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-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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| follow up system and multimodality approach | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 12 wks from the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The new patients with cancer pain in Siriraj outpatients pain clinic
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| Name | Affiliation | Role |
|---|---|---|
| Pain Clinic Siriraj Hospital | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine Siriraj Hospital Mahidol University | Bangkoknoi | Bangkok | 10700 | Thailand |
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We recruited cancer patients who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Cancer Patients | Cancer patients 18 years and older who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients. We excluded patients who had difficulties with listening, reading, and writing Thai and those who were unable to interpret the evaluation form/questionnaires. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cancer Patients | Cancer patients 18 years and older who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients. We excluded patients who had difficulties with listening, reading, and writing Thai and those who were unable to interpret the evaluation form/questionnaires. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale (0-10) | Approximately 12 wks from the baseline |
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|
We collected the adverse effect from pain medication such as sedation score, nausea and vomiting, constipation. from the baseline, FU1, FU2, FU3 (approximately 2-4 weeks eash interval) total 12 weeks.
All cause mortality in this paper was 28 patients in 128 patients. The 28 patients died during the study duet to natural of disease. All patients were at risk because all of patients were diagnosed with cancer and 80% of patients were advanced stage of cancer. The 128 patients were number of patients who decided to treat in our clinic and our hospital during study time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cancer Patients | Cancer patients 18 years and older who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients. We excluded patients who had difficulties with listening, reading, and writing Thai and those who were unable to interpret the evaluation form/questionnaires. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate to severe sedation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asist. Prof. Suratsawadee Wangnamthip | Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University. | 6624197842 | suratsawadee.wan@mahidol.ac.th |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2020 | Dec 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 | Approximately 12 wks from the baseline |
| Percentage of Moderate to Severe Sedation | Pasero Opioid-induced Sedation Scale (POSS)
| 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)
| 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)
| Approximately 12 wks from the baseline |
| Percentage of Satisfied With the Service (Score=3) | Satisfied score
| Approximately 12 wks from the baseline. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (Body Mass Index) | Median | Inter-Quartile Range | kg/m^2 |
|
| Marital status | Count of Participants | Participants |
|
| Living with | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Numerical Rating Pain scale (0-10: 0 designating no pain, 10 designating worst possible pain) | Median | Inter-Quartile Range | units on a scale |
|
| Karnofsky Performance status (KPS) evaluated Functional impairment | (Karnofsky Performance Status (0-100); 100% indicates no functional impairment, no evident disease, 0% indicates death) | Median | Inter-Quartile Range | Percent |
|
| Cancer status | Count of Participants | Participants |
|
| Primary tumor | Count of Participants | Participants |
|
| Pain medication taken | Number | participants |
|
| Morphine Equivalent Diary Dosage | Median | Inter-Quartile Range | mg/day |
|
| History of radiation before study | Count of Participants | Participants |
|
| Duration from diagnosis (Days) | Median | Inter-Quartile Range | days |
|
| Participants |
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Approximately 12 wks from the baseline |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Approximately 12 wks from the baseline |
|
|
|
| Secondary | Percentage of Moderate to Severe Sedation | Pasero Opioid-induced Sedation Scale (POSS)
| Posted | Count of Participants | Participants | Approximately 12 wks from the baseline. |
|
|
|
| Secondary | 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)
| Posted | Count of Participants | Participants | Approximately 12 wks from the baseline |
|
|
|
| Secondary | 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)
| Posted | Count of Participants | Participants | Approximately 12 wks from the baseline |
|
|
|
| Secondary | Percentage of Satisfied With the Service (Score=3) | Satisfied score
| Posted | Count of Participants | Participants | Approximately 12 wks from the baseline. |
|
|
|
| 28 |
| 128 |
| 0 |
| 128 |
| 32 |
| 128 |
| Moderate to severe nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| moderate to severe constipation | Gastrointestinal disorders | Systematic Assessment |
|
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