NCT03705546

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

October 5, 2018

Last Update Submit

May 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Postoperative pulmonary complications

    Within 30 days after surgery

  • The change of symptom

    Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (3)

  • Kong S, Shin S, Jeon YJ, Lee G, Cho JH, Kim HK, Shim YM, Cho J, Kang D, Park HY. Factors associated with failure of cardiopulmonary function recovery after lung cancer surgery. Respirology. 2023 Nov;28(11):1060-1068. doi: 10.1111/resp.14581. Epub 2023 Aug 29.

  • 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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hong Kwan Kim, Ph.D.

    Samsung Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 15, 2018

Study Start

March 4, 2016

Primary Completion

December 31, 2020

Study Completion

March 3, 2026

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations