Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory

April 5, 2022 updated by: Lingyu Ding, Nanjing Medical University
Frailty is common in patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the health ecology theory , to change some critical variable factors in the future, improving the overall prognosis of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

406

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanjing, China
        • Jiangsu Province Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients aged over 60 years old and who have gastric cancer with clear surgical indications

Description

Inclusion Criteria:

  • Clinical diagnosis of gastric cancer
  • Age over 60 years old
  • With clear surgical indication

Exclusion Criteria:

  • Malignant tumors in other parts of the body
  • Severe cardiopulmonary complications
  • Receive palliative surgery
  • Have received preoperative radiotherapy and chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty assessed by Frailty Phenotype (FP)
Time Frame: preoperative period
The total score is 0~5, and a score of 0~3 is considered as frailty.
preoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)
Time Frame: preoperative period
NRS2002 comprises 3 components: nutritional status, disease status and age, with a total score ranging from 0 to 7. A score of ≥3 is considered to be at nutritional risk.
preoperative period
Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)
Time Frame: preoperative period
HADS contains 2 subscales: anxiety and depression subscales. Each subscale consists of 7 items, with a total score ranging from 0 to 21. A score of each subacale reaches 8 or more is regarded as the presence of anxiety or depression.
preoperative period
Social support assessed by Social Support Rate Scale (SSRS)
Time Frame: preoperative period
SSRS contains 10 items and 3 dimensions, which are objective support, subjective support, and support utilization, with higher scores indicating higher degrees of the corresponding dimensions.
preoperative period
Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)
Time Frame: preoperative period
The total score ranges from 0 to 10, and a score of ≤6 is considered as having family dysfunction.
preoperative period
Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)
Time Frame: preoperative period
A total score range from 0 to 21, a score of 0~5 indicates "very good" sleep quality; a score of 6~10 indicates "good" sleep quality; a score of 11~15 indicates "poor" sleep quality; a score of 16~21 indicates "very poor" sleep quality.
preoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

February 2, 2022

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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