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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929587
• Other study ID #: LDing
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: February 2, 2022

Study information

• Verified date: April 2022
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: February 2, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• This is a observational research, there is no intervention
This is a observational research, there is no intervention

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty assessed by Frailty Phenotype (FP)	The total score is 0~5, and a score of 0~3 is considered as frailty.	preoperative period
Secondary	Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)	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
Secondary	Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)	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
Secondary	Social support assessed by Social Support Rate Scale (SSRS)	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
Secondary	Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)	The total score ranges from 0 to 10, and a score of =6 is considered as having family dysfunction.	preoperative period
Secondary	Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)	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