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Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw

5. januar 2018 opdateret af: Amgen

Survey of Oncology Practitioners Prescribing XGEVA® in Europe to Evaluate Their Knowledge of XGEVA® Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw

Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer. Detailed information regarding this risk is specified in the Summary of Product Characteristics (SPC). The statements in the SPC are the most important mechanism for minimizing the risk for ONJ. The study objective is to measure the knowledge of oncology practitioners prescribing XGEVA® regarding the content pertaining to ONJ in the SPC after commercial availability.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

This is a multiple cross-sectional survey study of practicing oncology practitioners prescribing XGEVA in Europe from across but not limited to the 5 largest European countries by population (including France, Germany, Italy, Spain and the U.K.) and 4 Nordic countries (Denmark, Finland, Norway and Sweden). The survey will be conducted in two rounds. The two survey rounds will be conducted 12 to 18 months and 24 to 30 months after XGEVA becomes commercially available in the participating countries. The initial contact and screening of potential participating oncology practitioners will continue until a total of 210 eligible and consenting oncology practitioners complete the survey per round. For the 5 largest European countries by population, it is intended that 30 oncology practitioners will be surveyed per country per survey round. If this sample size cannot be achieved, oncology practitioners from another country in that region will be surveyed to achieve a regional sample size of 150 per survey round. Oncology practitioners from the Nordic countries will be surveyed to achieve a regional sample size of 60 per survey round. For all countires, the number of surveys collected in each country in the second survey round will, where possible, equate to the number of surveys collected in each country in the first survey round.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

420

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Oncology specialists treating adult patients with bone metastases from solid tumours

Beskrivelse

Practicing oncology specialists who have treated at least 5 adult patients with bone metastases from solid tumours in the last quarter. Must have prescribed XGEVA® within the last 12 months. Must not have participated in a previous survey round

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Round 1
Survey of 210 oncologists 12 - 18 months after commercial availability of XGEVA® in the respective country
Eligible physicians will be contacted to perform the physician survey. A standardised online questionnaire will be used to collect information about the physician's awareness of the Summary of Product characteristics (SPC) pertaining to osteonecrosis of the jaw (ONJ) in the last 6-18 months.
Andre navne:
  • This is an observational study.
Round 2
Survey of 210 oncologists 24 - 30 months after commercial availability of XGEVA® in the respective country
Eligible physicians will be contacted to perform the physician survey. A standardised online questionnaire will be used to collect information about the physician's awareness of the Summary of Product characteristics (SPC) pertaining to osteonecrosis of the jaw (ONJ) in the last 6-18 months.
Andre navne:
  • This is an observational study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round)
Tidsramme: 12 and 24 months after commercial availability of XGEVA® in the respective country
12 and 24 months after commercial availability of XGEVA® in the respective country

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. februar 2013

Primær færdiggørelse (Faktiske)

15. maj 2015

Studieafslutning (Faktiske)

15. maj 2015

Datoer for studieregistrering

Først indsendt

25. november 2013

Først indsendt, der opfyldte QC-kriterier

25. november 2013

Først opslået (Skøn)

2. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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