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

February 2, 2024 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

Recruiting

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 (Estimated)

500

Contacts and Locations

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

Study Contact

  • Name: Eva Pereira
  • Phone Number: +34 934302006
  • Email: gecp@gecp.org

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Not yet recruiting
        • Instituto Alexander Flemming
        • Contact:
          • Claudio Martín, MD
        • Principal Investigator:
          • Claudio Martín, MD
  • Colombia
      • Bogotá, Colombia
        • Not yet recruiting
        • Clínica Universitaria Colombia
        • Contact:
          • Pedro Ramos, MD
        • Principal Investigator:
          • Pedro Ramos, MD
      • Cali, Colombia
        • Not yet recruiting
        • Clinica del Occidente
        • Contact:
          • Giovanna Rivas, MD
        • Principal Investigator:
          • Giovanna Rivas, MD
      • Cali, Colombia
        • Not yet recruiting
        • Hematooncologos SA
        • Contact:
          • Ana Avendaño, MD
        • Principal Investigator:
          • Ana Avendaño, MD
      • Medellín, Colombia
        • Not yet recruiting
        • Clínica de Medellín
        • Contact:
          • Nathalia Arango, MD
        • Principal Investigator:
          • Nathalia Arango, MD
    • Monteria
      • Montería, Monteria, Colombia
        • Not yet recruiting
        • Oncomedica, IMAT
        • Contact:
          • Sandra Arauchan, MD
        • Principal Investigator:
          • Sandra Arauchan, MD
  • Peru
      • Surquillo, Peru, 15038
        • Not yet recruiting
        • ALIADAS Instituto Nacional de Enfermedades Neoplasicas
        • Contact:
          • Tanya Runciman, MD
        • Principal Investigator:
          • Tanya Runciman, MD
  • Portugal
      • Porto, Portugal, 4099-001
        • Not yet recruiting
        • Centro Hospitalar do Porto
        • Contact:
          • Antonio Araújo, MD
        • Principal Investigator:
          • Antonio Araújo, MD
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d' Hebron
        • Contact:
          • Augusto Valdivia, MD
        • Principal Investigator:
          • Augusto Valdivia, MD
      • Ciudad Real, Spain, 13005
        • Not yet recruiting
        • Hospital General Universitario de Ciudad Real
        • Principal Investigator:
          • Patricia Cruz, MD
        • Contact:
          • Patricia Patricia, MD
      • Lugo, Spain, 27003
        • Not yet recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Begoña Campos, MD
        • Principal Investigator:
          • Begoña Campos, MD
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Principal Investigator:
          • Manuel Dómine, MD
        • Contact:
          • Manuel Dómine, MD
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Mónica Antoñanzas Basa, MD
        • Principal Investigator:
          • Mónica Antoñanzas Basa, MD
      • Palma De Mallorca, Spain, 07198
        • Not yet recruiting
        • Hospital Universitari Son Llàtzer
        • Contact:
          • Juan Coves Sarto, MD
        • Principal Investigator:
          • Juan Coves Sarto, MD
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Hospital Clinico De Salamanca
        • Contact:
          • Alejandro Olivares Hernández, MD
        • Principal Investigator:
          • Alejandro Olivares Hernández, MD
      • Santa Cruz De Tenerife, Spain, 38010
        • Not yet recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
        • Contact:
          • Ana Cardeña Gutierrez, MD
        • Principal Investigator:
          • Ana Cardeña Gutierrez, MD
      • Tarragona, Spain, 43003
        • Recruiting
        • Xarxa sanitaria Santa Tecla- Tarragona
        • Principal Investigator:
          • Laia Capdevila, MD
        • Contact:
          • Laia Capdevila, MD
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario De Valencia
        • Contact:
          • Ana Blasco, MD
        • Principal Investigator:
          • Ana Blasco, MD
      • Valencia, Spain, 46026
        • Not yet recruiting
        • Hospital Universitario La Fé
        • Principal Investigator:
          • Francisco Aparisi, MD
        • Contact:
          • Francisco Aparisi, MD
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
        • Contact:
          • Rafael López, MD
        • Principal Investigator:
          • Rafael López, MD
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Not yet recruiting
        • Hospital General de Elche
        • Principal Investigator:
          • Maria Guirado Risueño, MD
        • Contact:
          • Maria Guirado Risueño, MD
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • ICO Badalona, Hospital Germans Trias i Pujol
        • Contact:
          • Pau Guillén Sentís, MD
        • Principal Investigator:
          • Pau Guillén Sentís, MD
      • Granollers, Barcelona, Spain, 08402
        • Not yet recruiting
        • Hospital General de Granollers
        • Contact:
          • Silvia Muñoz, MD
        • Principal Investigator:
          • Silvia Muñoz, MD
    • Ciudad Real
      • Alcázar De San Juan, Ciudad Real, Spain, 13600
        • Not yet recruiting
        • Hospital La Mancha Centro
        • Contact:
          • Sara Cerezo, MD
        • Principal Investigator:
          • Sara Cerezo, MD
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Not yet recruiting
        • Hospitalario Universitario A Coruña
        • Contact:
          • Rosario García Campelo, MD
        • Principal Investigator:
          • Rosario García Campelo, MD
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Recruiting
        • Hospital De Fuenlabrada
        • Contact:
          • María Sereno Moyano, MD
        • Principal Investigator:
          • María Sereno Moyano, MD
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
          • Vanessa Ospina, MD
        • Principal Investigator:
          • Vanessa Ospina, MD
      • San Sebastián De Los Reyes, Madrid, Spain, 28702
        • Not yet recruiting
        • Hospital Infanta Sofia
        • Contact:
          • María Sereno Moyano, MD
        • Principal Investigator:
          • María Sereno Moyano, MD
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Recruiting
        • Hospital Universitario Cruces
        • Contact:
          • Eider Azkona, MD
        • Principal Investigator:
          • Eider Azkona, MD

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

N/A

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 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 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.

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 (Estimated)

March 30, 2024

Study Completion (Estimated)

June 30, 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 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

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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