N/A
N=462
Analgesic Treatment for Cancer Pain in South East Asia
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02664987 ↗Enrolled (actual)
462
Serious AEs
—
Results posted
Oct 2016
Primary outcome: Primary: Prescription Pattern of Analgesics (Opioid or Non-opioid) — 37.27; 11.33; 51.40 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Patients receiving cancer pain treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mundipharma Pte Ltd.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prescription Pattern of Analgesics (Opioid or Non-opioid) |
37.27; 11.33; 51.40 | — |
| PRIMARY Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators |
18.6; 41.6; 30.3; 8.0; 1.5; 12.1 | — |
| PRIMARY Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient |
0.45 | — |
| PRIMARY Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient |
4.10; 4.76 | — |
| SECONDARY Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient |
45.2; 54.8 | — |
| SECONDARY Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale |
14.9; 42.7; 26.6; 13.6; 2.2 | — |
Summary
This study is planned to investigate the pain control status in cancer patients in 6 South East Asian countries through evaluation of prescription pattern of analgesics, satisfaction of pain control, quality of life and assessment of the adequacy of pain control and relationship among these factors in cancer patients with pain. Cancer pain is undermanaged and it is hoped that this study will be used as a reference for effective cancer pain management in these countries.
Eligibility Criteria
Inclusion Criteria
- Adult (over 18 years) cancer patients [country variation would be accepted based on the definition of adults]
- Cancer has been diagnosed pathologically
- Out-patients with cancer pain due to cancer itself or its treatment
- Patients being treated with any analgesics for more than one month for the management of cancer pain at enrolment
- Patients who are willing to voluntarily sign the study consent form
Exclusion Criteria
- Patients who have had an operation for any reasons within 3 months prior to the enrolment
- Patients with any oncologic emergency
- Patients who had any interventional therapy (e.g. nerve block, neurolytic procedures) related to their cancer pain within 6 weeks of study entry
- Insufficient ability or willingness to cooperate
- Patients who are judged not suitable to participate in this study by the investigator
- Patients who are participating in any other interventional clinical trials for cancer treatment or supportive care
Data sourced from ClinicalTrials.gov (NCT02664987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.