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

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ClinicalTrials.gov Identifier: NCT02336061
Recruitment Status : Terminated (Sponsor decision due to the low recruitment rate)
First Posted : January 12, 2015
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Pivotal S.L.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer 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
Actual Enrollment : 344 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.
Actual Study Start Date : February 3, 2015
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.



Primary Outcome Measures :
  1. Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale) [ Time Frame: 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.

  2. Economic impact (employment status, working hours, income range, public assistance, family support ...) [ Time Frame: 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 :
  1. 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). [ Time Frame: 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.

  2. Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336061


Locations
Spain
Hospital German Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Provincial de Castellón
Castellón de la Plana, Castellón, Spain, 12006
Hospital Universitario Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
Hospital de Son Llàtzer
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08026
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Clínico Universitario San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Arnau de Villanova
Valencia, Spain, 46015
Hospital La Fe
Valencia, Spain, 46026
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Asociación para la Investigación del Cáncer de Pulmón en Mujeres
Pivotal S.L.
Investigators
Study Chair: María Rosario García, MD Complejo Hospitalario A Coruña
Study Chair: Pilar Garrido, MD Hospital Universitario Ramón y Cajal
Study Chair: Nuria Viñolas, MD Hospital Clinic of Barcelona

Responsible Party: Asociación para la Investigación del Cáncer de Pulmón en Mujeres
ClinicalTrials.gov Identifier: NCT02336061     History of Changes
Other Study ID Numbers: ICA-QUI-2014-01
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms