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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
Started Mar 2014
Shorter than P25 for phase_3 gastric-cancer
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 14, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2017
CompletedJanuary 22, 2019
January 1, 2019
3.3 years
March 31, 2014
January 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
QoL(quality of life)
10 weeks after gastrectomy
Secondary Outcomes (3)
cardiopulmonary function test
10 weeks after gastrectomy
vital signs reflecting of inflammation level
10 weeks after gastrectomy
nutrition condition
10 weeks after gastrectomy
Study Arms (2)
Exercise group
EXPERIMENTALphysical activity intervention
Control group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
Seoul, 134, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 23, 2014
Study Start
March 14, 2014
Primary Completion
July 10, 2017
Study Completion
July 10, 2017
Last Updated
January 22, 2019
Record last verified: 2019-01