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

Lung Neoplasms Clinical Trial

Official title:

The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer Survivors: A Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03705546
• Other study ID #: SMC 2015-11-025-002(C)
• Status: Active, not recruiting
• Start date: March 4, 2016
• Est. completion date: March 3, 2026

Study information

• Verified date: December 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Lung Neoplasms

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