NCT06033716

Brief Summary

This study will explore the dynamic interaction between mental resilience, anxiety and depression in elderly patients with gastric cancer 1 year after surgery, in order to better understand the role of these two factors in patients' mental health, and provide accurate insights for clinical practice and targeted psychological support strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

August 26, 2023

Last Update Submit

September 9, 2023

Conditions

ResilienceAnxietyDepression

Keywords

gastric cancerresilienceanxietydepressiontrajectory

Outcome Measures

Primary Outcomes (3)

  • resilience

    The Chinese version of 10-item Connor-Davidson Resilience Scale (CD-RISC-10), translated and revised by Chinese scholars, was used in this study. Cronbach's alpha for the Chinese version was 0.855, indicating good internal consistency. It was also applied to cancer patients in China. Each of which was scored on a 5-point Likert scale, ranging from 1 to 5 points, from "Never" to "Almost always", with higher scores representing a higher level of psychological resilience.

    immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)

  • anxiety

    Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.

    immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)

  • depression

    Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.

    immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)

Interventions

Measurement correlation variableOTHER

resilience and anxiety and depression

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

select elderly gastric cancer patients who had undergone cancer surgery and were receiving medical treatment at a tertiary hospital

You may qualify if:

  • diagnosed with gastric cancer by endoscopy or pathology
  • age ≥60 years old
  • radical gastrectomy was proposed
  • be able to communicate simply in writing and verbal

You may not qualify if:

  • received preoperative radiotherapy or chemotherapy;
  • combined with other sites of malignant tumors;
  • combined with severe heart, liver, lung and renal insufficiency;
  • recent using hormones, immunosuppressants;
  • with physical disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yinning Guo

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionStomach Neoplasms

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 13, 2023

Study Start

March 1, 2021

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

CN(1)