Characteristics of Sexual Dysfunction in Patients With Lung Cancer (LUDICAS)

February 5, 2026 updated by: Fundación GECP
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

553

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina
        • Instituto Alexander Flemming
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia
        • Clínica Universitaria Colombia
    • Cali
      • Cali, Cali, Colombia
        • Clinica del Occidente
      • Cali, Cali, Colombia
        • Hematooncologos SA
    • MEdellín
      • Medellín, MEdellín, Colombia
        • Clínica de Medellín
    • Monteria
      • Montería, Monteria, Colombia
        • Oncomedica, IMAT
  • Peru
    • Perú
      • Surquillo, Perú, Peru, 15038
        • ALIADAS Instituto Nacional de Enfermedades Neoplasicas
  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4099-001
        • Centro Hospitalar do Porto
  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General de Elche
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • ICO Badalona, Hospital Germans Trias i Pujol
      • Barcelona, Barcelona, Spain, 08035
        • Hospital Universitari Vall d' Hebrón
      • Granollers, Barcelona, Spain, 08402
        • Hospital General de Granollers
    • Ciudad Real
      • Alcázar de San Juan, Ciudad Real, Spain, 13600
        • Hospital La Mancha Centro
      • Ciudad Real, Ciudad Real, Spain, 13005
        • Hospital General Universitario de Ciudad Real
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Hospitalario Universitario A Coruña
    • Lugo
      • Lugo, Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital De Fuenlabrada
      • Madrid, Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • San Sebastián de los Reyes, Madrid, Spain, 28702
        • Hospital Infanta Sofía
    • Palma de Mallorca
      • Palma de Mallorca, Palma de Mallorca, Spain, 07198
        • Hospital Universitari Son Llàtzer
    • Salamanca
      • Salamanca, Salamanca, Spain, 37007
        • Hospital Clínico de Salamanca
    • Santa Cruz de Tenerife
      • Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
    • Tarragona
      • Tarragona, Tarragona, Spain, 43003
        • Xarxa sanitaria Santa Tecla- Tarragona
    • Valencia
      • Valencia, Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Valencia, Spain, 46026
        • Hospital Universitario la Fe
    • Valladolid
      • Valladolid, Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital Universitario Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational Study Group
  • 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
  • ECOG ≤ 2
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
Other Names:
  • radiotherapy
  • chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction
Time Frame: From inclusion up to 3 months
Identify and describe the type, frequency, and severity of sexual disfunction 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with risk factors for the development and severity of sexual dysfunction.
Time Frame: From inclusion up to 3 months
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
Number of participants with sexual dysfunction according to different characteristics
Time Frame: From inclusion up to 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación GECP

Investigators

  • Study Chair: Aylen Vanessa Ospina Serrano, MD, Hospital Puerta del Hierro Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2023

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 23/01_LUDICAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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