 2012 Jan-Feb;8(1):9-16. doi: 10.5055/jom.2012.0091. PubMed 22479880 ↗
  • Zhu J, Davis RB, Stuver SO, Berry DL, Block S, Weeks JC, Weingart SN. A longitudinal study of pain variability and its correlates in ambulatory patients with advanced stage cancer. Cancer. 2012 Dec 15;118(24):6278-86. doi: 10.1002/cncr.27673. Epub 2012 Jun 6. PubMed 22674404 ↗
  • Jensen MP. The validity and reliability of pain measures in adults with cancer. J Pain. 2003 Feb;4(1):2-21. doi: 10.1054/jpai.2003.1. PubMed 14622723 ↗
  • Grossman SA, Sheidler VR, Swedeen K, Mucenski J, Piantadosi S. Correlation of patient and caregiver ratings of cancer pain. J Pain Symptom Manage. 1991 Feb;6(2):53-7. doi: 10.1016/0885-3924(91)90518-9. PubMed 2007792 ↗
  • Clipp EC, George LK. Patients with cancer and their spouse caregivers. Perceptions of the illness experience. Cancer. 1992 Feb 15;69(4):1074-9. doi: 10.1002/1097-0142(19920215)69:43.0.co;2-l. PubMed 1735074 ↗
  • Lamas D, Rosenbaum L. Painful inequities--palliative care in developing countries. N Engl J Med. 2012 Jan 19;366(3):199-201. doi: 10.1056/NEJMp1113622. No abstract available. PubMed 22256803 ↗
  • Smith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, Ferrell BR, Loscalzo M, Meier DE, Paice JA, Peppercorn JM, Somerfield M, Stovall E, Von Roenn JH. American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care. J Clin Oncol. 2012 Mar 10;30(8):880-7. doi: 10.1200/JCO.2011.38.5161. Epub 2012 Feb 6. PubMed 22312101 ↗
  • Charalambous H, Silbermann M. Clinically based palliative care training is needed urgently for all oncologists. J Clin Oncol. 2012 Nov 10;30(32):4042-3; author reply 4043-4. doi: 10.1200/JCO.2012.45.3548. Epub 2012 Sep 17. No abstract available. PubMed 22987079 ↗
  • Peppercorn JM, Smith TJ, Helft PR, Debono DJ, Berry SR, Wollins DS, Hayes DM, Von Roenn JH, Schnipper LE; American Society of Clinical Oncology. American society of clinical oncology statement: toward individualized care for patients with advanced cancer. J Clin Oncol. 2011 Feb 20;29(6):755-60. doi: 10.1200/JCO.2010.33.1744. Epub 2011 Jan 24. PubMed 21263086 ↗
  • de Wit R, van Dam F, Zandbelt L, van Buuren A, van der Heijden K, Leenhouts G, Loonstra S. A pain education program for chronic cancer pain patients: follow-up results from a randomized controlled trial. Pain. 1997 Oct;73(1):55-69. doi: 10.1016/s0304-3959(97)00070-5. PubMed 9414057 ↗
  • Miaskowski C, Dodd M, West C, Schumacher K, Paul SM, Tripathy D, Koo P. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol. 2004 May 1;22(9):1713-20. doi: 10.1200/JCO.2004.06.140. PubMed 15117994 ↗
  • Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. A systematic evaluation of content, structure, and efficacy of interventions to improve patients' self-management of cancer pain. J Pain Symptom Manage. 2012 Aug;44(2):264-84. doi: 10.1016/j.jpainsymman.2011.08.015. PubMed 22871509 ↗
  • Kim EB, Han HS, Chung JH, Park BR, Lim SN, Yim KH, Shin YD, Lee KH, Kim WJ, Kim ST. The effectiveness of a self-reporting bedside pain assessment tool for oncology inpatients. J Palliat Med. 2012 Nov;15(11):1222-33. doi: 10.1089/jpm.2012.0183. Epub 2012 Sep 13. PubMed 22974435 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01914107
Lead sponsor
Sun Yat-sen University
Responsible party
Li Zhang (Professor, Sun Yat-sen University) — Principal investigator
First posted
Aug 1, 2013
Start date
Mar 2012
Primary completion
Dec 2017 (estimated)
Completion
Jun 2018 (estimated)
Last update
Aug 27, 2015

Study contacts

YuXiang Ma, M.D.
Contact
mayx@sysucc.org.cn
86-020-87343786
Li Zhang, professor
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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