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

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Behavioral: Evaluation of gender differences on the psychosocial and economic impact.

• Registration Number: NCT02336061
• Lead Sponsor: Asociación para la Investigación del Cáncer de Pulmón en Mujeres

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-12
• Study Start: 2015-02-03
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 344

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
male	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.

Primary Outcome Measures

Name	Time	Method
Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)	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.
Economic impact (employment status, working hours, income range, public assistance, family support ...)	2 years	The procedures for assessing economic impact are some specific economic variables (employment status, working hours, income range, public assistance, family support ...)

Secondary Outcome Measures

Name	Time	Method
Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)	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.
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).	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.

Trial Locations

Locations (18)

Complexo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Arnau de Villanova; 🇪🇸 Valencia, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital German Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Provincial de Castellón; 🇪🇸 Castellón de la Plana, Castellón, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain

Hospital de Son Llàtzer; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain