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

A

Asociación para la Investigación del Cáncer de Pulmón en Mujeres

Status

Terminated

Conditions

Non-small Cell Lung Cancer

Treatments

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

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02336061
ICA-QUI-2014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

344 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

344 participants in 2 patient groups

male
Description:
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
Treatment:
Behavioral: Evaluation of gender differences on the psychosocial and economic impact.
female
Description:
It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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