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Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer (IMPULSO)

14. december 2017 opdateret af: Asociación para la Investigación del Cáncer de Pulmón en Mujeres

Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.

The purpose of this study is to evaluate of gender differences on the psychosocial and economic impact in patients with advanced non-small cell lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Multi-centre, prospective follow-up post-authorisation study of two patient cohorts with metastatic NSCLC (men and women). It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. The clinical procedures for assessing the tumour and the treatment response will be performed according to the site's standard practice.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

344

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • A Coruña, Spanien, 15006
        • Complexo Hospitalario Universitario A Coruña
      • Barcelona, Spanien, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spanien, 08035
        • Hospital Universitario Vall d'Hebrón
      • Barcelona, Spanien, 08026
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spanien, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
      • Madrid, Spanien, 28040
        • Hospital Clínico Universitario San Carlos
      • Valencia, Spanien, 46026
        • Hospital La Fe
      • Valencia, Spanien, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spanien, 46015
        • Hospital Arnau de Villanova
      • Zaragoza, Spanien, 50009
        • Hospital Clínico Universitario Lozano Blesa
      • Zaragoza, Spanien, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Badalona, Barcelona, Spanien, 08916
        • Hospital German Trias i Pujol
    • Castellón
      • Castellón de la Plana, Castellón, Spanien, 12006
        • Hospital Provincial de Castellon
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spanien, 07010
        • Hospital Universitario Son Espases
      • Palma de Mallorca, Islas Baleares, Spanien, 07198
        • Hospital de Son Llàtzer
    • Madrid
      • Majadahonda, Madrid, Spanien, 28222
        • Hospital Universitario Puerta De Hierro

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Approximately 1250 patients over 18 years of age (approximately 50% men/women), with metastatic NSCLC, who are going to commence first-line treatment and who have a life expectancy of over three months will be included. They will be distributed into two cohorts (men and women) at 50% and will be distributed by age group and smoking status to facilitate the homogeneity between the two cohorts.

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with stage IV NSCLC who are going to commence first line treatment
  • Patients over the age of 18
  • ECOG 0-3
  • Patients who have granted their informed consent, preferably in writing, but otherwise, verbal with witnesses who are independent of the research team
  • Life expectancy of over three months
  • Speak fluent Spanish, in order to be able to complete the study questionnaires
  • Patients able to read and write with no problems

Exclusion Criteria:

  • Previous systemic treatment for metastatic NSCLC. The administration of neoadjuvant or adjuvant radiotherapy and/or chemotherapy is permitted provided it was completed major or equal 6 months prior
  • Dementia or a significantly altered mental state that could affect comprehension or the ability to grant informed consent

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
male
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
Adfærdsmæssigt: Evaluation of gender differences on the psychosocial and economic impact.
female
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
Tidsramme: 2 years
The procedures for assessing psychosocial impact are: Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale. These tests will be performed by the investigator at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
2 years
Economic impact (employment status, working hours, income range, public assistance, family support ...)
Tidsramme: 2 years
The procedures for assessing economic impact are some specific economic variables (employment status, working hours, income range, public assistance, family support ...)
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Influence of treatment (reatment received, treatment received, tumour ssessment, Medical history, including history of smoking, ECOG performance status, associated medical conditions and prior treatments administered (surgery, adjuvant treatment).
Tidsramme: 2 years
The procedures for assessing to influence of treatment are:Treatment received, treatment received, tumour ssessment, Medical history, including history of smoking, ECOG performance status, associated medical conditions and prior treatments administered (surgery, adjuvant treatment). These will be performed in line with the site's standard practice at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
2 years
Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)
Tidsramme: 2 years
The procedures for assessing psychosocial and economic impact are: Zarit Caregiver Burden Questionnaire and Test assessing the economic impact. These will be performed in line with the site's standard practice at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Asociación para la Investigación del Cáncer de Pulmón en Mujeres

Samarbejdspartnere

Pivotal S.L.

Efterforskere

  • Studiestol: María Rosario García, MD, Complejo Hospitalario A Coruña
  • Studiestol: Pilar Garrido, MD, Hospital Universitario Ramón y Cajal
  • Studiestol: Nuria Viñolas, MD, Hospital Clinic of Barcelona

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.

Generelle publikationer

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)

3. februar 2015

Primær færdiggørelse (Faktiske)

30. november 2017

Studieafslutning (Faktiske)

30. november 2017

Datoer for studieregistrering

Først indsendt

3. december 2014

Først indsendt, der opfyldte QC-kriterier

9. januar 2015

Først opslået (Skøn)

12. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ICA-QUI-2014-01

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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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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