Clinical trial NCT03705546: The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer
Official title: The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer Survivors: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Neoplasms
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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

Primary outcomes:
measure: The change of quality of life: (EORTC QLQ) core30 (C30)
timeFrame: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
Secondary outcomes:
measure: Postoperative pulmonary complications
timeFrame: Within 30 days after surgery
measure: The change of symptom
timeFrame: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hong Kwan Kim, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.