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A Web-based Calculator Predicts Heterogeneous Frailty Trajectories

Sponsor
Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05982899
Collaborator
(none)
412
Enrollment
2
Locations
25
Actual Duration (Months)
206
Patients Per Site
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To explore the predictive factors of frailty trajectories and develop a web-based nomogram among gastric cancer survivors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aims of this study are to explore the predictive factors of frailty trajectories in gastric cancer patients more comprehensively based on the health ecology theory and to construct a clinically convenient web-based prediction calculator, so as to screen high-risk frailty elderly gastric cancer patients at an early stage in clinical practice, and thus to implement early interventions to improve the prognosis.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    412 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Web-based Calculator Predicts Heterogeneous Frailty Trajectories Among Elderly Gastric Cancer Survivors
    Actual Study Start Date :
    Mar 1, 2021
    Actual Primary Completion Date :
    Oct 1, 2022
    Actual Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. frailty trajectories [1 year]

      Frailty was measured by Tilburg frailty indicator (TFI) scale at discharge, one month, three months, six months and twelve months after surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • diagnosed with gastric cancer by endoscopy or pathology;

    • age ≥60 years old;

    • radical gastrectomy was proposed;

    • be able to communicate simply in writing and verbally.

    Exclusion Criteria:

    • combined with other sites of malignant tumors;

    • combined with severe heart, liver, lung, and renal insufficiency;

    • recent using hormones, immunosuppressants;

    • with physical disabilities.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xueyi Miao Nanjing Jiangsu China 211166
    2 Nanjing medical university Nanjing China

    Sponsors and Collaborators

    • Nanjing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xueyi Miao, Principal Investigator, Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT05982899
    Other Study ID Numbers:
    • 2020-273
    First Posted:
    Aug 9, 2023
    Last Update Posted:
    Aug 9, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xueyi Miao, Principal Investigator, Nanjing Medical University
    gastric cancer
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Frailty

    Study Results

    No Results Posted as of Aug 9, 2023