Lifestyle Intervention for Prevention of Gastric Neoplasm

NCT ID: NCT02679495

Last Updated: 2022-11-07

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-12

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lifestyle intervention

A 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.

Group Type ACTIVE_COMPARATOR

Active measures of lifestyle modification

Intervention Type BEHAVIORAL

No intervention

No meassures are taken to change life style of enrolled patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active measures of lifestyle modification

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* patients who refuse to change lifestyle according to the trial plan
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Lijun PENG, MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Lu, MD

Role: STUDY_CHAIR

Shandong University

Locations

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Linyi People's Hospital affiliated to Shandong University

Linyi, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2015WS0366

Identifier Type: -

Identifier Source: org_study_id

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