LUDICAS: Characteristics of Sexual Dysfunction in Patients With Lung Cancer

Sponsor

Fundación GECP (Other)

Overall Status

Recruiting

CT.gov ID

NCT06018376

Collaborator

(none)

500

Enrollment

Locations

8.6

Anticipated Duration (Months)

17.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Sexual Dysfunction	Drug: Systemic oncological 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Characteristics of Sexual Dysfunction in Patients With Lung Cancer

Actual Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

Arm	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: chemotherapy radiotherapy

Arm

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:

chemotherapy

radiotherapy

Outcome Measures

Primary Outcome Measures

Number of Participants with different type, frequency and severity of sexual dysfunction [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.

Secondary Outcome Measures

Number of participants with risk factors for the development and severity of sexual dysfunction. [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.
Number of participants with sexual dysfunction according to different characteristics [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Alexander Flemming	Buenos Aires		Argentina
2	Oncomedica, IMAT	Montería	Monteria	Colombia
3	Clínica Universitaria Colombia	Bogotá		Colombia
4	Clinica del Occidente	Cali		Colombia
5	Hematooncologos SA	Cali		Colombia
6	Clínica de Medellín	Medellín		Colombia
7	ALIADAS Instituto Nacional de Enfermedades Neoplasicas	Surquillo		Peru	15038
8	Centro Hospitalar do Porto	Porto		Portugal	4099-001
9	Hospital General de Elche	Elche	Alicante	Spain	03203
10	ICO Badalona, Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
11	Hospital General de Granollers	Granollers	Barcelona	Spain	08402
12	Hospital La Mancha Centro	Alcázar De San Juan	Ciudad Real	Spain	13600
13	Hospitalario Universitario A Coruña	A Coruña	La Coruña	Spain	15006
14	Hospital de Fuenlabrada	Fuenlabrada	Madrid	Spain	28942
15	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid	Spain	28222
16	Hospital Infanta Sofia	San Sebastián De Los Reyes	Madrid	Spain	28702
17	Hospital Universitario Cruces	Barakaldo	Vizcaya	Spain	48903
18	Hospital Universitari Vall d' Hebron	Barcelona		Spain	08035
19	Hospital General Universitario de Ciudad Real	Ciudad Real		Spain	13005
20	Hospital Universitario Lucus Augusti	Lugo		Spain	27003
21	Hospital Clínico San Carlos	Madrid		Spain	28040
22	Hospital Universitario Fundación Jiménez Díaz	Madrid		Spain	28040
23	Hospital Universitari Son Llatzer	Palma De Mallorca		Spain	07198
24	Hospital Clínico de Salamanca	Salamanca		Spain	37007
25	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife		Spain	38010
26	Xarxa sanitaria Santa Tecla- Tarragona	Tarragona		Spain	43003
27	Hospital General Universitario de Valencia	Valencia		Spain	46014
28	Hospital Universitario La Fe	Valencia		Spain	46026
29	Hospital Clínico Universitario de Valladolid	Valladolid		Spain	47003

Sponsors and Collaborators

Fundación GECP

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Fundación GECP

ClinicalTrials.gov Identifier:

NCT06018376

Other Study ID Numbers:

GECP 23/01_LUDICAS

First Posted:

Aug 30, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fundación GECP

Lung Cancer

Sexual Dysfunction

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Sep 1, 2023