Characteristics of Sexual Dysfunction in Patients With Lung Cancer
Conditions: Lung Cancer, Sexual Dysfunction
Sponsor: Fundación GECP

Protocol_LUDICAS_GECP 18/03_ML40237_v.2.0_07Jun2023 
 
 
 
 
 
Official Title: “Characteristics of Sexual Dysfunction in Patients with Lung 
Cancer” Ibero- American Study” LUDICAS 
 
 
 
 
       NCT Number:  NCT06018376 
 
 
Document Dates:  
Protocol Version v.2.0_07Jun2023 
 
 

 
Protocol LUDICAS_GECP 23/01_v2.0_07June2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
"Characteristics of Sexual Dysfunction in Patients with 
Lung Cancer" 
 
 
 
 
 
 
 
LUDICAS Ibero-American Study 
 
 
 
 
Promoter: GECP Foundation 
Protocol code: GECP 23/01 
 
V2.0 of June 7, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Protocol LUDICAS_GECP 23/01_v2.0_07June2023  
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1. Project description 
 
Characteristics of Sexual Dysfunction in Patients with Lung Cancer. 
 
2. Promoter and protocol code 
 
Promoter: GECP Foundation 
 
Protocol code: GECP 23/01 
 
Version: v2.0 of 01 June 2023 
 
3. Principal Investigator and Project Coordinator 
 
 
Aylen, Vanessa Ospina, Serrano, MD. Clinical oncology. 
PhD Student, Medicine, Universidad Autónoma de Madrid. 
Medical Oncology Service Researcher 
Puerta de Hierro Health Research Institute - Segovia de Arana 
Puerta de Hierro Majadahonda-Madrid University Hospital 
 
Co-researchers at HUPHM 
• Virginia Calvo de Juan MD, PhD. Medical Oncologist. Hospital 
Puerta de Hierro-Majadahonda University, Madrid. Spain. 
• Ana Collazo-Lorduy MD, PhD. Medical Oncologist.University Hospital 
Puerta de Hierro-Majadahonda, Madrid. Spain. 
• Mariola Blanco MD. Medical Oncologist.Hospital Universitario Puerta de 
Hierro-Majadahonda, Madrid. Spain. 
• Mariano Provencio-Pulla MD, PhD. Medical Oncologist. Head of Service 
Medical Oncology. Puerta de Hierro-Majadahonda University Hospital, 
Madrid. Spain 
 
4. Qualifications and experience of the team of researchers and, where 
appropriate, of the person responsible for the medical care of the 
participants 
 
 
Since 2020, the CLARIFY project (monitoring of long cancer survivors using 
artificial intelligence) was initiated at the Puerta de Hierro University Hospital, 
previously approved by the ethics committee of  
investigation of the Puerta de Hierro University Hospital on 09/03/2020 (Minutes 
no. 5/2020). This research is led by Dr. Mariano Provencio and tells  
with the participation of the team of medical oncologists and the staff of the 
research center of the Puerta de Hierro hospital. 
 
 
 

 
 
 
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The project was planned to be developed over 3 years until 2023, divided into 3 
phases, the two initial phases with the aim of collecting information to identify 
the clinical, pathological and molecular characteristics of the disease, as well as 
the acute effects of cancer treatments and the evaluation of their efficacy 
through the monitoring of the most relevant clinical outcomes such as survival 
and identification of risk factors for recurrence tumor. While the third phase is 
aimed at evaluating the long-term effects on the quality of life of patients, 
including the alteration of sexual function.   
 
Within the third phase of the project, between May 2020 and May 2022, data 
were obtained from 383 long-term patients survivors of lung, breast and 
lymphoma cancer. The initial findings obtained on the alterations in the quality 
of life of these patients showed a high frequency of sexual dysfunction (SD) in 
this population, influenced by age, type of cancer and type of cancer treatment.  
 
These initial results served as a basis for generating additional hypotheses. 
They were presented as oral communication at the congress of the Spanish 
Society of Medical Oncology on October 18, 2022 and accepted to be 
presented at the poster session of the annual congress of the American Society 
of Clinical Oncology ASCO on June 5, 2023. 
 
Experience of the group of researchers in projects led by Dr Mariano 
Provencio: 
 
- 
IPT-2011-1569-01000. Valorization of oncological biomarkers for the 
development of diagnostic/prognostic kits for prostate and lung cancer 
- 
PI13/01806. Image Re-Analysis Study and Correlation Between 
Metabolic Changes Targeted by PET/CT and Known Mutations in Non-
Small Cell Lung Cancer (NSCLC) 
- 
PI18/01778. "Predictive Value of Treatment Response of CB2 
Expression in Colon Cancer" (Co-PI) 
- 
H2020-SC1-2016-2017 (Personalized Medicine). IASIS. Integration and 
analysis of heterogeneous big data for precision medicine and suggested 
treatments for different types of patients. 
- 
RTC-2017-6502-1. 
INmunoSIGHT- 
Immunological 
and 
molecular 
characterization in liquid biopsy of patients with lung cancer for 
immunotherapy. 
- 
H2020-875160 CLARIFY. Cancer Long Survivors Artificial Intelligence 
Follow up.  
- 
P4 LUCAT. Personalized medicine for lung cancer treatment: using Big 
Data-driven approaches for decision support. 
 
 
 
 
 

 
 
 
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Experience of the principal investigator: 
 
- 
H2020-875160 CLARIFY. Cancer Long Survivors Artificial Intelligence 
Follow up. 
 
- 
P4LUCAT. Personalized medicine for lung cancer treatment: using Big 
Data-driven approaches for decision support. 
 
- 
Author and principal investigator of the national registry of the Colombian 
Association of Hematology and Oncology ACHO of patients with cancer 
and Covid 19 infection (ACHOC-C19). 2020-2022. 
 
- 
Author and principal investigator of the Epidemiological Registry of 
Malignant Melanoma in Colombia (REMMEC) of the Colombian 
Association of Hematology and Oncology ACHO. 2021- present. 
 
 
5.  Funding 
 
The financing of the project will be supported by the promoter of the study, the 
GECP Foundation. 
 
 
6. Objective and justification of the research based on the most up-to-
date review of the available scientific evidence. 
 
Theoretical framework 
 
The population of cancer survivors may suffer long-term alterations secondary 
to antineoplastic treatments that lead to the deterioration of their quality of life 
and that include the generation of sexual dysfunction (SD).  
 
Most of the data on SD in cancer patients come from patients with breast 
cancer, gynecologic neoplasms, and prostate cancer, most of whom receive 
hormonal cancer treatments and cytotoxic chemotherapy, and have often 
undergone mutilating cancer surgeries. 
 
There are limited prospective studies carried out with heterogeneous collection 
instruments, which does not allow obtaining adequate and complete information 
on the real situation of the problem. 
 
 
 
 
 
 
 

 
 
 
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As a source of local data, there is a study to characterize sexual dysfunction in 
a cohort of cancer survivor patients derived from the European CLARIFY H2020 
project (Cancer Long Survivor Artificial Intelligence Follow-Up) that we carried 
out at the Puerta de Hierro University Hospital from May 2020 to May 2022.  
A total of 383 patients were included, distributed according to diagnosis in 
breast cancer 68.1% (261), lung cancer 26.3% (101) and lymphomas 5.48% 
(21).   
Globally, 69% of men vs. 31% of women reported being sexually active and 
76% of women vs. 24% of men had general sexual dissatisfaction. 
 
In our study, the largest sample of patients was women with breast cancer 
(261), which corresponds to the highest overall frequency reported in the 
literature of this type of neoplasm. 
In relation to the stage, patients with early breast cancer treated and followed 
up receiving hormonal therapy showed a greater tendency to suffer moderate 
disorders of the phases of sexual response, while patients with a diagnosis time 
greater than 5 years showed a tendency to not present alterations. Statistically 
significant associations were confirmed in patients with metastatic breast cancer 
to present severe disorders of the phases of sexual response. 
 
Regarding the specific characteristics of patients with lung cancer, which 
represented a smaller sample size (101), 66.3% (67) were men, the median age 
was 64 and 61 years in men and women respectively. 45% of women and 41% 
of men reported being sexually active. The absolute frequency of overall sexual 
dissatisfaction was 8.8% in men vs. 2.8 in women.  
Men showed a tendency to develop severe alterations in the phases of sexual 
response. On the other hand, a statistically significant association was 
evidenced for severe sexual response disorders in women. Of these, 35.2% 
received chemotherapy, 26.4% immunotherapy and 20.5% targeted therapies.  
 
When looking for similar information in the literature, we found previous 
research in women with lung cancer that supports that 95% of these patients 
score below the 50th percentile when rating their sexual function and a 2022 
study, in which 64% had metastatic disease, and almost half were receiving 
targeted therapy,  finding that 77% reported moderate to severe sexual 
dysfunction. 
 
Our data obtained in patients with lung cancer, despite representing a small 
sample size, suggest that SD is an alteration that is significantly affecting the 
quality of life of this population.  
 
 
 
 
 
 
 

 
 
 
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In addition, they suggest that there is a potential role for new cancer treatments 
such as targeted therapy and immune checkpoint inhibitors in the development 
of DS, for which there is limited information 
 
 
Justification 
 
Given the increase in lung cancer survivors and the therapeutic options different 
from those historically described as associated with DS, added to the fact that 
the patient profile has changed in recent years, with the male gender remaining 
the most affected, but with a significant increase in diagnosis in women and 
younger and non-smoking patients; it is important to characterize SD in this 
population and determine its severity as well as the associated risk factors and 
the role of new antineoplastic therapies. 
This knowledge will make it possible to propose strategies for approaching and 
monitoring cancer that help improve the quality of life of these patients during 
and after cancer treatments. 
 
A study is planned to be carried out 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 allow us to obtain better 
and greater data and consequently to define the clinical and treatment factors 
significantly associated with SD in these individuals and to obtain a more 
complete view of the reality of the problem. 
 
The results of this research will make it possible to carry out interventions 
specifically aimed at this population and modify the oncological follow-up 
guidelines currently in force. Likewise, the information collected will serve as a 
basis for generating new protocols for a multidisciplinary approach including the 
participation of psychology and specialists in urology, gynecology and 
psychiatry. 
 
Additionally, the knowledge obtained will allow to generate education about SD 
to the entire treating medical team and patients to overcome the barriers that 
prevent adequately addressing this condition.   
 
7. General Objective 
 
To identify and describe the type, frequency, and severity of SD in patients with 
lung cancer and to generate targeted clinical approach and oncological follow-
up strategies based on specific findings in this population. 
 
 
 
 
 

 
 
 
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8. Secondary Objectives 
 
• Describe the clinical, cultural, and sociodemographic characteristics of 
the study population. 
• To characterize differences in sexual dysfunction in patients with lung 
cancer according to age, sociodemographic characteristics, region of 
residence, and type of cancer treatment. 
• Identify risk factors for the development and severity of sexual 
dysfunction. 
• To promote education and awareness among the health team on the 
identification and characteristics of sexual dysfunction in patients with 
lung cancer. 
• To 
collect 
information 
to 
generate 
recommendations 
for 
the 
multidisciplinary approach and management of sexual dysfunction during 
oncological follow-up applicable to current oncology practice. 
• To propose education strategies on the management of sexual 
dysfunction in patients with lung cancer aimed at patients and their 
families. 
• To generate a collaborative network of Ibero-American research. 
 
 
9. Methods and procedures envisaged, including statistical and other 
analytical tests 
 
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. 
Clinical and demographic variables (Annex 1) will be collected by the treating 
oncologists and recorded in an electronic data collection notebook designed for 
this study, which will be accessed through a personal username and password. 
 
Data anonymization will be ensured for all patients. To this end, they will identify 
themselves with a numerical code in order to respect the confidentiality of 
personal data. The patient's initials and medical record number will be 
separated from the rest of the data and will not be included in the study 
database. 
 
Measurements of sexual function will be performed through an electronic survey 
that will be sent to patients who agree to participate in the study and sign the 
informed consent. This electronic survey will be hosted on an exclusive study 
platform, which the patient will enter through a user corresponding to the 
anonymization numerical code and a personal password assigned after signing 
the informed consent.  
 
 
 

 
 
 
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The survey will consist of single-choice questions based on two validated 
questionnaires to explore and diagnose sexual dysfunction in women (FSM) 
and men (FSH) separately, which have been evaluated and translated into 
Spanish by a local research group in the Valencian Community and are 
available for use in the primary care setting in Spain. These instruments were 
selected because of the possibility of self-administration, their history of efficacy 
in assessing complete sexual function in the general population, and their low 
level of complexity. Through this instrument, criteria of the phases of sexual 
response according to DSM V (FSH) and DSM IV (FSM) will be evaluated, as 
well as a descriptive parameter of sexual activity. (Appendices 2 and 3) 
 
The information entered by patients will only be visible by the principal 
investigator, who will have a personal username and password to access the 
data. 
 
10. Statistical analysis  
 
A descriptive analysis of the variables will be carried out; for the characteristics 
a univariate analysis. The qualitative variables will be determined with absolute 
and relative frequencies and the quantitative variables by measures of central 
tendency and dispersion, with mean and standard deviation for those with 
normal and median distribution and interquartile range for those with non-
normal distribution. Subsequently, an inferential analysis will be performed, with 
chi2 distribution to evaluate the correlations between the different variables and 
the main outcomes in the measurement of sexual function.  
Possible trends in association between variables and outcomes will be 
evaluated and the main trends described will be carried out through a 
multivariate analysis.  
Logistic regression analyses will be performed to determine risk factors 
Statistical analyses will be carried out using the SPSS Statistics 20 or R 
program. 
 
11. Full project overview in understandable language 
 
The population of cancer survivors may suffer long-term alterations secondary 
to antineoplastic treatments that lead to the deterioration of their quality of life 
and that include the generation of sexual dysfunction (SD). Most of the data on 
SD in cancer patients come from patients with breast cancer, gynecologic 
neoplasms, and prostate cancer, most of whom receive hormonal cancer 
treatments and cytotoxic chemotherapy.  
 
According to data from recent institutional research on the characteristics of SD 
in cancer survivors, it was documented that patients with lung cancer have a 
high frequency of DS, which is significantly affecting their quality of life.    
 
 
 

 
 
 
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Given the increase in survivors of this type of neoplasm and the fact that the 
patient profile has changed in recent years with a significant increase in 
diagnosis in women and younger and non-smoking patients; In addition to the 
fact that cancer treatment is different from that usually related to SD generation, 
it is of great importance to characterize SD in this population and determine its 
severity as well as the associated risk factors and the role of new antineoplastic 
therapies. 
This knowledge will make it possible to propose strategies for approaching and 
monitoring cancer that help improve the quality of life of these patients during 
and after cancer treatments. 
Likewise, the information collected will serve as a basis for generating new 
protocols for a multidisciplinary approach and will generate education about SD 
for the entire treating medical team as well as for patients and their families. 
 
12. Participants, Consent and Information 
 
 
12.1  Justification for the involvement of human beings in the research 
project 
 
Due to the observational nature of the study, there is no possibility that the 
study will generate any type of risk in the subjects studied, since it does not 
imply any change in the patient's care with respect to their normal clinical follow-
up. The research protocol will be submitted for approval by the research ethics 
committees (CEIC) of the participating institutions. 
 
Prior to the commencement of the study, the protocol, clinical information 
questionnaire, patient information sheet, and informed consent for the study will 
also be submitted for approval by the Clinical Research Ethics Committee 
(CEIC). . 
Patients who meet all inclusion criteria and give informed consent will be 
recruited. Each subject invited to participate in the study will be given a written 
document called a "Patient Information Sheet" that will contain the relevant 
information necessary for them to decide if they want to participate in the study. 
The investigator will inform the patient as fully as possible of the details of the 
study. Participating subjects may withdraw their consent to the use of their data 
in the analysis at any time, without giving a reason and without incurring any 
liability or loss. 
 
 
  
12.2 Criteria for the inclusion/exclusion of research participants 
 
 
 
 
 
 

 
 
 
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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. 
- 
Have received systemic cancer treatment for at least 3 months or be 
under cancer follow-up after having received systemic therapy for at least 
3 months with stable tumor disease or in partial or complete response on 
imaging.  
- 
ECOG ≤ 2 
 
Exclusion Criteria  
 
- 
Patients with comorbidities (kidney 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. 
 
 
12.3 Where applicable, method of randomization 
 
Not applicable. 
 
 
12.4 Study modality: open, single-blind or double-blind 
 
Analytical cross-sectional observational study.  
 
12.5 Deadlines and details of information for potential research 
participants, including proposed methods for communicating such 
information. 
 
Not applicable  
 
12.6Documentation, visual or other material to be used in the request for 
consent, or, in the case of persons unable to consent, for authorisation to 
participate in the research 
 
1. Patient information sheet that will contain the relevant and necessary 
information for the patient to decide if they want to participate in the 
study. (Annex 4) 
 
2. Informed consent (Annex 5), which each researcher must explain to the 
patient as completely as possible, specifying in understandable language 
the characteristics of the research project. 
 
 
 

 
 
 
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12.7 Provisions to ensure respect for the privacy of research participants 
and to ensure the confidentiality of personal data 
 
The study will be conducted in accordance with the Good Clinical Practice 
(GCP) Standards.  
The confidentiality of the data will be guaranteed in accordance with the 
provisions of Organic Law 3/2018, of 5 December, on the Protection of Personal 
Data and guarantee of digital rights and will separate personal clinical data in 
accordance with current legislation (Law 14/2007, of 3 July, on biomedical 
research).  
All patients' data will be anonymized. To this end, the patient will be identified 
by means of a numerical code in order to respect the confidentiality of the 
patients' personal data. The patient's initials and medical record number will be 
separated from the rest of the data, not included in the study database. 
Access to personal information will be restricted to the study investigators, the 
HUPHM clinical research ethics committee and specialized personnel 
authorized to verify the data and procedures of the study, always maintaining 
the confidentiality of the latter in accordance with current legislation. 
The informed consent will be written in Spanish and in understandable 
language. 
 
Subjects participating in the study may withdraw their consent to the use of their 
data in the analysis at any time, without giving a reason and without incurring 
any liability or loss. 
 
12.8 Forecasts for the processing of information that may be generated 
during research and of relevance to the present or future health of 
participants and members of their families 
 
The results of this research will serve as prospective local evidence of larger 
sample size on the characteristics of sexual dysfunction in the growing 
population of lung cancer survivors, who present a specific patient and 
treatment profile that is different from that of other cancer populations.  
This information will make it possible to define the clinical and treatment factors 
significantly associated with SD in these individuals and to obtain a more 
complete view of the reality of the problem. 
 
The data obtained will facilitate the implementation of interventions specifically 
aimed at this population and propose modifications to the oncological follow-up 
guidelines currently in force. Likewise, the information collected will serve as a 
basis for generating new protocols for a multidisciplinary approach, including 
psychology and specialists in urology, gynecology and psychiatry.  
 
 
 
 
 

 
 
 
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Additionally, education about SD can be generated for the entire treating 
medical team and for patients and their families to help overcome the barriers 
that prevent adequately addressing this condition and improve quality of life.   
 
12.9 Other Information 
 
The source of the clinical information of the patients, as well as of the 
pathological data, will be in all cases the patient's medical history. 
 
The information collected will be entered into the database and will be protected 
with an individual username and password for each researcher.