Pain, ChronicNCT03474406
The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic
An observational study of Pain, Chronic and Cancer, run by Mahidol University at 1 site in Thailand.
Trial summary
-Background: Cancer is one of the most common cause of death. Cancer pain is often cited as one of the most feared in cancer patients. Although, WHO guidelines have been provided to improve pain outcome, the results are still unsatisfied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Cancer
- What is being tested?
- follow up system and multimodality approach
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 3 Jan 2018to 30 Jun 2019
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: The new patients with cancer pain in Siriraj outpatients pain clinic
Who may be able to join
- Cancer pain patients
- more than 18 years old
Who cannot join
- Clinical instability
- Cannot read and write
- Do not know the 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
Official title: The Effectiveness of Cancer Pain Management Including Early Pain Intervention, Early Multi Modality Treatment and Closed Follow up in Siriraj Outpatient Pain Clinic
-Background: Cancer is one of the most common cause of death. Cancer pain is often cited as one of the most feared in cancer patients. Although, WHO guidelines have been provided to improve pain outcome, the results are still unsatisfied. In order to improve cancer pain management we consider to contribute a new guideline which includes interdisciplinary approach, early doing the pain interventions, breakthrough pain, education, high quality of pain assessment and contribute the effectiveness follow-up system
Read the detailed description
- Objectives:Primary outcome is study the effectiveness of new approach and closed follow up system by relief pain intensity 30% at 3 month up to 80% of all new cancer pain patients in OPD setting Secondary outcomes are quality of life (BPI,ESAS), side effect of treatments and the contributing factors that impact on the outcomes
- Study design:A prospective observational study
- Sample size : 150
- Data collection: General information: age, gender, body weight, height, religion, residence, care giver, occupation, income, education, medical problem Clinical pain information: primary diagnosis, staging, cancer site, current medications Clinical assessment: at three study time points: baseline (initial assessment) and the three subsequent follow-ups (FU1, FU2 and FU3)
- Conditions
- Pain, Chronic, Cancer
- Being tested
- follow up system and multimodality approach
- Medical subject headings
- Chronic Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up system and multimodality approachOther
To provide a new service system for cancer pain in pain clinic by early detecting red flag sign to consult other departments, early alleviating severe pain, following patients intensively by telephone call and giving pain education
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Pain.
Numerical Pain Rating Scale Total score 0-10 (0 is best outcome, 10 is worst outcome) 0-3 is mild pain, 4-7 is moderate pain, 7-10 is severe pain.
Measured: Approximately 12 wks from the baseline
Secondary outcomes (6)
Total Brief Pain Inventory (BPI)
To assess the severity of pain and impact on functioning that included worst pain in last 24 hrs, least pain in last 24 hrs, pain average, pain right now, general activity, mood, walking ability, normal work, relationship with other, sleep and enjoyment of life.
Each symptoms scales 0-10 (0 mean no symptom, not interfere, 10 mean most symptom, most interfere) total 70 scores
Measured: Approximately 12 wks from the baseline
Edmonton Symptom Assessment System(ESAS)
To assess multi-directional of patients quality of life, included 9 symptoms ( pain,tired, neausea, depress, anxious, drowsiness, appetite, feeling of well being, shortness of breath) Each symptoms scales 0-9 (0 mean no Symptom, 9 mean most severe symptom) total ESAS 90 scores
Measured: Approximately 12 wks from the baseline
Percentage of Moderate to Severe Sedation
Pasero Opioid-induced Sedation Scale (POSS)
- S=sleep, easy to arouse
- 1=awake/alert
- 2= slight drowsy/easy aroused
- 3=Frequently drowsy, arousable, drifts off to sleep during conversation
- 4=Somnolent, minimal or no response to verbal and physical stimulation Score of 2-4 indicated moderate to severe sedation
Measured: Approximately 12 wks from the baseline.
Percentage of Moderate to Severe Neausea and Vomitting
Four points scale to evaluate opioid induce nausea and vomiting Total scales 0-3 (0 is best outcome, 3 is worst outcome)
- 0= no nausea and vomiting
- 1= mild symptom but not need any treatments. (only neausea)
- 2= moderate symptom, need treatment, can control symptom. (have vomiting can control with medication)
- 3= severe symptom, need treatment, cannot control symptom. (vomiting can not control with medication)
Measured: Approximately 12 wks from the baseline
Percentage of Moderate to Severe Constipation
Stool free interval 72 (sfi72) to evaluate opioid induce costipation (OIC): 0-4.
Total scale 0-4 (0 is best outcome, 4 is worst outcome)
- 0 represented one defecation within the previous 72 hr
- 1 denoted mild constipation (no defecation within the last 72 h)
- 2 referred to the use of a maximum of 3 laxatives
- 3 referred to the use of more than 3 laxatives
- 4 referred to the use of all laxatives have failed Score of 2-4 indicated moderate to severe constipation
Measured: Approximately 12 wks from the baseline
Percentage of Satisfied With the Service (Score=3)
Satisfied score
- 1=Dissatisfied
- 2=Neutral
- 3=Satisfied
Measured: Approximately 12 wks from the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start3 Jan 2018
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ChronicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pain Clinic Siriraj Hospital, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474406
- Sponsor's protocol ID
- Si 622/2017
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2018
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cancer Pain Management Including Early Pain Intervention, Early Multi Modality Treatment and Closed Follow up in Siriraj Outpatient Pain Clinic
- ClinicalTrials.gov ID
- NCT03474406
- Acronym / sponsor ID
- Si 622/2017
- Conditions
- Pain, Chronic, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
-Background: Cancer is one of the most common cause of death. Cancer pain is often cited as one of the most feared in cancer patients. Although, WHO guidelines have been provided to improve pain outcome, the results are still unsatisfied. In order to improve cancer pain management we consider to contribute a new guideline which includes interdisciplinary approach, early doing the pain interventions, breakthrough pain, education, high quality of pain assessment and contribute the effectiveness follow-up system
Detailed description
- Objectives:Primary outcome is study the effectiveness of new approach and closed follow up system by relief pain intensity 30% at 3 month up to 80% of all new cancer pain patients in OPD setting Secondary outcomes are quality of life (BPI,ESAS), side effect of treatments and the contributing factors that impact on the outcomes
- Study design:A prospective observational study
- Sample size : 150
- Data collection: General information: age, gender, body weight, height, religion, residence, care giver, occupation, income, education, medical problem Clinical pain information: primary diagnosis, staging, cancer site, current medications Clinical assessment: at three study time points: baseline (initial assessment) and the three subsequent follow-ups (FU1, FU2 and FU3)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The new patients with cancer pain in Siriraj outpatients pain clinic
Key inclusion criteria (2 listed)
- Cancer pain patients
- more than 18 years old
Key exclusion criteria (3 listed)
- Clinical instability
- Cannot read and write
- Do not know the 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 |
|---|---|---|
| follow up system and multimodality approachTo provide a new service system for cancer pain in pain clinic by early detecting red flag sign to consult other departments, early alleviating severe pain, following patients intensively by telephone call and giving pain education | Other | – |
Primary outcome
Improvement of Pain.
Time frame: Approximately 12 wks from the baseline
Numerical Pain Rating Scale Total score 0-10 (0 is best outcome, 10 is worst outcome) 0-3 is mild pain, 4-7 is moderate pain, 7-10 is severe pain.
6 secondary outcomes
Total Brief Pain Inventory (BPI)
Time frame: Approximately 12 wks from the baseline
Edmonton Symptom Assessment System(ESAS)
Time frame: Approximately 12 wks from the baseline
Percentage of Moderate to Severe Sedation
Time frame: Approximately 12 wks from the baseline.
Percentage of Moderate to Severe Neausea and Vomitting
Time frame: Approximately 12 wks from the baseline
Percentage of Moderate to Severe Constipation
Time frame: Approximately 12 wks from the baseline
Percentage of Satisfied With the Service (Score=3)
Time frame: Approximately 12 wks from the baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Pain Clinic Siriraj Hospital principal investigator
Mahidol University
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 Pain, Chronic and Cancer, 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 2 inclusion and 3 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 16 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement of Pain. (time frame: Approximately 12 wks from the baseline). 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 16 Mar 2021.