Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
Study NCT ID:
NCT06832592
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2025-02-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supportive Care Needs of Bronchial Cancer Patients in Active Treatment: A Descriptive Study in Outpatient Oncology
Sponsor:
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
Organization:
Study Overview
Official Title:
Etude Descriptive Des Besoins en Soins de Support Des Patients en Phase Active de Traitement d'un Cancer Bronchique en Oncologie Ambulatoire à l'hôpital Nord-Ouest de Villefranche/Saône.
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bronchial cancer is a major oncological pathology, representing the leading cause of cancer death in France. Supportive oncological care (SOS) is defined as all the care and support necessary for patients throughout their journey, in addition to specific treatments. Despite their importance, their identification and accessibility remain heterogeneous in outpatient oncology. This single-center observational study aims to describe the supportive care needs of patients with bronchial cancer in the active phase of treatment at the Nord-Ouest Hospital in Villefranche-sur-Saône. A self-questionnaire based on the national SOS identification grid will be offered to 100 patients followed in thoracic oncology. The main objective is to identify priority needs perceived and expressed by patients, particularly in terms of psychological support, pain management, nutrition, physical activity, fatigue and social impact. Secondary objectives include the evaluation of the proposal and acceptance of SOS by patients, the analysis of the causes of refusal and the study of variations in needs according to the temporality of treatments and demographic characteristics. A descriptive statistical analysis will be carried out, supplemented by comparative tests to explore the relationships between identified needs and patient profiles. The expected results will make it possible to optimize the provision of supportive care in outpatient oncology, by proposing strategies adapted to the specific needs of patients with bronchial cancer.
Detailed Description:
Bronchial cancer is a leading oncological pathology, representing the leading cause of cancer death in France. In 2023, there were 52,777 new cases, with a downward trend in men but a notable increase in women. Despite therapeutic advances, this pathology remains associated with high morbidity and a significant impairment of patients' quality of life. Supportive oncological care is defined as all the care and support necessary for patients throughout their journey, in addition to specific oncological treatments. The national framework for supportive oncological care (2021) highlights their essential role in improving the quality of life of patients with cancer, but their evaluation and proposal remain heterogeneous, particularly in outpatient oncology. In this context, this single-center observational study aims to describe the supportive care needs of patients with bronchial cancer in the active phase of treatment at the Nord-Ouest Hospital in Villefranche-sur-Saône.
A self-questionnaire inspired by the national grid for identifying supportive oncological care will be offered to 100 patients followed in thoracic oncology. The main objective is to identify priority supportive care needs, whether perceived by professionals or expressed directly by patients. This identification will concern several areas: understanding the disease and treatments, pain management, psychological support, nutrition, physical activity, fatigue, sleep, maintaining social and professional life, sexuality and lifestyle habits. The study will also focus on the supportive care actually offered and its acceptance by patients, in order to assess possible disparities between the needs identified and the existing offer.
Secondary objectives include the analysis of the causes of refusal of supportive care, the evaluation of patient satisfaction with the existing offer and the study of the influence of the temporality of treatments on the evolution of needs. The study will also seek to determine whether these needs vary based on certain demographic characteristics such as age and gender.
From a methodological point of view, the data will be analyzed using a descriptive and comparative approach. The results will be expressed in frequencies and percentages for qualitative variables, and in means or medians for quantitative variables. Appropriate statistical tests will make it possible to compare groups and identify factors influencing the variability of needs.
The study will take place over a period of one month, with inclusion planned for February 2025 and completion in March 2025. Each patient will participate in the study over a single day, corresponding to the completion of the self-questionnaire during an outpatient oncology consultation. The questionnaire will be distributed by the investigator and can be completed with the help of a caregiver if necessary.
The expected results will make it possible to optimize the provision of outpatient oncology supportive care, by identifying unmet needs and obstacles to access to this care. They could also contribute to the implementation of improvement strategies adapted to the specificities of patients with bronchial cancer, in order to ensure more complete and personalized care.
A self-questionnaire inspired by the national grid for identifying supportive oncological care will be offered to 100 patients followed in thoracic oncology. The main objective is to identify priority supportive care needs, whether perceived by professionals or expressed directly by patients. This identification will concern several areas: understanding the disease and treatments, pain management, psychological support, nutrition, physical activity, fatigue, sleep, maintaining social and professional life, sexuality and lifestyle habits. The study will also focus on the supportive care actually offered and its acceptance by patients, in order to assess possible disparities between the needs identified and the existing offer.
Secondary objectives include the analysis of the causes of refusal of supportive care, the evaluation of patient satisfaction with the existing offer and the study of the influence of the temporality of treatments on the evolution of needs. The study will also seek to determine whether these needs vary based on certain demographic characteristics such as age and gender.
From a methodological point of view, the data will be analyzed using a descriptive and comparative approach. The results will be expressed in frequencies and percentages for qualitative variables, and in means or medians for quantitative variables. Appropriate statistical tests will make it possible to compare groups and identify factors influencing the variability of needs.
The study will take place over a period of one month, with inclusion planned for February 2025 and completion in March 2025. Each patient will participate in the study over a single day, corresponding to the completion of the self-questionnaire during an outpatient oncology consultation. The questionnaire will be distributed by the investigator and can be completed with the help of a caregiver if necessary.
The expected results will make it possible to optimize the provision of outpatient oncology supportive care, by identifying unmet needs and obstacles to access to this care. They could also contribute to the implementation of improvement strategies adapted to the specificities of patients with bronchial cancer, in order to ensure more complete and personalized care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: