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

Sponsor
Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04929587
Collaborator
(none)
406
1
13
31.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: This is a observational research, there is no intervention

Study Design

Study Type:
Observational
Actual Enrollment :
406 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Feb 2, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Province Hospital Nanjing China

Sponsors and Collaborators

  • Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lingyu Ding, Clinical nurse, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT04929587
Other Study ID Numbers:
  • LDing
First Posted:
Jun 18, 2021
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
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:

Study Results

No Results Posted as of Apr 13, 2022