NCT06448455

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 3, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

Lung cancerFrailtyFactor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Sleep Quality

    First day of admission

  • Anxiety

    First day of admission

  • Depression

    First day of admission

Study Arms (1)

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.

Other: Observation

Interventions

Collect relevant data of patients

Lung cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 33538338BACKGROUND
  • 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.

    PMID: 30642458BACKGROUND
  • 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.

MeSH Terms

Conditions

Lung NeoplasmsFrailty

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Jing Wang

    Peking University Third Hospital Library

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head nurse

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

April 1, 2024

Primary Completion

July 1, 2024

Study Completion

December 31, 2024

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

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.

Locations