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

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
Incidence of pulmonary complications including air leak, atelectasis, pleural effusion, pneumonia, etc.
Within 30 days after surgery
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.

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.

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

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.

Clinical Trials on Lung Neoplasms

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