Trial Outcomes & Findings for The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic (NCT NCT03474406)

NCT ID: NCT03474406

Last Updated: 2021-03-16

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 150 participants
• Primary outcome timeframe: Approximately 12 wks from the baseline
• Results posted on: 2021-03-16

Participant Flow

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

Participant milestones

Measure	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.
Overall Study STARTED	150
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	78

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic

Baseline characteristics by cohort

Measure	Cancer Patients n=150 Participants 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.
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	150 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Thailand	150 participants n=5 Participants
BMI (Body Mass Index)	20.7 kg/m^2 n=5 Participants
Marital status Married	105 Participants n=5 Participants
Marital status Single/Divorce/Widow	45 Participants n=5 Participants
Living with Family/Sibling	143 Participants n=5 Participants
Living with Alone	7 Participants n=5 Participants
Education High school and below	94 Participants n=5 Participants
Education Higher than high school	56 Participants n=5 Participants
Numerical Rating Pain scale (0-10: 0 designating no pain, 10 designating worst possible pain)	5 units on a scale n=5 Participants
Karnofsky Performance status (KPS) evaluated Functional impairment	70 Percent n=5 Participants
Cancer status Local	29 Participants n=5 Participants
Cancer status Advanced	121 Participants n=5 Participants
Primary tumor Gastrointestinal	40 Participants n=5 Participants
Primary tumor Bronchus and lung	19 Participants n=5 Participants
Primary tumor Breast	9 Participants n=5 Participants
Primary tumor Head and neck	40 Participants n=5 Participants
Primary tumor Hematological	4 Participants n=5 Participants
Primary tumor Gynecological	22 Participants n=5 Participants
Primary tumor Urological	12 Participants n=5 Participants
Primary tumor Musculoskeletal	4 Participants n=5 Participants
Pain medication taken Opioids	128 participants n=5 Participants
Pain medication taken Acetaminophen	70 participants n=5 Participants
Pain medication taken NSAIDs	14 participants n=5 Participants
Pain medication taken Anticonvulsants	57 participants n=5 Participants
Pain medication taken Antidepressants	21 participants n=5 Participants
Pain medication taken Laxatives	53 participants n=5 Participants
Pain medication taken Antiemetics	10 participants n=5 Participants
Morphine Equivalent Diary Dosage	20 mg/day n=5 Participants
History of radiation before study	48 Participants n=5 Participants
Duration from diagnosis (Days)	296 days n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cancer Patients n=72 Participants 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.
Improvement of Pain.	3 score on a scale (0-10) Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cancer Patients n=72 Participants 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.
Total Brief Pain Inventory (BPI)	26 score on a scale Interval 8.5 to 40.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cancer Patients n=72 Participants 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.
Edmonton Symptom Assessment System(ESAS)	23.5 score on a scale Interval 10.5 to 36.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cancer Patients n=72 Participants 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.
Percentage of Moderate to Severe Sedation	6 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Cancer Patients n=72 Participants 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.
Percentage of Moderate to Severe Neausea and Vomitting	9 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cancer Patients n=72 Participants 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.
Percentage of Moderate to Severe Constipation	17 Participants

SECONDARY outcome

Timeframe: Approximately 12 wks from the baseline.

Satisfied score

• 1=Dissatisfied
• 2=Neutral
• 3=Satisfied

Outcome measures

Measure	Cancer Patients n=72 Participants 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.
Percentage of Satisfied With the Service (Score=3)	64 Participants

Adverse Events

Cancer Patients

Serious events: 0 serious events

Other events: 32 other events

Deaths: 28 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cancer Patients n=128 participants at risk 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.
Nervous system disorders Moderate to severe sedation	4.7% 6/128 • 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.
Gastrointestinal disorders Moderate to severe nausea and vomiting	7.0% 9/128 • 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.
Gastrointestinal disorders moderate to severe constipation	13.3% 17/128 • 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.

Additional Information

Asist. Prof. Suratsawadee Wangnamthip

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University.

Phone: 6624197842

Email: suratsawadee.wan@mahidol.ac.th

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place