- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02664987
Analgesic Treatment for Cancer Pain in South East Asia (ACE)
A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Patients receiving cancer pain treatment
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Prescription Pattern of Analgesics (Opioid or Non-opioid)
Tidsram: Day 1
|
At Visit 1 (Day 1) which was the only visit in the study, data was collected on whether each patient was receiving only opioid, only non-opioid or both opioid and non-opioid analgesic treatments for pain control.
|
Day 1
|
Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators
Tidsram: Day 1
|
The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:
Patients and Investigators will each indicate their opinion on separate scales. |
Day 1
|
Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient
Tidsram: Day 1
|
EQ-5D-3L summary indices were calculated using the algorithm developed based on the valuation of EQ-5D-3L health states from an adult Thai population (Tongsiri & Cairns, 2011).
Applying the Thai algorithm, EQ-5D-3L summary indices range from -0.45 to 0.80, with an EQ-5D-3L summary index of 0.80 indicating the best overall health-related quality of life.
|
Day 1
|
Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient
Tidsram: Past 1 day up to Day 1
|
Patients indicated their pain intensity using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Their current pain intensity and pain in the last 24 hours were indicated on separate scales. A higher score indicates higher pain intensity. |
Past 1 day up to Day 1
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient
Tidsram: Past 7 days up to Day 1
|
Patients answered "yes" or "no" to the following question: "Have you had trouble sleeping due to your cancer pain within the last 7 days?" |
Past 7 days up to Day 1
|
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale
Tidsram: Day 1
|
The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 4: 0- Fully active, able to carry on all pre-disease performance without restriction
A higher score indicates greater functional impairment. |
Day 1
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- Thinh DHQ, Sriraj W, Mansor M, Tan KH, Irawan C, Kurnianda J, Nguyen YP, Ong-Cornel A, Hadjiat Y, Moon H, Javier FO. Analgesic Prescription Patterns and Pain Outcomes in Southeast Asia: Findings From the Analgesic Treatment of Cancer Pain in Southeast Asia Study. J Glob Oncol. 2018 Sep;4:1-10. doi: 10.1200/JGO.17.00055.
- Thinh DHQ, Sriraj W, Mansor M, Tan KH, Irawan C, Kurnianda J, Nguyen YP, Ong-Cornel A, Hadjiat Y, Moon H, Javier FO. Patient and Physician Satisfaction with Analgesic Treatment: Findings from the Analgesic Treatment for Cancer Pain in Southeast Asia (ACE) Study. Pain Res Manag. 2018 Apr 18;2018:2193710. doi: 10.1155/2018/2193710. eCollection 2018.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- OPD14-AP-401
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Smärta
-
Korea University Anam HospitalKorea UniversityAvslutadSmärtmätning | Visual Analog Pain Scale
-
Alanya Alaaddin Keykubat UniversityAvslutadSterilisering, Tubal | Visual Analog Pain Scale
-
Turkish Ministry of Health, Kahramanmaras Provincial...RekryteringVisual Analog Pain ScaleKalkon
-
Ankara UniversityAvslutadSmärtmätning | Visual Analog Pain ScaleKalkon
-
East Carolina UniversityIndragen
-
University Hospital, GrenobleAvslutadDövhet | Visual Analog Pain ScaleFrankrike
-
Moens MaartenRekryteringMisslyckad Ryggkirurgi Syndrom | Persistent Spinal Pain Syndrome Typ 2Belgien
-
Moens MaartenVrije Universiteit BrusselRekryteringRyggmärgsstimulering | Persistent Spinal Pain Syndrome Typ 2Belgien
-
Örebro University, SwedenAvslutadPostoperativ smärtintensitet | Rescue Pain KravSverige
-
Wake Forest University Health SciencesRekryteringPhantom Limb Pain (PLP)Förenta staterna
Kliniska prövningar på Patients receiving cancer pain treatment
-
Cameroon Baptist Convention HealthCarolinas Medical CenterAvslutad
-
University of ManitobaOkänd
-
Otsuka Australia Pharmaceutical Pty LtdAvslutadMyelodysplastiskt syndrom (MDS)Australien
-
H. Lee Moffitt Cancer Center and Research InstitutePfizerAktiv, inte rekryterandeNjurcellscancer Steg IVFörenta staterna
-
Groupe Hospitalier de la Region de Mulhouse et...Avslutad
-
Michigan State UniversityNational Institute of Nursing Research (NINR)AvslutadEffekter av starkt ljus på samtidigt förekommande cancerrelaterade symtom hos bröstcanceröverlevandeBröstcancerFörenta staterna
-
University Hospital, Clermont-FerrandAvslutad
-
Washington University School of MedicineAvslutadBröstcancer | Bröstneoplasmer | Bröstcancer | BröstcancerFörenta staterna