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Analgesic Treatment for Cancer Pain in South East Asia (ACE)

8. september 2016 oppdatert av: Mundipharma Pte Ltd.

A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

462

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Subjects were selected from government and private hospitals that see cancer patients.

Beskrivelse

Inclusion Criteria:

  1. Adult (over 18 years) cancer patients [country variation would be accepted based on the definition of adults]
  2. Cancer has been diagnosed pathologically
  3. Out-patients with cancer pain due to cancer itself or its treatment
  4. Patients being treated with any analgesics for more than one month for the management of cancer pain at enrolment
  5. Patients who are willing to voluntarily sign the study consent form

Exclusion Criteria:

  1. Patients who have had an operation for any reasons within 3 months prior to the enrolment
  2. Patients with any oncologic emergency
  3. Patients who had any interventional therapy (e.g. nerve block, neurolytic procedures) related to their cancer pain within 6 weeks of study entry
  4. Insufficient ability or willingness to cooperate
  5. Patients who are judged not suitable to participate in this study by the investigator
  6. Patients who are participating in any other interventional clinical trials for cancer treatment or supportive care

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Patients receiving cancer pain treatment
Annen: Patients receiving cancer pain treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prescription Pattern of Analgesics (Opioid or Non-opioid)
Tidsramme: 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
Tidsramme: Day 1

The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:

  1. Very satisfied
  2. Satisfied
  3. Acceptable
  4. Dissatisfied
  5. Very dissatisfied

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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient
Tidsramme: 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
Tidsramme: 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

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
  4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

A higher score indicates greater functional impairment.
Day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mundipharma Pte Ltd.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2015

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

22. januar 2016

Først innsendt som oppfylte QC-kriteriene

22. januar 2016

Først lagt ut (Anslag)

27. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • OPD14-AP-401

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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