Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients

Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients: A Prospective Cohort Study

This prospective cohort study examines the impact of perioperative physical activity on postoperative pulmonary complications among esophageal cancer patients.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Neoplasms

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Young Mog Shim, MD; Phone Number: +82-2-3410-6491; Email: genehee.lee@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Jae Kyung Lee, MSc; Phone Number: +82-2-3410-6491; Email: jk1230.lee@sbri.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are diagnosed with eshophageal cancer and scheduled to receive curative esophagectomy at a single cancer hospital in Seoul, Korea

Description

Inclusion Criteria:

• Patients who are diagnosed with esophageal cancer and scheduled to receive curative esophagectomy
• Patients who are able to read and understand the questionnaire
• Patients who are able to communicate with research personnel
• Patients who recognize the purpose of this study and provide written informed consent
• Patients without treatment for psychiatric disease

Exclusion Criteria:

• Patients who have difficulty for walking
• Patients with history of other cancer in the last 3 years
• Patients with neoadjuvant chemotherapy and/or radiation therapy
• Patients with recurrent esophageal cancer
• Patients with multiple cancer
• Foreigner or overseas patients who were not able to regularly participate this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary complications	Incidence of pneumonia and atelectasis	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of quality of life	The change of quality of life is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core30 (C30). The quality of life scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of quality of life.	Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
The change of symptom	The change of symptoms is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) oesophageal cancer module (OES18). The symptom scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of symptom.	Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Young Mog Shim, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2015
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 2014-10-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No