Clinical trial NCT02336061: Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer
Official title: Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Asociación para la Investigación del Cáncer de Pulmón en Mujeres
Sponsor class: OTHER
Collaborators: name: Pivotal S.L.
First posted: 2015-01-12
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
timeFrame: 2 years
measure: Economic impact (employment status, working hours, income range, public assistance, family support ...)
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 years
measure: Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)
timeFrame: 2 years
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital German Trias i Pujol
state: Barcelona
city: Castellón de la Plana
country: Spain
facility: Hospital Provincial de Castellón
state: Castellón
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Palma de Mallorca
country: Spain
facility: Hospital de Son Llàtzer
state: Islas Baleares
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Villanova
city: Valencia
country: Spain
facility: Hospital La Fe
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Complejo Hospitalario A Coruña
name: María Rosario García, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario Ramón y Cajal
name: Pilar Garrido, MD
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Nuria Viñolas, MD
role: STUDY_CHAIR
References:
citation: 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.