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

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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Behavioral: Evaluation of gender differences on the psychosocial and economic impact.

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 Type: Observational
• Enrollment (Actual): 344

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
male; 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.
female; It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Asociación para la Investigación del Cáncer de Pulmón en Mujeres
• Collaborators: Pivotal S.L.
• Investigators: Study Chair: María Rosario García, MD, Complejo Hospitalario A Coruña; Study Chair: Pilar Garrido, MD, Hospital Universitario Ramon y Cajal; Study Chair: Nuria Viñolas, MD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Vinolas NN, Garcia-Campelo R, Majem M, Carcereny E, Isla D, Gonzalez-Larriba JL, Coves J, De-Castro J, Domine M, Lianes P, Artal A, Remon J, Felip E, Garrido P. Assessment of the psychosocial and economic impact according to sex in non-small cell lung cancer patients: an exploratory longitudinal study. BMC Psychol. 2020 Nov 23;8(1):123. doi: 10.1186/s40359-020-00489-z.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2015
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ICA-QUI-2014-01