Frailty Trajectories and Their Association With Health Outcomes

Frailty Syndrome Clinical Trial

Official title:

Exploration of Frailty Trajectories and Their Association With Health Outcomes in Elderly Gastric Cancer Survivors Undergoing Radical Gastrectomy: a Prospective Longitudinal Observation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05793229
• Other study ID #: Nanjing Medical University
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Our study suggested the significant heterogeneity in frailty trajectories among elderly gastric cancer survivors, and that different trajectories had different effects on health outcomes. Our results infer the necessity for prevention strategies in elderly gastric cancer survivors to manage heterogeneous frailty trajectories.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: February 1, 2023
• Est. primary completion date: October 1, 2021
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• received radiotherapy or chemotherapy before surgery;

• had other sites of malignant tumors;

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

• had physical disability.

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Intervention

Other:
• observation
observation

Locations

Country	Name	City	State
China	Xueyi Miao	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life (QOL)	used EORTC QLQ-STO22 to assess.	at 1-year after surgery
Primary	disability	used Elderly Disability Assessment Scale to assess.	at 1-year after surgery
Primary	1-year hospital readmissions	captured from medical records.	at 1-year after surgery
Primary	total costs	captured from medical records.	at 1-year after surgery