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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03705546
Other study ID # SMC 2015-11-025-002(C)
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 4, 2016
Est. completion date March 3, 2026

Study information

Verified date May 2024
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine the impact of physical activity on the postoperative symptoms, complication, and quality of life.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1050
Est. completion date March 3, 2026
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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 The change of quality of life: (EORTC QLQ) core30 (C30) 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 Postoperative pulmonary complications Incidence of pulmonary complications including air leak, atelectasis, pleural effusion, pneumonia, etc. Within 30 days after surgery
Secondary The change of symptom 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
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