NCT05793229

Brief Summary

Frailty is common in gastric cancer survivors and seriously affects their prognosis. Multiple longitudinal follow-up assessment of frailty could provide a better understanding of the frailty change of individuals. Our aims were to identify the longitudinal trajectories of frailty and estimate their association with health outcomes in elderly gastric cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

March 19, 2023

Last Update Submit

March 19, 2023

Conditions

Frailty Syndrome

Outcome Measures

Primary Outcomes (4)

  • quality of life (QOL)

    used EORTC QLQ-STO22 to assess.

    at 1-year after surgery

  • disability

    used Elderly Disability Assessment Scale to assess.

    at 1-year after surgery

  • 1-year hospital readmissions

    captured from medical records.

    at 1-year after surgery

  • total costs

    captured from medical records.

    at 1-year after surgery

Study Arms (3)

improving frailty

Class 1

Other: observation

maintaining frailty

Class 2

Other: observation

deteriorating frailty

Class 3

Other: observation

Interventions

observationOTHER

observation

deteriorating frailtyimproving frailtymaintaining frailty

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients with gastric cancer who attended a tertiary care hospital in China from March 2021 to October 2021 were selected for the study.

You may qualify if:

  • diagnosed with gastric cancer by endoscopy or pathology;
  • received radical gastrectomy the first time;
  • aged ≥60 years;
  • been able to communicate simply in writing and verbal;
  • completed the data collection of all follow-up points.

You may not qualify if:

  • received radiotherapy or chemotherapy before surgery;
  • had other sites of malignant tumors;
  • complicated with severe heart, liver, lung and renal insufficiency;
  • had physical disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xueyi Miao

Nanjing, Jiangsu, 211166, China

Location

MeSH Terms

Conditions

Frailty

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2023

First Posted

March 31, 2023

Study Start

March 1, 2021

Primary Completion

October 1, 2021

Study Completion

February 1, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

CN(1)