Screening Tool for Depresion in Cancer Pain PatientsNCT03686605
The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients
An observational study of Screening Tool for Depresion in Cancer Pain Patients, run by Mahidol University at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Screening Tool for Depresion in Cancer Pain Patients
- What is being tested?
- Thai version of the Edmontom Symptom Assessment System (ESAS)
- How many people
- 49 participants
- Where
- 1 siteThailand
- Study dates
- 24 Sep 2018to 31 Jan 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancer pain patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine Siriraj Hospital Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
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
- Being tested
- Thai version of the Edmontom Symptom Assessment System (ESAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thai version of the Edmontom Symptom Assessment System (ESAS)Other
Also called 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)
Screening and diagnostic questionaire for depression
| Study group | Role | What they receive |
|---|---|---|
| Cancer pain patients | Not described Receives: Other: Thai version of the Edmontom Symptom Assessment System (ESAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Correlation of Thai version of ESAS, HADS and DSM-5
Pearson correlation, Sperman rank correlation
Measured: 1 year
Internal consistency of Thai version of ESAS and HADS
Cronbach's alpha
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start24 Sep 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening Tool for Depresion in Cancer Pain PatientsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suratsawadee Wangnamthip, Mahidol University
- Investigators
- Suratsawadee Wangnamthip, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686605
- Sponsor's protocol ID
- Si 276/2018
- Status last verified
- Jul 2022
- First submitted
- 25 Sep 2018
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients
- ClinicalTrials.gov ID
- NCT03686605
- Acronym / sponsor ID
- Si 276/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer pain patients | – | Other: Thai version of the Edmontom Symptom Assessment System (ESAS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer pain patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thai version of the Edmontom Symptom Assessment System (ESAS)Also: 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)Screening and diagnostic questionaire for depression | Other | Cancer pain patients |
Primary outcome
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
2 secondary outcomes
Correlation of Thai version of ESAS, HADS and DSM-5
Time frame: 1 year
Internal consistency of Thai version of ESAS and HADS
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suratsawadee Wangnamthip, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Screening Tool for Depresion in Cancer Pain Patients, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and validity of Thai version of ESAS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.