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The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients

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ClinicalTrials.gov Identifier: NCT03686605
Recruitment Status : Unknown
Verified July 2018 by Suratsawadee Wangnamthip, Mahidol University.
Recruitment status was:  Enrolling by invitation
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Suratsawadee Wangnamthip, Mahidol University

Tracking Information
First Submitted Date September 25, 2018
First Posted Date September 27, 2018
Last Update Posted Date September 27, 2018
Actual Study Start Date September 24, 2018
Estimated Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2018)
Reliability and validity of Thai version of ESAS [ Time Frame: 1 year ]
Cut-off point, sensitivity, specificity, positive predictive value and negative predictive value of Thai version of ESAS
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 25, 2018)
  • Correlation of Thai version of ESAS, HADS and DSM-5 [ Time Frame: 1 year ]
    Pearson correlation, Sperman rank correlation
  • Internal consistency of Thai version of ESAS and HADS [ Time Frame: 1 year ]
    Cronbach's alpha
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients
Official Title The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients
Brief Summary Compare Thai versions of the Edmonton Symptom Assessment System (ESAS) and the Hospiral Anxiety and Depression Scale (HADS) with Diagnostic and Statistical Manual (DSM-5), as a screening tool for depression in cancer pain patients
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cancer pain patients
Condition Screening Tool for Depresion in Cancer Pain Patients
Intervention Other: Thai version of the Edmontom Symptom Assessment System (ESAS)
Screening and diagnostic questionaire for depression
Other Names:
  • Thai version of the Hospital Anxiety and Depression Scale (HADS)
  • Thai version of 2Q
  • Thai version of the Mini International Neuropsychiatric Interview (M.I.N.I.)
  • Thai version of the Diagnostic and Statistical Manual (DSM-5)
Study Groups/Cohorts Cancer pain patients
Intervention: Other: Thai version of the Edmontom Symptom Assessment System (ESAS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 25, 2018)
44
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2019
Estimated Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Cancer patients who follow up as out patient at pain clinic, Siriraj hospital
  • Age older than 18 years old
  • Fluently read, write and speak in Thai language
  • No cognitive impairment

Exclusion Criteria:

  • Unstable clinical presentation
  • Severe pain or pain numerical rating scale more than 7
  • Severe associated symptoms such as nausea, vomiting
  • The patient who do not know their diagnosis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT03686605
Other Study ID Numbers Si 276/2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Suratsawadee Wangnamthip, Mahidol University
Study Sponsor Mahidol University
Collaborators Not Provided
Investigators
Principal Investigator: Suratsawadee Wangnamthip, MD Lecturer
PRS Account Mahidol University
Verification Date July 2018