Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Asociación para la Investigación del Cáncer de Pulmón en Mujeres
- Enrollment
- 344
- Locations
- 18
- Primary Endpoint
- Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with stage IV NSCLC who are going to commence first line treatment
- •Patients over the age of 18
- •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
Outcomes
Primary Outcomes
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.
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 Outcomes
- Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)(2 years)
- 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)