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NCT03231462 Clinical Trial

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

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03231462
Other study ID # 2014-10-035
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 6, 2015
Est. completion date December 31, 2024

Study information
Verified date September 2018
Source Samsung Medical Center
Contact Young Mog Shim, MD
Phone +82-2-3410-6491
Email genehee.lee@samsung.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 31, 2024
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pulmonary complications Incidence of pneumonia and atelectasis Within 30 days after surgery
Secondary 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
Secondary 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
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