Cancer, Pain, Chronic
Conditions
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
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)
Interventions
OTHERfollow up system and multimodality approach
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
Sponsors
Mahidol University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Percentage of Satisfied With the Service (Score=3) | Approximately 12 wks from the baseline. | Satisfied score * 1=Dissatisfied * 2=Neutral * 3=Satisfied |
| 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) |
Countries
Thailand
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Cancer Patients |
|---|---|
| Age, Continuous | 58 years |
| BMI (Body Mass Index) | 20.7 kg/m^2 |
| Cancer status Advanced | 121 Participants |
| Cancer status Local | 29 Participants |
| Duration from diagnosis (Days) | 296 days |
| Education Higher than high school | 56 Participants |
| Education High school and below | 94 Participants |
| History of radiation before study | 48 Participants |
| Karnofsky Performance status (KPS) evaluated Functional impairment | 70 Percent |
| Living with Alone | 7 Participants |
| Living with Family/Sibling | 143 Participants |
| Marital status Married | 105 Participants |
| Marital status Single/Divorce/Widow | 45 Participants |
| Morphine Equivalent Diary Dosage | 20 mg/day |
| Numerical Rating Pain scale (0-10: 0 designating no pain, 10 designating worst possible pain) | 5 units on a scale |
| Pain medication taken Acetaminophen | 70 participants |
| Pain medication taken Anticonvulsants | 57 participants |
| Pain medication taken Antidepressants | 21 participants |
| Pain medication taken Antiemetics | 10 participants |
| Pain medication taken Laxatives | 53 participants |
| Pain medication taken NSAIDs | 14 participants |
| Pain medication taken Opioids | 128 participants |
| Primary tumor Breast | 9 Participants |
| Primary tumor Bronchus and lung | 19 Participants |
| Primary tumor Gastrointestinal | 40 Participants |
| Primary tumor Gynecological | 22 Participants |
| Primary tumor Head and neck | 40 Participants |
| Primary tumor Hematological | 4 Participants |
| Primary tumor Musculoskeletal | 4 Participants |
| Primary tumor Urological | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 150 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Thailand | 150 participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 28 / 128 |
| other Total, other adverse events | 32 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
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.
Time frame: Approximately 12 wks from the baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cancer Patients | Improvement of Pain. | 3 score on a scale (0-10) |
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
Time frame: Approximately 12 wks from the baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cancer Patients | Edmonton Symptom Assessment System(ESAS) | 23.5 score on a scale |
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) * 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cancer Patients | Percentage of Moderate to Severe Constipation | 17 Participants |
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) * 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cancer Patients | Percentage of Moderate to Severe Neausea and Vomitting | 9 Participants |
Secondary
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
Time frame: Approximately 12 wks from the baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cancer Patients | Percentage of Moderate to Severe Sedation | 6 Participants |
Secondary
Percentage of Satisfied With the Service (Score=3)
Satisfied score * 1=Dissatisfied * 2=Neutral * 3=Satisfied
Time frame: Approximately 12 wks from the baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cancer Patients | Percentage of Satisfied With the Service (Score=3) | 64 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
Time frame: Approximately 12 wks from the baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cancer Patients | Total Brief Pain Inventory (BPI) | 26 score on a scale |