Clinical trial NCT06018376: Characteristics of Sexual Dysfunction in Patients With Lung Cancer
Official title: Characteristics of Sexual Dysfunction in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Sexual Dysfunction
Keywords: Lung Cancer
Sexual Dysfunction
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 553
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung cancer stages IB to IV with ECOG ≤ 2 between 18 and 70 years old that received systemic oncological treatment for at least 3 months.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with different type, frequency and severity of sexual dysfunction
timeFrame: From inclusion up to 3 months
Secondary outcomes:
measure: Number of participants with risk factors for the development and severity of sexual dysfunction.
timeFrame: From inclusion up to 3 months
measure: Number of participants with sexual dysfunction according to different characteristics
timeFrame: From inclusion up to 3 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Flemming
city: Montería
country: Colombia
facility: Oncomedica, IMAT
state: Monteria
city: Bogotá
country: Colombia
facility: Clínica Universitaria Colombia
city: Cali
country: Colombia
facility: Clinica del Occidente
city: Cali
country: Colombia
facility: Hematooncologos SA
city: Medellín
country: Colombia
facility: Clínica de Medellín
city: Surquillo
country: Peru
facility: ALIADAS Instituto Nacional de Enfermedades Neoplasicas
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Elche
country: Spain
facility: Hospital General de Elche
state: Alicante
city: Badalona
country: Spain
facility: ICO Badalona, Hospital Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Alcázar De San Juan
country: Spain
facility: Hospital La Mancha Centro
state: Ciudad Real
city: A Coruña
country: Spain
facility: Hospitalario Universitario A Coruña
state: La Coruña
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Infanta Sofia
state: Madrid
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebron
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Llatzer
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Tarragona
country: Spain
facility: Xarxa sanitaria Santa Tecla- Tarragona
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Hospital Puerta del Hierro Investigator
name: Aylen Vanessa Ospina Serrano, MD
role: STUDY_CHAIR
References:
citation: Ospina-Serrano AV, Maximiano C, Cantos B, Torrente M, Mendez M, Sanchez JC, Calvo V, Collazo-Lorduy A, Blanco M, Nunez B, Triana I, Parejo C, Martinez P, Duma N, Provencio-Pulla M. Sexual dysfunction in patients with cancer, a challenge in oncology practice: results of the CLARIFY project. Clin Transl Oncol. 2024 May;26(5):1147-1156. doi: 10.1007/s12094-023-03332-0. Epub 2023 Nov 2.