Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705546
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to examine the impact of physical activity on the postoperative symptoms, complication, and quality of life.

Condition or disease
Lung Neoplasms

Detailed Description:
Non-small cell lung cancer (NSCLC) survivor is increasing as developing early diagnosis and perioperative management. Despite multidisciplinary treatment, Surgery is the primary treatment option for cure in NSCLC. The patients with lung cancer who underwent surgery have limitation of pulmonary function and high risk of co-morbidities. Perioperative physical activity has been shown to reduce symptoms and prevent complications, improve long term quality of life after surgery. But validated exercise regimen has not been established for lung cancer patients. Therefore, Evidence-based guideline focusing on lung cancer after surgery is needed.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1050 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer Survivors: A Prospective Cohort Study
Actual Study Start Date : March 4, 2016
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 3, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Postoperative pulmonary complications [ Time Frame: Within 30 days after surgery ]
    Incidence of pulmonary complications including air leak, atelectasis, pleural effusion, pneumonia, etc.

  2. The change of symptom [ Time Frame: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery ]
    The change of symptom is measured using the European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) lung cancer module 13 (LC13). The scale for symptom is transformed into a score from 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of symptom.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population in this study consists of patients who are diagnosed with lung cancer and scheduled for surgery in a lung cancer center at Seoul.
Criteria

Inclusion Criteria:

  • Patients who are diagnosed with lung cancer
  • Patients who are able to walk with ECOG (Eastern Cooperative Oncology Group) performance status < 1
  • Patients who understand the purpose of this study and provide the written informed consent

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 who are diagnosed with recurrent lung cancer or multiple cancer
  • Foreigner of patients from overseas who are not able regularly participate in this study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705546


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Study Director: Jae Ill Zo, Ph.D. Samsung Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03705546    
Other Study ID Numbers: SMC 2015-11-025-002(C)
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases