Lung CarcinomaNCT06832592
Supportive Care Needs of Bronchial Cancer Patients in Active Treatment: A Descriptive Study in Outpatient Oncology
An observational study of Lung Carcinoma, run by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to 28 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient suffering from lung cancer and followed in the outpatient oncology department of the HNOV
Who may be able to join
- Patient with bronchial cancer in the active phase of treatment followed in the Ambulatory Oncology department of HNO Villefranche sur Saône.
- Major
- Knowing how to read and write French
- Affiliate to a Social Security scheme
Who cannot join
- Patient with cognitive disorder(s)
- Person under guardianship, curatorship or legal protection
- Patient objecting to participation
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Lung Carcinoma
- Keywords
- Lung cancer, Supportive oncological care, Patient needs, Self-questionnaire
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SOS-LUNG | population of 100 adults followed in the outpatient oncology department for lung cancer who are given a self-questionnaire on their need for supportive care after delivery of an information notice and collection of their non-opposition, over the period from February to April 2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Reporting Unmet Supportive Care Needs Using a Standardized Identification Grid.
Assessment of supportive care needs in patients with bronchial cancer using a standardized first-level identification grid. Needs will be categorized (e.g., psychological, nutritional, pain management, social support) and reported as the proportion of patients identifying at least one unmet need in each category.
Measured: At the time of outpatient consultation (Day 0)
Secondary outcomes (2)
Evaluate whether supportive care is offered by the healthcare team and accepted by patients.
Binary judgment criteria (yes/no) to additional questions added to the INCA reference grid
Measured: At the time of outpatient consultation (Day 0)
Analyze the causes of refusal of help by patients and evaluate the satisfaction of the supportive care offer
Answers to questions about the benefit of meeting a professional; managing the situation without help; sufficient advice and open responses and the rate of "unsatisfied" patient responses less than 5%
Measured: At the time of outpatient consultation (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start10 Feb 2025
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ODIER LUC, Lung Doctor, Study director, Hôpitaux Nord-Ouest Villefranche Sur Saône
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832592
- Sponsor's protocol ID
- HNO24_001
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: compliance with the regulations of the Data Protection Act, no transfer to the EU to respect the commitment to conform to the CNIL reference methodology MR-03.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06832592
- Acronym / sponsor ID
- HNO24_001
- Conditions
- Lung Carcinoma
- Keywords
- Lung cancer, Supportive oncological care, Patient needs, Self-questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- L'hôpital Nord-Ouest - Villefranche Villefranche sur SaôneUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOS-LUNG | – | –population of 100 adults followed in the outpatient oncology department for lung cancer who are given a self-questionnaire on their need for supportive care after delivery of an information notice and collection of their non-opposition, over the period from February to April 2025. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient suffering from lung cancer and followed in the outpatient oncology department of the HNOV
Key inclusion criteria (4 listed)
- Patient with bronchial cancer in the active phase of treatment followed in the Ambulatory Oncology department of HNO Villefranche sur Saône.
- Major
- Knowing how to read and write French
- Affiliate to a Social Security scheme
Key exclusion criteria (3 listed)
- Patient with cognitive disorder(s)
- Person under guardianship, curatorship or legal protection
- Patient objecting to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients Reporting Unmet Supportive Care Needs Using a Standardized Identification Grid.
Time frame: At the time of outpatient consultation (Day 0)
Assessment of supportive care needs in patients with bronchial cancer using a standardized first-level identification grid. Needs will be categorized (e.g., psychological, nutritional, pain management, social support) and reported as the proportion of patients identifying at least one unmet need in each category.
2 secondary outcomes
Evaluate whether supportive care is offered by the healthcare team and accepted by patients.
Time frame: At the time of outpatient consultation (Day 0)
Analyze the causes of refusal of help by patients and evaluate the satisfaction of the supportive care offer
Time frame: At the time of outpatient consultation (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Undecided. compliance with the regulations of the Data Protection Act, no transfer to the EU to respect the commitment to conform to the CNIL reference methodology MR-03.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ODIER LUC, Lung Doctor study director
Hôpitaux Nord-Ouest Villefranche Sur Saône
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Carcinoma, run by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Reporting Unmet Supportive Care Needs Using a Standardized Identification Grid. (time frame: At the time of outpatient consultation (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.