Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer (IMPULSO)
14. desember 2017 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
344
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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A Coruña, Spania, 15006
- Complexo Hospitalario Universitario A Coruña
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Barcelona, Spania, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spania, 08035
- Hospital Universitario Vall d'Hebron
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Barcelona, Spania, 08026
- Hospital de La Santa Creu i Sant Pau
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Madrid, Spania, 28040
- Fundación Jiménez Díaz
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Madrid, Spania, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spania, 28046
- Hospital Universitario La Paz
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Madrid, Spania, 28040
- Hospital Clinico Universitario San Carlos
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Valencia, Spania, 46026
- Hospital La Fe
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Valencia, Spania, 46014
- Hospital General Universitario de Valencia
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Valencia, Spania, 46015
- Hospital Arnau de Villanova
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Zaragoza, Spania, 50009
- Hospital Clínico Universitario Lozano Blesa
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Zaragoza, Spania, 50009
- Hospital Universitario Miguel Servet
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Hospital German Trias i Pujol
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Castellón
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Castellón de la Plana, Castellón, Spania, 12006
- Hospital Provincial de Castellon
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spania, 07010
- Hospital Universitario Son Espases
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Palma de Mallorca, Islas Baleares, Spania, 07198
- Hospital de Son Llàtzer
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Madrid
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Majadahonda, Madrid, Spania, 28222
- Hospital Universitario Puerta De Hierro
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-
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
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
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 |
|---|---|
|
male
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
|
|
|
female
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: María Rosario García, MD, Complejo Hospitalario A Coruña
- Studiestol: Pilar Garrido, MD, Hospital Universitario Ramon y Cajal
- Studiestol: Nuria Viñolas, MD, Hospital Clinic of Barcelona
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.
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 (Faktiske)
3. februar 2015
Primær fullføring (Faktiske)
30. november 2017
Studiet fullført (Faktiske)
30. november 2017
Datoer for studieregistrering
Først innsendt
3. desember 2014
Først innsendt som oppfylte QC-kriteriene
9. januar 2015
Først lagt ut (Anslag)
12. januar 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. desember 2017
Sist bekreftet
1. desember 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ICA-QUI-2014-01
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