Development and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors

Sponsor
Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT06033716
Collaborator
(none)
412
1
20
20.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measurement correlation variable

Study Design

Study Type:
Observational
Actual Enrollment :
412 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Exploring the Developmental Changes and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors: Based on Latent Growth Modeling and Cross-lagged Modeling
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Oct 31, 2022
Actual Study Completion Date :
Oct 31, 2022

Outcome Measures

Primary Outcome Measures

  1. resilience [immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)]

    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.

  2. anxiety [immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)]

    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.

  3. depression [immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yinning Guo Nanjing Jiangsu China

Sponsors and Collaborators

  • Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yinning Guo, Principal Investigator, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT06033716
Other Study ID Numbers:
  • 2020-273-1
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yinning Guo, Principal Investigator, Nanjing Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023