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

Completed

• Conditions: Gastric Cancer; Frailty

• Registration Number: NCT04929587
• Lead Sponsor: Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-18
• Primary Completion: 2021-06-30
• Study Completion: 2022-02-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frailty assessed by Frailty Phenotype (FP)	preoperative period	The total score is 0\~5, and a score of 0\~3 is considered as frailty.

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)	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.
Social support assessed by Social Support Rate Scale (SSRS)	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.
Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)	preoperative period	The total score ranges from 0 to 10, and a score of ≤6 is considered as having family dysfunction.
Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)	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.
Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)	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.

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, China