An observational study in Non-small Cell Lung Cancer, sponsored by Asociación para la Investigación del Cáncer de Pulmón en Mujeres. Terminated at 18 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-15.
Sponsored by Asociación para la Investigación del Cáncer de Pulmón en Mujeres · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 344 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →This is the only study on the registry with Asociación para la Investigación del Cáncer de Pulmón en Mujeres as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
Behavioral: Evaluation of gender differences on the psychosocial and economic impact.
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
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.
Time frame: 2 years
Economic impact (employment status, working hours, income range, public assistance, family support ...)
The procedures for assessing economic impact are some specific economic variables (employment status, working hours, income range, public assistance, family support ...)
Time frame: 2 years
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).
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.
Time frame: 2 years
Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)
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.
Time frame: 2 years
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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