Observation on the Frailty Status of Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Observation of Frailty in Lung Cancer Patients and Its Influencing Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448455
• Other study ID #: LM2024248
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Peking University Third Hospital
• Contact: Jing Wang
• Phone: 13699176380
• Email: nmwj0723[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using the Integrated Conceptual Model of Frailty (ICMF) and Frailty Framework among Vulnerable Population (FFVP) as theoretical basis, the frailty status of lung cancer patients is described, and the physiological, psychological, and social frailty of lung cancer patients are comprehensively evaluated and analyzed. The influencing factors related to frailty are explored, in order to provide a basis for effective intervention research on lung cancer patients in the future.

Description:

The frailty of lung cancer patients is the result of multiple systems and factors, and its pathological and physiological changes include neuroendocrine disorders, malnutrition, sarcopenia, chronic inflammatory reactions, etc., accompanied by comorbidities and aging, and various factors promote the occurrence of frailty. Previous studies have found that older age, female gender, low education level, multiple drug use, smoking, lack of exercise, comorbidities, falls, sleep disorders, and anxiety and depression are the influencing factors of frailty in the elderly . When many domestic scholars study the frailty characteristics of elderly lung cancer patients, they have found that patients with advanced age, low BMI, divorce or widowhood, smoking, higher lung cancer staging, comorbidities with other diseases, multiple medications, poor nutrition, lower daily living ability, long disease course, depression, and lower red blood cells, albumin, and hemoglobin are more prone to frailty . In summary, lung cancer patients are at risk of frailty, with a high incidence and an impact on the occurrence of adverse health outcomes. The conclusions drawn from different studies regarding the incidence and measurement of frailty in lung cancer patients vary. The frailty of lung cancer patients is influenced by multiple factors, not only involving demographic and disease-related factors. At present, there is limited research both domestically and internationally, mainly focusing on the impact of frailty in lung cancer patients on adverse health outcomes. There is a lack of research on the current situation and related factors of frailty in lung cancer patients. Most studies have explored demographic and disease-related factors in lung cancer patients, with little involvement in other variables such as psychological and social factors. Given the significant importance of frailty intervention in improving the health status of lung cancer patients, it is necessary to comprehensively evaluate the frailty status and related factors of lung cancer patients. Therefore, this study intends to use the Integrated Conceptual Model of Frailty (ICMF) and Frailty Framework among Vulnerable Population (FFVP) as theoretical basis to describe the frailty status of lung cancer patients, comprehensively evaluate and analyze the physiological, psychological, and social frailty of lung cancer patients, and explore the influencing factors related to frailty, in order to provide a basis for effective intervention research on lung cancer patients in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Lung cancer was diagnosed by pathology or cytology;
• Age = 18 years;
• Be able to complete this questionnaire independently or under the guidance of the researcher;
• Informed consent and voluntary participation in this study.

Exclusion Criteria:

• Serious physical diseases (heart, lung, kidney and other important organ failure);
• Patients with a history of dementia, mental illness, intellectual disability, and cognitive impairment;
• Blind, deaf and aphasic patients;
• Participate in other studies.

Related Conditions & MeSH terms

• Frailty
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Observation
Collect relevant data of patients

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Duan L, Cui H, Zhang W, Wu S. Symptoms and experiences of frailty in lung cancer patients with chemotherapy: A mixed-method approach. Front Oncol. 2022 Oct 6;12:1019006. doi: 10.3389/fonc.2022.1019006. eCollection 2022. — View Citation

Komici K, Bencivenga L, Navani N, D'Agnano V, Guerra G, Bianco A, Rengo G, Perrotta F. Frailty in Patients With Lung Cancer: A Systematic Review and Meta-Analysis. Chest. 2022 Aug;162(2):485-497. doi: 10.1016/j.chest.2022.02.027. Epub 2022 Feb 22. — View Citation

Ruiz J, Miller AA, Tooze JA, Crane S, Petty WJ, Gajra A, Klepin HD. Frailty assessment predicts toxicity during first cycle chemotherapy for advanced lung cancer regardless of chronologic age. J Geriatr Oncol. 2019 Jan;10(1):48-54. doi: 10.1016/j.jgo.2018 — View Citation

Shi JF, Wang L, Wu N, Li JL, Hui ZG, Liu SM, Yang BY, Gao SG, Ren JS, Huang HY, Zhu J, Liu CC, Fan JH, Zhao SJ, Xing PY, Zhang Y, Li N, Lei WD, Wang DB, Huang YC, Liao XZ, Xing XJ, Du LB, Yang L, Liu YQ, Zhang YZ, Zhang K, Qiao YL, He J, Dai M; LuCCRES Group. Clinical characteristics and medical service utilization of lung cancer in China, 2005-2014: Overall design and results from a multicenter retrospective epidemiologic survey. Lung Cancer. 2019 Feb;128:91-100. doi: 10.1016/j.lungcan.2018.11.031. Epub 2018 Nov 24. — View Citation

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty	Filburg Frailty Indicator,The score range is 0-55 points, and patients with = 2points are diagnosed as debilitated. The higher the score of the total scale, the more serious the weakness.	First day of admission
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index,The total score in the table ranges from 0 to 21 points. The higher the score, the worse the sleep quality.	First day of admission
Secondary	Anxiety	Hospital Anxiety Scales,The scores range from 0 to 21. The higher the score, the more serious the anxiety.	First day of admission
Secondary	Depression	Hospital Depression Scales,The scores range from 0 to 21. The higher the score, the more serious the depression.	First day of admission