Lung CancerNCT06448455
Observation on the Frailty Status of Lung Cancer Patients
An observational study of Lung Cancer, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Observation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2024
- 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: This study will select lung cancer patients who are hospitalized and outpatients in the cancer chemotherapy Department of Peking University Third Hospital as the research object through convenient sampling.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
Jing Wang, 13699176380, nmwj0723@163.com
Xinhua Shi, 13699176380, shixinhua325@163.com
About this study
Official title: Observation of Frailty in Lung Cancer Patients and Its Influencing Factors
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Observation
- Keywords
- Lung cancer, Frailty, Factor
- Medical subject headings
- Lung Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Collect relevant data of patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First day of admission
Secondary outcomes (3)
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.
Measured: First day of admission
Anxiety
Hospital Anxiety Scales，The scores range from 0 to 21. The higher the score, the more serious the anxiety.
Measured: First day of admission
Depression
Hospital Depression Scales，The scores range from 0 to 21. The higher the score, the more serious the depression.
Measured: First day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jing, Peking University Third Hospital
- Investigators
- Jing Wang, Principal investigator, Peking University Third Hospital Library
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448455
- Sponsor's protocol ID
- LM2024248
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on reasonable request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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.
PubMed 33538338Shi 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.
PubMed 30642458Ruiz 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.
PubMed 30005982Komici 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.
PubMed 35217002Duan 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.
PubMed 36276107
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Frailty in Lung Cancer Patients and Its Influencing Factors
- ClinicalTrials.gov ID
- NCT06448455
- Acronym / sponsor ID
- LM2024248
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Frailty, Factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jun 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer patients | – | Other: ObservationThrough 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will select lung cancer patients who are hospitalized and outpatients in the cancer chemotherapy Department of Peking University Third Hospital as the research object through convenient sampling.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationCollect relevant data of patients | Other | Lung cancer patients |
Primary outcome
Frailty
Time frame: First day of admission
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.
3 secondary outcomes
Sleep Quality
Time frame: First day of admission
Anxiety
Time frame: First day of admission
Depression
Time frame: First day of admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Background: PubMed 33538338Sung 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.
- Background: PubMed 30642458Shi 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.
- Results publication: PubMed 30005982Ruiz 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.
- Results publication: PubMed 35217002Komici 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.
- Results publication: PubMed 36276107Duan 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.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on reasonable request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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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.
Jing Wang principal investigator
Peking University Third Hospital Library
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 Cancer, run by Peking University Third Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang (13699176380, nmwj0723@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: First day of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06448455, which also lists 5 linked publications.
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 10 Jun 2024.