Characteristics of Sexual Dysfunction in Patients With Lung Cancer

NCT ID: NCT06018376

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

553 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2024-02-29

Brief Summary

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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

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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.

Conditions

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Lung Cancer Sexual Dysfunction

Keywords

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Lung Cancer Sexual Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Systemic oncological treatment

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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chemotherapy radiotherapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación GECP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aylen Vanessa Ospina Serrano, MD

Role: STUDY_CHAIR

Hospital Puerta del Hierro Investigator

Locations

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Instituto Alexander Flemming

Buenos Aires, , Argentina

Site Status

Oncomedica, IMAT

Montería, Monteria, Colombia

Site Status

Clínica Universitaria Colombia

Bogotá, , Colombia

Site Status

Clinica del Occidente

Cali, , Colombia

Site Status

Hematooncologos SA

Cali, , Colombia

Site Status

Clínica de Medellín

Medellín, , Colombia

Site Status

ALIADAS Instituto Nacional de Enfermedades Neoplasicas

Surquillo, , Peru

Site Status

Centro Hospitalar do Porto

Porto, , Portugal

Site Status

Hospital General de Elche

Elche, Alicante, Spain

Site Status

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital General de Granollers

Granollers, Barcelona, Spain

Site Status

Hospital La Mancha Centro

Alcázar de San Juan, Ciudad Real, Spain

Site Status

Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Site Status

Hospital de Fuenlabrada

Fuenlabrada, Madrid, Spain

Site Status

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Hospital Infanta Sofia

San Sebastián de los Reyes, Madrid, Spain

Site Status

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Site Status

Hospital Universitari Vall d' Hebron

Barcelona, , Spain

Site Status

Hospital General Universitario de Ciudad Real

Ciudad Real, , Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitari Son Llatzer

Palma de Mallorca, , Spain

Site Status

Hospital Clínico de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Xarxa sanitaria Santa Tecla- Tarragona

Tarragona, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitario La Fe

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

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Argentina Colombia Peru Portugal Spain

References

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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.

Reference Type RESULT
PMID: 37917247 (View on PubMed)

Related Links

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http://www.gecp.org

Web page of the sponsor where users can find more information about Fundación GECP studies

Other Identifiers

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GECP 23/01_LUDICAS

Identifier Type: -

Identifier Source: org_study_id