Temporal Transformation Mechanism and Intervention Strategies of Frail-related Dietary Behaviors in Older Gastric Cancer Survivors

NCT ID: NCT07176455

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

438 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer (GC) Frailty in Adult Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Frail-promoting dietary behavior group

Anti-frailty dietary behavior intervention

Intervention Type BEHAVIORAL

Design intervention measures based on the mechanism of dietary behavior changes related to frailty

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anti-frailty dietary behavior intervention

Design intervention measures based on the mechanism of dietary behavior changes related to frailty

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Severe cardiac, hepatic, pulmonary, or renal insufficiency; Tumors in other sites.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yinning Guo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nanjing Medical University

Nanjing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-79

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.