The Edmonton Symptom Assessment System (ESAS) as a Screen... | NCT03686605

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

NCT03686605

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jul 28, 2022Actual

Enrollment

49Actual

Phase

Not provided

Conditions

Screening Tool for Depresion in Cancer Pain Patients

Interventions

Thai version of the Edmontom Symptom Assessment System (ESAS)

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 24, 2018Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Jan 31, 2020Actual

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2022

Last Update Posted Date

Jul 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer pain patients			Other: Thai version of the Edmontom Symptom Assessment System (ESAS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thai version of the Edmontom Symptom Assessment System (ESAS)	Other	Screening and diagnostic questionaire for depression	Cancer pain patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability and validity of Thai version of ESAS	Cut-off point, sensitivity, specificity, positive predictive value and negative predictive value of Thai version of ESAS	1 year

Secondary Outcomes

Measure	Description	Time Frame
Correlation of Thai version of ESAS, HADS and DSM-5	Pearson correlation, Sperman rank correlation	1 year
Internal consistency of Thai version of ESAS and HADS	Cronbach's alpha

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cancer pain patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suratsawadee Wangnamthip, MD	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine Siriraj Hospital Mahidol University		Bangkoknoi	Bangkok	10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided