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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-03

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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male

It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.

Evaluation of gender differences on the psychosocial and economic impact.

Intervention Type BEHAVIORAL

female

It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.

No interventions assigned to this group

Interventions

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Evaluation of gender differences on the psychosocial and economic impact.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 33228796 (View on PubMed)

Other Identifiers

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ICA-QUI-2014-01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

male

Evaluation of gender differences on the psychosocial and economic impact.

female

Interventions

Evaluation of gender differences on the psychosocial and economic impact.

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pivotal S.L.

Asociación para la Investigación del Cáncer de Pulmón en Mujeres

Responsible Party

Principal Investigators

María Rosario García, MD

Pilar Garrido, MD

Nuria Viñolas, MD

Locations

Hospital Universitario Son Espases

Hospital de Son Llàtzer

Hospital German Trias i Pujol

Hospital Provincial de Castellón

Hospital Universitario Puerta de Hierro

Complexo Hospitalario Universitario A Coruña

Hospital de la Santa Creu i Sant Pau

Hospital Universitario Vall d'Hebron

Hospital Clínic de Barcelona

Hospital Universitario Ramón y Cajal

Fundación Jiménez Díaz

Hospital Clínico Universitario San Carlos

Hospital Universitario La Paz

Hospital General Universitario de Valencia

Hospital Arnau de Villanova

Hospital La Fe

Hospital Clínico Universitario Lozano Blesa

Hospital Universitario Miguel Servet

Countries

References

Other Identifiers

ICA-QUI-2014-01