Gastric Cancer (GC)NCT07176455
Temporal Transformation Mechanism and Intervention Strategies of Frail-related Dietary Behaviors in Older Gastric Cancer Survivors
An observational study of Gastric Cancer (GC) and Frailty in Adult Surgery, run by Nanjing Medical University at 1 site in China.
Trial summary
The investigators invite participants to participate in the research project "Research on the Maintenance Mechanism and Intervention Strategies of Dietary Behavior Changes Related to Frailty in Elderly Gastric Cancer Survivors". Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastric Cancer (GC), Frailty in Adult Surgery
- What is being tested?
- Anti-frailty dietary behavior intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Jun 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing radical gastrectomy for gastric cancer at selected tertiary hospitals in Jiangsu Province between July 2025 and October 2026 were enrolled as study subjects. Discharge served as the baseline (T0), with follow-up surveys conducted at 1 month post-surgery (T1), 3 months post-surgery (T2), and 6 months post-surgery (T3).
Who may be able to join
- Clinical diagnosis of gastric cancer; Performed the radical gastrectomy; Discharge within one month after surgery; Age ≥60 years old; Aware of personal diagnosis; Must be able to articulate views clearly; Voluntarily agree to participate in this study and sign the informed consent form.
Who cannot join
- Severe cardiac, hepatic, pulmonary, or renal insufficiency; Tumors in other sites.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Research on the Temporal Transformation Mechanism and Intervention Strategies of Frail-related Dietary Behaviors in Older Gastric Cancer Survivors
The investigators invite participants to participate in the research project "Research on the Maintenance Mechanism and Intervention Strategies of Dietary Behavior Changes Related to Frailty in Elderly Gastric Cancer Survivors". This project is funded by the School of Nursing of Nanjing Medical University and will be carried out in the Gastroenterology Department of the General Surgery Department of the First Affiliated Hospital of Nanjing Medical University and the Affiliated Cancer Hospital of Nanjing Medical University. Participants have been invited to join this research because participants meet the inclusion criteria for the study.
This informed consent form provides participants with some information to help participants decide whether to participate in this clinical study. Participants' participation in this study is voluntary. This research has been reviewed and approved by the Ethics Committee of Nanjing Medical University. If participants agree to join this study, please refer to the following instructions. Please read carefully. If participants have any questions, please raise them to the researcher in charge of this study.
Read more
Research objective (Why conduct this research?) China is a country with a high incidence of gastric cancer. Its incidence and mortality rates both rank among the top five in the world, seriously endangering the health of its citizens. With the intensification of aging, the proportion of gastric cancer patients over 60 years old among all gastric cancer patients has reached as high as 75.2%, making elderly gastric cancer patients a large group. Nutrition plays a crucial role in the frailty development of elderly survivors of gastric cancer.
Research process and methods (What needs to be done if participating in the research?) If participants are willing to participate in this study, participants will be surveyed at the time points of discharge and 1 month, 3 months and 6 months after the operation. During participants' hospitalization (at admission and discharge), the investigators will use the Sociodemographic and Physiological Pathological Questionnaire, the Dietary Behavior Scale, the Tilburg Frailty Scale, the Depression-Anxiety-Stress Scale, the Family Nutrition Behavior Health Action Process Scale for Postoperative Gastric Cancer Patients, the Family Care Index Evaluation Scale, the Perceived Social Support Scale, the Family Food Environment Scale, and the Policy Environment Questionnaire to investigate participants Relevant variable indicators; At 1 month, 3 months and 6 months after the operation, telephone follow-up will be conducted using the Eating Behavior Scale, Tilburg Frailty Scale, Depression-anxiety-Stress Scale, Family Nutrition Behavior Health Action Process Scale for Postoperative Gastric Cancer Patients, Family Care Index Rating Scale, Perceived Social Support Scale and Family Food Environment Scale to dynamically evaluate the scores of relevant variables. It is used for the extraction of dietary behaviors related to later frailty and the exploration of the maintenance mechanism of transformation.
What are the possible benefits of participating in the research? During the longitudinal telephone follow-up, the investigators can answer some of your questions and provide health assistance to participants. Meanwhile, the research results of this study are beneficial for later dietary nutrition and frailty management.
What are the possible risks of participating in the research? The above-mentioned survey poses no risk to participants' health or prognosis recovery.
Do participants need to pay any relevant fees to participate in the research? There is no need to pay any related fees to participate in this study.
Is personal privacy kept confidential? The data in this study may be published, but participants' personal privacy-related information will be strictly confidential.
Must participants take part in the research? Participation in this research is completely voluntary. Participants can refuse to take part in the research or withdraw from it at any stage of the research process. The investigators sincerely hope that participants will contribute to scientific research. However, whether participants participate or not, the investigators will respect participants' choice and guarantee that it will not have any impact on participants' diagnosis, treatment and care. If participants decide to participate in this study, please sign this informed consent form.
If participants have any questions related to participants' personal rights and interests, participants can contact the Ethics Committee of Nanjing Medical University. The contact number is 025-86869212.
- Conditions
- Gastric Cancer (GC), Frailty in Adult Surgery
- Being tested
- Anti-frailty dietary behavior intervention
- Keywords
- gastric cancer, frailty, dietary behavior
- 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.
Anti-frailty dietary behavior interventionBehavioural
Design intervention measures based on the mechanism of dietary behavior changes related to frailty
| Study group | Role | What they receive |
|---|---|---|
| Frail-promoting dietary behavior group | Not described Receives: Behavioral: Anti-frailty dietary behavior intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
frailty:frailty was measured using the Tilburg frailty indicator (TFI). It consists of 15 items across three domains, scores range from 0 to 15, with higher scores indicating greater frailty; a score ≥5 denotes frailty.
Measured: The first month, the third month and the sixth month after radical gastrectomy for gastric cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jul 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 438 participants (estimated)
- Target duration
- 1 Month
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
- NCT07176455
- Sponsor's protocol ID
- 2025-79
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was applied for by all of us together. Everyone is clear about the research plan, so there is no need to share the IPD again
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Temporal Transformation Mechanism and Intervention Strategies of Frail-related Dietary Behaviors in Older Gastric Cancer Survivors
- ClinicalTrials.gov ID
- NCT07176455
- Acronym / sponsor ID
- 2025-79
- Conditions
- Gastric Cancer (GC), Frailty in Adult Surgery
- Keywords
- gastric cancer, frailty, dietary behavior
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
The investigators invite participants to participate in the research project "Research on the Maintenance Mechanism and Intervention Strategies of Dietary Behavior Changes Related to Frailty in Elderly Gastric Cancer Survivors". This project is funded by the School of Nursing of Nanjing Medical University and will be carried out in the Gastroenterology Department of the General Surgery Department of the First Affiliated Hospital of Nanjing Medical University and the Affiliated Cancer Hospital of Nanjing Medical University. Participants have been invited to join this research because participants meet the inclusion criteria for the study.
This informed consent form provides participants with some information to help participants decide whether to participate in this clinical study. Participants' participation in this study is voluntary. This research has been reviewed and approved by the Ethics Committee of Nanjing Medical University. If participants agree to join this study, please refer to the following instructions. Please read carefully. If participants have any questions, please raise them to the researcher in charge of this study.
Research objective (Why conduct this research?) China is a country with a high incidence of gastric cancer. Its incidence and mortality rates both rank among the top five in the world, seriously endangering the health of its citizens. With the intensification of aging, the proportion of gastric cancer patients over 60 years old among all gastric cancer patients has reached as high as 75.2%, making elderly gastric cancer patients a large group. Nutrition plays a crucial role in the frailty development of elderly survivors of gastric cancer.
Research process and methods (What needs to be done if participating in the research?) If participants are willing to participate in this study, participants will be surveyed at the time points of discharge and 1 month, 3 months and 6 months after the operation. During participants' hospitalization (at admission and discharge), the investigators will use the Sociodemographic and Physiological Pathological Questionnaire, the Dietary Behavior Scale, the Tilburg Frailty Scale, the Depression-Anxiety-Stress Scale, the Family Nutrition Behavior Health Action Process Scale for Postoperative Gastric Cancer Patients, the Family Care Index Evaluation Scale, the Perceived Social Support Scale, the Family Food Environment Scale, and the Policy Environment Questionnaire to investigate participants Relevant variable indicators; At 1 month, 3 months and 6 months after the operation, telephone follow-up will be conducted using the Eating Behavior Scale, Tilburg Frailty Scale, Depression-anxiety-Stress Scale, Family Nutrition Behavior Health Action Process Scale for Postoperative Gastric Cancer Patients, Family Care Index Rating Scale, Perceived Social Support Scale and Family Food Environment Scale to dynamically evaluate the scores of relevant variables. It is used for the extraction of dietary behaviors related to later frailty and the exploration of the maintenance mechanism of transformation.
What are the possible benefits of participating in the research? During the longitudinal telephone follow-up, the investigators can answer some of your questions and provide health assistance to participants. Meanwhile, the research results of this study are beneficial for later dietary nutrition and frailty management.
What are the possible risks of participating in the research? The above-mentioned survey poses no risk to participants' health or prognosis recovery.
Do participants need to pay any relevant fees to participate in the research? There is no need to pay any related fees to participate in this study.
Is personal privacy kept confidential? The data in this study may be published, but participants' personal privacy-related information will be strictly confidential.
Must participants take part in the research? Participation in this research is completely voluntary. Participants can refuse to take part in the research or withdraw from it at any stage of the research process. The investigators sincerely hope that participants will contribute to scientific research. However, whether participants participate or not, the investigators will respect participants' choice and guarantee that it will not have any impact on participants' diagnosis, treatment and care. If participants decide to participate in this study, please sign this informed consent form.
If participants have any questions related to participants' personal rights and interests, participants can contact the Ethics Committee of Nanjing Medical University. The contact number is 025-86869212.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail-promoting dietary behavior group | – | Behavioral: Anti-frailty dietary behavior intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radical gastrectomy for gastric cancer at selected tertiary hospitals in Jiangsu Province between July 2025 and October 2026 were enrolled as study subjects. Discharge served as the baseline (T0), with follow-up surveys conducted at 1 month post-surgery (T1), 3 months post-surgery (T2), and 6 months post-surgery (T3).
Key inclusion criteria (1 listed)
- Clinical diagnosis of gastric cancer; Performed the radical gastrectomy; Discharge within one month after surgery; Age ≥60 years old; Aware of personal diagnosis; Must be able to articulate views clearly; Voluntarily agree to participate in this study and sign the informed consent form.
Key exclusion criteria (1 listed)
- Severe cardiac, hepatic, pulmonary, or renal insufficiency; Tumors in other sites.
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 |
|---|---|---|
| Anti-frailty dietary behavior interventionDesign intervention measures based on the mechanism of dietary behavior changes related to frailty | Behavioural | Frail-promoting dietary behavior group |
Primary outcome
frailty:frailty was measured using the Tilburg frailty indicator (TFI). It consists of 15 items across three domains, scores range from 0 to 15, with higher scores indicating greater frailty; a score ≥5 denotes frailty.
Time frame: The first month, the third month and the sixth month after radical gastrectomy for gastric cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. This was applied for by all of us together. Everyone is clear about the research plan, so there is no need to share the IPD again
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TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
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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.
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 (GC) and Frailty in Adult Surgery, 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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:frailty was measured using the Tilburg frailty indicator (TFI). It consists of 15 items across three domains, scores range from 0 to 15, with higher scores indicating greater frailty; a score ≥5 denotes frailty. (time frame: The first month, the third month and the sixth month after radical gastrectomy for gastric cancer). 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 22 Sep 2025.