Frailty SyndromeNCT05793229
Frailty Trajectories and Their Association With Health Outcomes
An observational study of Frailty Syndrome, run by Nanjing Medical University at 1 site in China.
Trial summary
Frailty is common in gastric cancer survivors and seriously affects their prognosis. Multiple longitudinal follow-up assessment of frailty could provide a better understanding of the frailty change of individuals. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- observation
- How many people
- 381 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Feb 2023
- 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: Elderly patients with gastric cancer who attended a tertiary care hospital in China from March 2021 to October 2021 were selected for the study.
Who may be able to join
- diagnosed with gastric cancer by endoscopy or pathology;
- received radical gastrectomy the first time;
- aged ≥60 years;
- been able to communicate simply in writing and verbal;
- completed the data collection of all follow-up points.
Who cannot join
- received radiotherapy or chemotherapy before surgery;
- had other sites of malignant tumors;
- complicated with severe heart, liver, lung and renal insufficiency;
- had physical disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Frailty Trajectories and Their Association With Health Outcomes in Elderly Gastric Cancer Survivors Undergoing Radical Gastrectomy: a Prospective Longitudinal Observation Study
Frailty is common in gastric cancer survivors and seriously affects their prognosis. Multiple longitudinal follow-up assessment of frailty could provide a better understanding of the frailty change of individuals. Our aims were to identify the longitudinal trajectories of frailty and estimate their association with health outcomes in elderly gastric cancer survivors.
Read the detailed description
Our study suggested the significant heterogeneity in frailty trajectories among elderly gastric cancer survivors, and that different trajectories had different effects on health outcomes. Our results infer the necessity for prevention strategies in elderly gastric cancer survivors to manage heterogeneous frailty trajectories.
- Conditions
- Frailty Syndrome
- Being tested
- observation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
| Study group | Role | What they receive |
|---|---|---|
| improving frailty | Class 1 Receives: Other: observation | |
| maintaining frailty | Class 2 Receives: Other: observation | |
| deteriorating frailty | Class 3 Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life (QOL)
used EORTC QLQ-STO22 to assess.
Measured: at 1-year after surgery
disability
used Elderly Disability Assessment Scale to assess.
Measured: at 1-year after surgery
1-year hospital readmissions
captured from medical records.
Measured: at 1-year after surgery
total costs
captured from medical records.
Measured: at 1-year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueyi Miao, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793229
- Sponsor's protocol ID
- Nanjing Medical University
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Frailty Trajectories and Their Association With Health Outcomes in Elderly Gastric Cancer Survivors Undergoing Radical Gastrectomy: a Prospective Longitudinal Observation Study
- ClinicalTrials.gov ID
- NCT05793229
- Acronym / sponsor ID
- Nanjing Medical University
- Conditions
- Frailty Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 31 Mar 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.
Frailty is common in gastric cancer survivors and seriously affects their prognosis. Multiple longitudinal follow-up assessment of frailty could provide a better understanding of the frailty change of individuals. Our aims were to identify the longitudinal trajectories of frailty and estimate their association with health outcomes in elderly gastric cancer survivors.
Detailed description
Our study suggested the significant heterogeneity in frailty trajectories among elderly gastric cancer survivors, and that different trajectories had different effects on health outcomes. Our results infer the necessity for prevention strategies in elderly gastric cancer survivors to manage heterogeneous frailty trajectories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| improving frailty | – | Other: observationClass 1 |
| maintaining frailty | – | Other: observationClass 2 |
| deteriorating frailty | – | Other: observationClass 3 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Elderly patients with gastric cancer who attended a tertiary care hospital in China from March 2021 to October 2021 were selected for the study.
Key inclusion criteria (5 listed)
- diagnosed with gastric cancer by endoscopy or pathology;
- received radical gastrectomy the first time;
- aged ≥60 years;
- been able to communicate simply in writing and verbal;
- completed the data collection of all follow-up points.
Key exclusion criteria (4 listed)
- received radiotherapy or chemotherapy before surgery;
- had other sites of malignant tumors;
- complicated with severe heart, liver, lung and renal insufficiency;
- had physical disability.
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 |
|---|---|---|
| observationobservation | Other | deteriorating frailty, improving frailty, maintaining frailty |
Primary outcome
quality of life (QOL)
Time frame: at 1-year after surgery
used EORTC QLQ-STO22 to assess.
disability
Time frame: at 1-year after surgery
used Elderly Disability Assessment Scale to assess.
1-year hospital readmissions
Time frame: at 1-year after surgery
captured from medical records.
total costs
Time frame: at 1-year after surgery
captured from medical records.
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 31 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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 Frailty Syndrome, 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 5 inclusion and 4 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 31 Mar 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?
quality of life (QOL) (time frame: at 1-year after surgery). The study lists 4 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 31 Mar 2023.