ResilienceNCT06033716
Development and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors
An observational study of Resilience and Anxiety, run by Nanjing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Resilience, Anxiety, Depression
- What is being tested?
- Measurement correlation variable
- How many people
- 412 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: select elderly gastric cancer patients who had undergone cancer surgery and were receiving medical treatment at a tertiary hospital
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Resilience, Anxiety, Depression
- Being tested
- Measurement correlation variable
- Keywords
- gastric cancer, resilience, anxiety, depression, trajectory
- Medical subject headings
- Anxiety Disorders, Depression, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement correlation variableOther
resilience and anxiety and depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Mar 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinning Guo, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033716
- Sponsor's protocol ID
- 2020-273-1
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06033716
- Acronym / sponsor ID
- 2020-273-1
- Conditions
- Resilience, Anxiety, Depression
- Keywords
- gastric cancer, resilience, anxiety, depression, trajectory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- select elderly gastric cancer patients who had undergone cancer surgery and were receiving medical treatment at a tertiary hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement correlation variableresilience and anxiety and depression | Other | – |
Primary outcome
resilience
Time frame: 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.
anxiety
Time frame: 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.
depression
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resilience and Anxiety, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resilience (time frame: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.