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Sponsor decision due to the low recruitment rate
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| Name | Class |
|---|---|
| Pivotal S.L. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| male | It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. |
| |
| female | It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of gender differences on the psychosocial and economic impact. | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07010 | Spain | ||
| Hospital de Son Llàtzer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33228796 | Derived | 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. |
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| 2 years |
| Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact) | 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. | 2 years |
| Palma de Mallorca |
| Balearic Islands |
| 07198 |
| Spain |
| Hospital German Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Provincial de Castellón | Castellon | Castellón | 12006 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08026 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Clínico Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Arnau de Villanova | Valencia | 46015 | Spain |
| Hospital La Fe | Valencia | 46026 | Spain |
| Hospital Clínico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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