Frailty Trajectories and Their Association With Health Outcomes

• Sponsor: Nanjing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05793229
• Collaborator: (none)
• Enrollment: 381
• Location: 1
• Actual Duration (Months): 23.1
• Patients Per Site Per Month: 16.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Syndrome	Other: observation

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 381 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
improving frailty Class 1	Other: observation; observation
maintaining frailty Class 2	Other: observation; observation
deteriorating frailty Class 3	Other: observation; observation

Outcome Measures

Primary Outcome Measures

1. quality of life (QOL) [at 1-year after surgery]

   used EORTC QLQ-STO22 to assess.

2. disability [at 1-year after surgery]

   used Elderly Disability Assessment Scale to assess.

3. 1-year hospital readmissions [at 1-year after surgery]

   captured from medical records.

4. total costs [at 1-year after surgery]

   captured from medical records.

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;

• 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.

Contacts and Locations

Locations

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

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: NCT05793229
• Other Study ID Numbers: Nanjing Medical University
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Frailty

Study Results

No Results Posted as of Mar 31, 2023