- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06448455
Observation on the Frailty Status of Lung Cancer Patients
Observation of Frailty in Lung Cancer Patients and Its Influencing Factors
Study Overview
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jing Wang
- Phone Number: 13699176380
- Email: nmwj0723@163.com
Study Contact Backup
- Name: Xinhua Shi
- Phone Number: 13699176380
- Email: shixinhua325@163.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100083
- Recruiting
- Peking University Third Hospital
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Principal Investigator:
- Jing Wang
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Contact:
- Jing Wang
- Phone Number: 13699176380
- Email: nmwj0723@163.com
-
Contact:
- Xinhua Shi
- Phone Number: 13699176380
- Email: shixinhua325@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Lung cancer patients
Through convenience sampling, lung cancer patients who were hospitalized and outpatients in the cancer chemotherapy Department of Peking University Third Hospital were selected as the research objects of this study.
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Collect relevant data of patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frailty
Time Frame: First day of admission
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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.
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First day of admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sleep Quality
Time Frame: First day of admission
|
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.
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First day of admission
|
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Anxiety
Time Frame: First day of admission
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Hospital Anxiety Scales,The scores range from 0 to 21.
The higher the score, the more serious the anxiety.
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First day of admission
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Depression
Time Frame: First day of admission
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Hospital Depression Scales,The scores range from 0 to 21.
The higher the score, the more serious the depression.
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First day of admission
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jing Wang, Peking University Third Hospital Library
Publications and helpful links
General Publications
- 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.
- 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.
- 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.2018.06.007. Epub 2018 Jul 10.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LM2024248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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