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NCT06018376 Clinical Trial

Characteristics of Sexual Dysfunction in Patients With Lung Cancer

Lung Cancer Clinical Trial

— LUDICAS  

Official title:
Characteristics of Sexual Dysfunction in Patients With Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06018376
Other study ID # GECP 23/01_LUDICAS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 13, 2023
Est. completion date February 29, 2024

Study information
Verified date May 2024
Source Fundación GECP
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. The recruitment will be carried out from July 2023 and will be carried out until December 2023, the analysis of the information will be carried out from January to March 2024.

Description:

It is planned to develop a study with a larger number of patients with lung cancer, including the population of Spain and Latin American countries to obtain a sample of more diverse and heterogeneous characteristics, with clinical, cultural, and sociodemographic differences. This will make it possible to obtain better and greater data and therefore define the clinical and treatment factors significantly associated with DS in these individuals and obtain a more complete vision of the reality of the problem. The results of this research will make it possible to carry out interventions specifically directed at this population and to modify the oncological follow-up guidelines currently in force. Likewise, the information collected will serve as the basis for generating new protocols for a multidisciplinary approach, including the participation of psychology and specialists in urology, gynecology, and psychiatry. The general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. The recruitment will be carried out from July 2023 and will be carried out until December 2023, the analysis of the information will be carried out from January to March 2024.

Recruitment information / eligibility
Status Completed
Enrollment 553
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Age greater than or equal to 18 years and less than or equal to 70 years. - Diagnosis of lung cancer stages IB to IV. - Having received systemic oncological treatment for at least 3 months or being in oncological follow-up after having received systemic treatment for a minimum of 3 months with stable tumor disease or partial or complete response in images. - ECOG = 2 Exclusion Criteria: - Patients with comorbidities (renal failure, cardiovascular diseases or similar) not controlled with corresponding medical management. - Individuals with physical disability or cognitive impairment that prevents them from completing the electronic data collection form.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Systemic oncological treatment
Oncological systemic treatment for at least 3 months or being in oncological follow-up after having received systemic treatment for a minimum of 3 months

Locations
Country Name City State
Argentina Instituto Alexander Flemming Buenos Aires
Colombia Clínica Universitaria Colombia Bogotá
Colombia Clinica del Occidente Cali
Colombia Hematooncologos SA Cali
Colombia Clínica de Medellín Medellín
Colombia Oncomedica, IMAT Montería Monteria
Peru ALIADAS Instituto Nacional de Enfermedades Neoplasicas Surquillo
Portugal Centro Hospitalar do Porto Porto
Spain Hospitalario Universitario A Coruña A Coruña La Coruña
Spain Hospital La Mancha Centro Alcázar De San Juan Ciudad Real
Spain ICO Badalona, Hospital Germans Trias i Pujol Badalona Barcelona
Spain Hospital Universitario Cruces Barakaldo Vizcaya
Spain Hospital Universitari Vall d' Hebron Barcelona
Spain Hospital General Universitario de Ciudad Real Ciudad Real
Spain Hospital General de Elche Elche Alicante
Spain Hospital de Fuenlabrada Fuenlabrada Madrid
Spain Hospital General de Granollers Granollers Barcelona
Spain Hospital Universitario Lucus Augusti Lugo
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Madrid
Spain Hospital Universitari Son Llatzer Palma De Mallorca
Spain Hospital Clínico de Salamanca Salamanca
Spain Hospital Infanta Sofia San Sebastián De Los Reyes Madrid
Spain Hospital Universitario Nuestra Señora de Candelaria Santa Cruz De Tenerife
Spain Xarxa sanitaria Santa Tecla- Tarragona Tarragona
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Universitario La Fe Valencia
Spain Hospital Clínico Universitario de Valladolid Valladolid

Sponsors (1)
Lead Sponsor Collaborator
Fundación GECP

Countries where clinical trial is conducted

Argentina,  Colombia,  Peru,  Portugal,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with different type, frequency and severity of sexual dysfunction Identify and describe the type, frequency, and severity of DS in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. From inclusion up to 3 months
Secondary Number of participants with risk factors for the development and severity of sexual dysfunction. Analysis of risk factors for the development and severity of sexual dysfunction described in the clinical history and study questionnaires. From inclusion up to 3 months
Secondary Number of participants with sexual dysfunction according to different characteristics To characterize the differences in sexual dysfunction in patients with lung cancer according to age, sociodemographic characteristics, region of residence, and type of cancer treatment. From inclusion up to 3 months
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