Clinical trial · Observational
Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer
Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.
NCT02336061CI-TRIAL-00030818IMPULSOterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision due to the low recruitment rate
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of gender differences on the psychosocial and economic impact. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- male
- description
- It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
- interventionNames
- Behavioral: Evaluation of gender differences on the psychosocial and economic impact.
- label
- female
- description
- It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts.
Primary outcomes (2)
- measure
- Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVinolas 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