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An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial (Gastric cancer)

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
physical activity intervention
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring Gastric cancer, minimally invasive gastrectomy, Physical activity intervention

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Early gastric cancer patients
  2. Undergoing minimally invasive surgery
  3. AGE: 20-70
  4. ECOG: 0-1
  5. A patient who did not exercise regularly for the last 6 months
  6. A patient who signed the informed consent

Exclusion Criteria:

  1. Pregnancy or plans to become pregnant
  2. Cognitive disabilities
  3. Other primary cancer history
  4. History of major abdominal surgery except current surgery
  5. Cardiopulmonary medical comorbidity
  6. Living > 60 km from the hospital

Sites / Locations

  • Yonsei University College of Medicine, Seodaemun-gu, Shinchondong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

physical activity intervention

Outcomes

Primary Outcome Measures

QoL(quality of life)

Secondary Outcome Measures

cardiopulmonary function test
vital signs reflecting of inflammation level
nutrition condition

Full Information

First Posted
March 31, 2014
Last Updated
January 17, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02120885
Brief Title
An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial
Acronym
Gastric cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 14, 2014 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Gastric cancer is a major health issue and one of the most common malignance in Korea. With the popularization of cancer screenings and increasing the average lifespan, the number of gastric cancer patients is increased. In the past, most of the research were concerned with survival and recovery after cancer surgery. However, as the medical technology had been developed and recovery rate and survival rate of cancer patients had risen, the patients wanted to return to a daily life and desire for participation for leisure. In other words, the patients who underwent surgery wants to maintain a high quality of life(QOL) level as like prior to cancer surgery.
Detailed Description
There are many reports on the effect of the exercise program after cancer surgery. In addition, exercise program was associated with improving the QOL and functional recovery, decreasing a mood of depression, maintaining a muscle mass and improving the survival rate. However, the subject patients of previous studies were Western people. Therefore, The results were not disclosed whether the exercise program suited to the body characteristics of Korean people. Furthermore there was no exercise program studies for the gastric cancer patients. Medical service for cancer patients care should include not only diagnosis, treatment as like surgery but efforts on enhancing the quality of life. In other words, post-management education and management program as like exercise program are necessary for the cancer patients after surgery. Thus, the investigators have done the pilot study about how to practice the exercise program and how to evaluate the effect on the recovery. Based on the result of pilot study which could identify the safety and the feasibility , the investigators would like to do a prospective randomized controlled study to prove the effect of exercise program after surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, minimally invasive gastrectomy, Physical activity intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
physical activity intervention
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
physical activity intervention
Intervention Description
Exercise program is scheduled to be conducted in three phases. Phase I is in-hospital exercise program. This program will be conducted in hospital during 1 week after surgery. Phase II is home-exercise program that will be performed at home during 1 week after discharge. Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program. Main-exercise program is focused on the functional recovery.
Primary Outcome Measure Information:
Title
QoL(quality of life)
Time Frame
10 weeks after gastrectomy
Secondary Outcome Measure Information:
Title
cardiopulmonary function test
Time Frame
10 weeks after gastrectomy
Title
vital signs reflecting of inflammation level
Time Frame
10 weeks after gastrectomy
Title
nutrition condition
Time Frame
10 weeks after gastrectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Early gastric cancer patients Undergoing minimally invasive surgery AGE: 20-70 ECOG: 0-1 A patient who did not exercise regularly for the last 6 months A patient who signed the informed consent Exclusion Criteria: Pregnancy or plans to become pregnant Cognitive disabilities Other primary cancer history History of major abdominal surgery except current surgery Cardiopulmonary medical comorbidity Living > 60 km from the hospital
Facility Information:
Facility Name
Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
City
Seoul
ZIP/Postal Code
134
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial

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