The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03474406
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Actual Duration (Months): 17.8
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief 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. 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

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic; Cancer	Other: follow up system and multimodality approach

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 3, 2018
• Actual Primary Completion Date: Mar 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Outcome Measures

Primary Outcome Measures

1. Improvement of Pain. [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.

Secondary Outcome Measures

1. Total Brief Pain Inventory (BPI) [Approximately 12 wks from the baseline]

   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

2. Edmonton Symptom Assessment System(ESAS) [Approximately 12 wks from the baseline]

   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

3. Percentage of Moderate to Severe Sedation [Approximately 12 wks from the baseline.]

   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

4. Percentage of Moderate to Severe Neausea and Vomitting [Approximately 12 wks from the baseline]

   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)

5. Percentage of Moderate to Severe Constipation [Approximately 12 wks from the baseline]

   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

6. Percentage of Satisfied With the Service (Score=3) [Approximately 12 wks from the baseline.]

   Satisfied score 1=Dissatisfied 2=Neutral 3=Satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cancer pain patients

• more than 18 years old

Exclusion Criteria:

• Clinical instability

• Cannot read and write

• Do not know the diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine Siriraj Hospital Mahidol University	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Pain Clinic Siriraj Hospital, Mahidol University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 18, 2020

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03474406
• Other Study ID Numbers: Si 622/2017
• First Posted: Mar 22, 2018
• Last Update Posted: Mar 16, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cancer Pain; Chronic Pain

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Period Title: Overall Study
STARTED	150
COMPLETED	72
NOT COMPLETED	78

Baseline Characteristics

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Overall Participants	150
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	58
Sex: Female, Male (Count of Participants)
Female	65 43.3%
Male	85 56.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	150 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Thailand	150 100%
BMI (Body Mass Index) (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	20.7
Marital status (Count of Participants)
Married	105 70%
Single/Divorce/Widow	45 30%
Living with (Count of Participants)
Family/Sibling	143 95.3%
Alone	7 4.7%
Education (Count of Participants)
High school and below	94 62.7%
Higher than high school	56 37.3%
Numerical Rating Pain scale (0-10: 0 designating no pain, 10 designating worst possible pain) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	5
Karnofsky Performance status (KPS) evaluated Functional impairment (Percent) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Percent]	70
Cancer status (Count of Participants)
Local	29 19.3%
Advanced	121 80.7%
Primary tumor (Count of Participants)
Gastrointestinal	40 26.7%
Bronchus and lung	19 12.7%
Breast	9 6%
Head and neck	40 26.7%
Hematological	4 2.7%
Gynecological	22 14.7%
Urological	12 8%
Musculoskeletal	4 2.7%
Pain medication taken (participants) [Number]
Opioids	128 85.3%
Acetaminophen	70 46.7%
NSAIDs	14 9.3%
Anticonvulsants	57 38%
Antidepressants	21 14%
Laxatives	53 35.3%
Antiemetics	10 6.7%
Morphine Equivalent Diary Dosage (mg/day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/day]	20
History of radiation before study (Count of Participants)
Count of Participants [Participants]	48 32%
Duration from diagnosis (Days) (days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [days]	296

Outcome Measures

1. Primary Outcome

Title	Improvement of Pain.
Description	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.
Time Frame	Approximately 12 wks from the baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Measure Participants	72
Median (Inter-Quartile Range) [score on a scale (0-10)]	3

2. Secondary Outcome

Title	Total Brief Pain Inventory (BPI)
Description	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
Time Frame	Approximately 12 wks from the baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Measure Participants	72
Median (Inter-Quartile Range) [score on a scale]	26

3. Secondary Outcome

Title	Edmonton Symptom Assessment System(ESAS)
Description	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
Time Frame	Approximately 12 wks from the baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Measure Participants	72
Median (Inter-Quartile Range) [score on a scale]	23.5

4. Secondary Outcome

Title	Percentage of Moderate to Severe Sedation
Description	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
Time Frame	Approximately 12 wks from the baseline.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Measure Participants	72
Count of Participants [Participants]	6 4%

5. Secondary Outcome

Title	Percentage of Moderate to Severe Neausea and Vomitting
Description	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)
Time Frame	Approximately 12 wks from the baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Measure Participants	72
Count of Participants [Participants]	9 6%

6. Secondary Outcome

Title	Percentage of Moderate to Severe Constipation
Description	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
Time Frame	Approximately 12 wks from the baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Measure Participants	72
Count of Participants [Participants]	17 11.3%

7. Secondary Outcome

Title	Percentage of Satisfied With the Service (Score=3)
Description	Satisfied score 1=Dissatisfied 2=Neutral 3=Satisfied
Time Frame	Approximately 12 wks from the baseline.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer Patients
Arm/Group Description	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.
Measure Participants	72
Count of Participants [Participants]	64 42.7%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Cancer Patients
Arm/Group Description	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.
All Cause Mortality
	Cancer Patients
	Affected / at Risk (%)	# Events
Total	28/128 (21.9%)
Serious Adverse Events
	Cancer Patients
	Affected / at Risk (%)	# Events
Total	0/128 (0%)
Other (Not Including Serious) Adverse Events
	Cancer Patients
	Affected / at Risk (%)	# Events
Total	32/128 (25%)
Gastrointestinal disorders
Moderate to severe nausea and vomiting	9/128 (7%)
moderate to severe constipation	17/128 (13.3%)
Nervous system disorders
Moderate to severe sedation	6/128 (4.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.