NCT04929587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

June 9, 2021

Last Update Submit

April 5, 2022

Conditions

Gastric CancerFrailty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)

    preoperative period

  • Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)

    preoperative period

  • Social support assessed by Social Support Rate Scale (SSRS)

    preoperative period

  • Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)

    preoperative period

  • Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)

    preoperative period

Interventions

This is a observational research, there is no interventionOTHER

This is a observational research, there is no intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Province Hospital

Nanjing, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsFrailty

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical nurse

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 18, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

February 2, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

CN(1)