NCT03205579

Brief Summary

Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not affect only physical but also emotional and quality of life. From review literatures we found that patients' knowledge about cancer pain management is inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer treatments, which can cause of unfavorable pain management outcome. Therefore, we will conduct the RCT of using pain education by video comparing to conventional face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs examination for testing pre-post intervention to test level of understanding of patients. The measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that NRS should improve more than 50% at the seven day of study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

June 29, 2017

Last Update Submit

August 3, 2022

Conditions

PainInpatientCancer

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    The pain reduction will be assessed and compared using numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between the first day and the seventh day of study

    seven days

Secondary Outcomes (2)

  • Emotional status

    seven days

  • Functional assessment

    seven days

Study Arms (2)

Video group

EXPERIMENTAL

Video cancer pain education (10 minutes ) the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.

Other: Video group

Conventional group

ACTIVE COMPARATOR

Face to face cancer pain education by trained nurse (10 minutes)the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.

Other: conventional group

Interventions

Video groupOTHER

Using video for educate cancer pain patients

Video group
conventional groupOTHER

Face to face cancer pain education by trained nurse

Conventional group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate to severe pain (NRS\>4) cancer pain
  • ECOG (Eastern cooperative Oncology group) performance status \<=3
  • Can read, listen, write Thai language

You may not qualify if:

  • Clinical instability
  • Confusion and delirium
  • Bed ridden
  • Psychotic problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (4)

  • Wangnamthip S, Euasobhon P, Siriussawakul A, Jirachaipitak S, Laurujisawat J, Vimolwattanasarn K. Effective Pain Management for Inpatients at Siriraj Hospital: A Retrospective Study. J Med Assoc Thai. 2016 May;99(5):565-71.

    PMID: 27501612RESULT

  • van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.

    PMID: 17355955RESULT

  • Yates P, Dewar A, Edwards H, Fentiman B, Najman J, Nash R, Richardson V, Fraser J. The prevalence and perception of pain amongst hospital in-patients. J Clin Nurs. 1998 Nov;7(6):521-30. doi: 10.1046/j.1365-2702.1998.00192.x.

    PMID: 10222947RESULT

  • Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998 Jul 8;280(2):147-51. doi: 10.1001/jama.280.2.147.

    PMID: 9669787RESULT

MeSH Terms

Conditions

PainNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suratsawadee Wangnamthip, md

    Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

September 20, 2018

Primary Completion

September 30, 2019

Study Completion

July 18, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

TH(2)