- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705546
The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer
May 22, 2024 updated by: Samsung Medical Center
The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer Survivors: A Prospective Cohort Study
The purpose of this study is to examine the impact of physical activity on the postoperative symptoms, complication, and quality of life.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Observational
Enrollment (Actual)
1050
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pulmonary complications
Time Frame: Within 30 days after surgery
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Incidence of pulmonary complications including air leak, atelectasis, pleural effusion, pneumonia, etc.
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Within 30 days after surgery
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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.
|
Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hong Kwan Kim, Ph.D., Samsung Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Shin S, Kong S, Kang D, Lee G, Cho JH, Shim YM, Cho J, Kim HK, Park HY. Longitudinal changes in pulmonary function and patient-reported outcomes after lung cancer surgery. Respir Res. 2022 Aug 30;23(1):224. doi: 10.1186/s12931-022-02149-9.
- Lee H, Kim HK, Kang D, Kong S, Lee JK, Lee G, Shin S, Cho J, Zo JI, Shim YM, Park HY. Prognostic Value of 6-Min Walk Test to Predict Postoperative Cardiopulmonary Complications in Patients With Non-small Cell Lung Cancer. Chest. 2020 Jun;157(6):1665-1673. doi: 10.1016/j.chest.2019.12.039. Epub 2020 Jan 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2016
Primary Completion (Actual)
December 31, 2020
Study Completion (Estimated)
March 3, 2026
Study Registration Dates
First Submitted
October 5, 2018
First Submitted That Met QC Criteria
October 12, 2018
First Posted (Actual)
October 15, 2018
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 22, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC 2015-11-025-002(C)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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