Non-small Cell Lung Cancer
Conditions
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.
Interventions
BEHAVIORALEvaluation of gender differences on the psychosocial and economic impact.
Sponsors
Pivotal S.L.
Asociación para la Investigación del Cáncer de Pulmón en Mujeres
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale) | 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. |
| Economic impact (employment status, working hours, income range, public assistance, family support ...) | 2 years | The procedures for assessing economic impact are some specific economic variables (employment status, working hours, income range, public assistance, family support ...) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact) | 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. |
Countries
Spain
Outcome results
None listed