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CompletedNCT06832592Updated Apr 8, 2025

Supportive Care Needs of Bronchial Cancer Patients in Active Treatment: A Descriptive Study in Outpatient Oncology

An observational study in Lung Carcinoma, sponsored by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Lung Carcinoma

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Keywords

  • Lung cancer
  • Supportive oncological care
  • Patient needs
  • Self-questionnaire
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patient suffering from lung cancer and followed in the outpatient oncology department of the HNOV

Inclusion criteria

  1. Patient with bronchial cancer in the active phase of treatment followed in the Ambulatory Oncology department of HNO Villefranche sur Saône.
  2. Major
  3. Knowing how to read and write French
  4. Affiliate to a Social Security scheme

Exclusion criteria

Exclusion Criteria:

  1. Patient with cognitive disorder(s)
  2. Person under guardianship, curatorship or legal protection
  3. Patient objecting to participation
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the time of outpatient consultation (Day 0)

Secondary outcomes

  1. 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

    Time frame: At the time of outpatient consultation (Day 0)

  2. 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%

    Time frame: At the time of outpatient consultation (Day 0)

06

Study locations

1 site
  • HNO Villefranche
    Gleize, 69400, France
07

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06832592
Lead sponsor
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
Responsible party
Sponsor
First posted
Feb 18, 2025
Start date
Feb 10, 2025
Primary completion
Mar 28, 2025
Completion
Mar 28, 2025
Last update
Apr 8, 2025

Study contacts

ODIER LUC, Lung Doctor
study director · Hôpitaux Nord-Ouest Villefranche Sur Saône

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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