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

NCT02336061 | Terminated DMC

• 1 other identifier: ICA-QUI-2014-01
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 18

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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).

  2 years

• Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)

  2 years

Study Arms (2)

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.

Interventions

Evaluation of gender differences on the psychosocial and economic impact. BEHAVIORAL

male

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asociación para la Investigación del Cáncer de Pulmón en Mujeres: lead
• Pivotal S.L.: collaborator

Study Sites (18)

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital de Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital German Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Provincial de Castellón

Castellon, Castellón, 12006, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Arnau de Villanova

Valencia, 46015, Spain

Location

Hospital La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 33228796 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: January 12, 2015
• Study Start: February 3, 2015
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

ES (18)