Lifestyle Intervention for Prevention of Gastric Neoplasm
Positive Lifestyle Interventions for the Prevention of Gastric Pre-cancer and Cancer Occurrences in Patients With Chronic Atrophy Gastritis and Reccurence of Gastric Cancer After Endoscopic Resection
1 other identifier
interventional
350
1 country
1
Brief Summary
The purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2015
CompletedFirst Submitted
Initial submission to the registry
February 5, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 7, 2022
May 1, 2022
7.7 years
February 5, 2016
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
gastric caner occurrence
gastric cancer proved by gastroscopy biopsy
4 years
Secondary Outcomes (2)
All cause mortality
5 years
gastric tissue DNA methylation change of selected genes
4 years
Study Arms (2)
Lifestyle intervention
ACTIVE COMPARATORA better lifestyle that are supposed to prevent gastric cancer occurrence are advised to patients. Measures includes dietary change and cessation of smoking and alcohol abuse. Behavioural and cognitive strategies from investigators are performed to patients to ensure adherence to established intervention.
No intervention
NO INTERVENTIONNo meassures are taken to change life style of enrolled patients.
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of chronic atrophy gastritis proved by gastroscopy biopsy pathology or early gastric cancer patients who have recieved endoscopic resection
- have one or several bad lifestyle habits such as eating too much salt, eating too few fruits, smoking, drinking wine, and lack of sleep.
You may not qualify if:
- patients who refuse to change lifestyle according to the trial plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Linyi People's Hospital affiliated to Shandong University
Linyi, Shandong, 276000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lin Lu, MD
Shandong University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 5, 2016
First Posted
February 10, 2016
Study Start
March 12, 2015
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
November 7, 2022
Record last verified: 2022-05