Involvement of General Practitioners in Lung Cancer Screening

Обзор

The main objective is to evaluate the adherence of smoking patients to lung cancer screening by low-dose CT scan, when proposed by the general practitioner.

Подробное описание

Lung cancer is the leading cause of cancer mortality in France and worldwide. The KBP2020 study conducted in general hospitals, including 8999 patients diagnosed with lung cancer in the year 2020, showed that 73% of lung cancer cases were diagnosed at an advanced symptomatic stage, explaining the high rate of metastatic status at diagnosis, reaching 58%. For this category of patients, 3-month mortality remains very high, close to 25%. Several large randomized studies have demonstrated that lung cancer screening with low-dose CT scans enables lung cancer to be diagnosed at an early, asymptomatic stage, when it is mostly accessible to curative surgical treatment. This early detection and subsequent treatment reduced specific mortality by 20% in the NLST study, and by up to 39% at 10 years in the MILD study. Overall mortality was reduced by 6.7% in the NLST study. This scientific evidence has led the French National Authority for Health to encourage the implementation of a pilot program, to be organized by the French National Cancer Institute.

The hypothesis of the study is that the proposal of CT screening for lung cancer will be better adhered to if it is made by the general practitioner of individuals at risk. Adherence is defined by an initial scan, followed by a second scan one year after the first, with participation in screening on an annual basis.

Given the trust that generally characterizes the relationship between patients and their GP, and the fact that intercurrent consultations provide reminders of the need for an annual check-up, the assumption is for an initial participation rate of at least 50%, and a continued participation rate of 70% at 1 year.

Communication of results by the GP will help to limit anxiety, particularly in the event of an undetermined result, which will be assessed by the anxiety section of the Hospital Anxiety and Depression scale questionnaire translated into French.

In addition, the success of smoking cessation will be compared with literature data in the context of screening. The hypothesis is that the cessation rate will be higher due to the possibility of adapting nicotine substitution by the GP and his or her repeated support in the cessation process.

Finally, knowledge of patients' histories will help to limit unnecessary explorations and to better identify for which participants screening reveals COPD (emphysema), osteoporosis or unrecognized coronary artery disease.

Вмешательства

• Процедура Low-dose computed tomography of the chest
  Baseline low dose Ct acquisition, then at 1 year to depict suspicious lung nodules

Первичные конечные точки

• Rate of completion of screening scan [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Evolution of tobacco consumption [Срок оценки: 12 months]
• Evolution of anxiety [Срок оценки: 12 months]
• Chronic obstructive pulmonary disease (COPD) [Срок оценки: Up to 12 months]
• Statin/aspirin prevention [Срок оценки: Up to 12 months.]
• Osteoporosis [Срок оценки: Up to 12 months.]
• Other pathologies [Срок оценки: Up to 18 months]
• Cancer screened [Срок оценки: Up to 18 months]
• Characteristics of eligible population refusing screening : age [Срок оценки: Day 0]
• Characteristics of eligible population refusing screening : sex [Срок оценки: Day 0]
• Characteristics of eligible population refusing screening : smoking status [Срок оценки: Day 0]
• Characteristics of eligible population refusing screening : level of education [Срок оценки: Day 0]
• Characteristics of eligible population refusing screening : reason for refusal [Срок оценки: Day 0]

Критерии участия

Критерии включения

• Adults aged 50-74
• Active smoker or weaned smoker for less than 15 years, of at least 20 pack-years
• Affiliation with a social security scheme or CMU (beneficiary or beneficiary entitled)
• Written informed consent prior to study participation

Критерии исключения

• History of lung cancer
• Thoracic CT scan performed within the previous year
• 1-year follow-up not possible
• Inability to travel independently to Hôpital Cochin or Hôpital Bichat for scans
• People with severe co-morbidities contraindicating exploration and/or management of lung cancers
• People in poor general health (=PS2 and above)
• People with a history of cancer under active surveillance by thoracic computed tomography (CT and PET scans)
• People with rest dyspnea (=mMRC4)
• Recent weight loss, altered general condition or hemoptysis, raising suspicion of progressive lung cancer
• Signs of respiratory infection (fever, productive cough)
• Patients under guardianship, curatorship or protected adults
• Inability to give free written informed consent prior to study participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Hôpital Cochin — Paris

Публикации

• Rosell R, Gonzalez-Cao M. Ablating lung cancer, knowing the tumor better. Lancet Reg Health Eur. 2022 Aug 26;22:100494. doi: 10.1016/j.lanepe.2022.100494. eCollection 2022 Nov. No abstract available. PMID 36061495
• National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
• Pastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 2019 Jul 1;30(7):1162-1169. doi: 10.1093/annonc/mdz117. PMID 30937431
• de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized T PMID 31995683
• Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114. PMID 8717600
• From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke PMID 29773566
• Leleu O, Basille D, Auquier M, Clarot C, Hoguet E, Baud M, Lenel S, Milleron B, Berna P, Jounieaux V. Results of Second Round Lung Cancer Screening by Low-Dose CT scan - French Cohort Study (DEP-KP80). Clin Lung Cancer. 2022 Jan;23(1):e54-e59. doi: 10.1016/j.cllc.2021.09.009. Epub 2021 Oct 10. PMID 34764039
• Aubin-Auger I, Laouenan C, Le Bel J, Mercier A, Baruch D, Lebeau JP, Youssefian A, Le Trung T, Peremans L, Van Royen P. Efficacy of communication skills training on colorectal cancer screening by GPs: a cluster randomised controlled trial. Eur J Cancer Care (Engl). 2016 Jan;25(1):18-26. doi: 10.1111/ecc.12310. Epub 2015 Apr 6. PMID 25851842

Идентификаторы

NCT: NCT06956040 · APHP230811 · 2024-A00669-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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