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

Non-small Cell Lung Cancer Clinical Trial

— IMPULSO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02336061
• Other study ID #: ICA-QUI-2014-01
• Status: Terminated
• Phase: N/A
• First received: December 3, 2014
• Last updated: December 14, 2017
• Start date: February 3, 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2017
• Source: Asociación para la Investigación del Cáncer de Pulmón en Mujeres
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 344
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Behavioral:
• Evaluation of gender differences on the psychosocial and economic impact.

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital German Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Provincial de Castellón	Castellón de la Plana	Castellón
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico Universitario San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital de Son Llàtzer	Palma de Mallorca	Islas Baleares
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital Arnau de Villanova	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Asociación para la Investigación del Cáncer de Pulmón en Mujeres	Pivotal S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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 ...)	2 years
Secondary	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.	2 years
Secondary	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.	2 years