Gastric CancerNCT04929587
Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory
An observational study of Gastric Cancer and Frailty, run by Nanjing Medical University at 1 site in China.
Trial summary
Frailty is common in patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastric Cancer, Frailty
- How many people
- 406 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 2 Feb 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
- No healthy volunteers
- Adult, Older adult
Study population: patients aged over 60 years old and who have gastric cancer with clear surgical indications
Who may be able to join
- Clinical diagnosis of gastric cancer
- Age over 60 years old
- With clear surgical indication
Who cannot join
- Malignant tumors in other parts of the body
- Severe cardiopulmonary complications
- Receive palliative surgery
- Have received preoperative radiotherapy and chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Frailty is common in patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the health ecology theory , to change some critical variable factors in the future, improving the overall prognosis of patients.
- Conditions
- Gastric Cancer, Frailty
- Being tested
- This is a observational research, there is no intervention
- Medical subject headings
- Stomach Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a observational research, there is no interventionOther
This is a observational research, there is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty assessed by Frailty Phenotype (FP)
The total score is 0~5, and a score of 0~3 is considered as frailty.
Measured: preoperative period
Secondary outcomes (5)
Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)
NRS2002 comprises 3 components: nutritional status, disease status and age, with a total score ranging from 0 to 7. A score of ≥3 is considered to be at nutritional risk.
Measured: preoperative period
Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)
HADS contains 2 subscales: anxiety and depression subscales. Each subscale consists of 7 items, with a total score ranging from 0 to 21. A score of each subacale reaches 8 or more is regarded as the presence of anxiety or depression.
Measured: preoperative period
Social support assessed by Social Support Rate Scale (SSRS)
SSRS contains 10 items and 3 dimensions, which are objective support, subjective support, and support utilization, with higher scores indicating higher degrees of the corresponding dimensions.
Measured: preoperative period
Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)
The total score ranges from 0 to 10, and a score of ≤6 is considered as having family dysfunction.
Measured: preoperative period
Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)
A total score range from 0 to 21, a score of 0~5 indicates "very good" sleep quality; a score of 6~10 indicates "good" sleep quality; a score of 11~15 indicates "poor" sleep quality; a score of 16~21 indicates "very poor" sleep quality.
Measured: preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyu Ding, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929587
- Sponsor's protocol ID
- LDing
- Status last verified
- Apr 2022
- First submitted
- 9 Jun 2021
- Last updated
- 13 Apr 2022
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory
- ClinicalTrials.gov ID
- NCT04929587
- Acronym / sponsor ID
- LDing
- Conditions
- Gastric Cancer, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 18 Jun 2021 (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 patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the health ecology theory , to change some critical variable factors in the future, improving the overall prognosis of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged over 60 years old and who have gastric cancer with clear surgical indications
Key inclusion criteria (3 listed)
- Clinical diagnosis of gastric cancer
- Age over 60 years old
- With clear surgical indication
Key exclusion criteria (4 listed)
- Malignant tumors in other parts of the body
- Severe cardiopulmonary complications
- Receive palliative surgery
- Have received preoperative radiotherapy and chemotherapy
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 |
|---|---|---|
| This is a observational research, there is no interventionThis is a observational research, there is no intervention | Other | – |
Primary outcome
Frailty assessed by Frailty Phenotype (FP)
Time frame: preoperative period
The total score is 0~5, and a score of 0~3 is considered as frailty.
5 secondary outcomes
Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)
Time frame: preoperative period
Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)
Time frame: preoperative period
Social support assessed by Social Support Rate Scale (SSRS)
Time frame: preoperative period
Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)
Time frame: preoperative period
Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: preoperative period
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 Apr 2022.
- 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 Gastric Cancer and Frailty, 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 3 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 13 Apr 2022. 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?
Frailty assessed by Frailty Phenotype (FP) (time frame: preoperative period). 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 Apr 2022.