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NCT Number: NCT04929587

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Frailty Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangsu Province Hospital

Nanjing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

This is a observational research, there is no intervention

Other

This is a observational research, there is no intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 18, 2021
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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