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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06033716
Other study ID # 2020-273-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date October 31, 2022

Study information

Verified date September 2023
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 412
Est. completion date October 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Measurement correlation variable
resilience and anxiety and depression

Locations

Country Name City State
China Yinning Guo Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 a 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)
Primary 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 a 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)
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