NCT03215537

Brief Summary

This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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 2, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
Last Updated

March 17, 2021

Status Verified

February 1, 2021

Enrollment Period

4.7 years

First QC Date

July 5, 2017

Last Update Submit

March 16, 2021

Conditions

Lung Cancer

Keywords

physical activitycardiopulmonary functionquality of lifePerioperative managementcomprehensive interventionhealth behavior model

Outcome Measures

Primary Outcomes (1)

  • Changes of cardiopulmonary function

    six minute walk test

    Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery

Secondary Outcomes (6)

  • complication

    1 month after surgery, 6 months after surgery, 1year after surgery

  • Changes of pulmonary function

    Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery

  • Changes of physical activity

    Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery

  • Changes of physical fitness

    Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery

  • Changes of quality of life

    Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery

  • +1 more secondary outcomes

Study Arms (2)

observation

NO INTERVENTION

No Intervention

comprehensive intervention

ACTIVE COMPARATOR

preoperative: exercise counseling postoperative : symptoms counseling and pulmonary rehabilitation

Behavioral: comprehensive intervention

Interventions

comprehensive interventionBEHAVIORAL

preoperative and postoperative exercise program

comprehensive intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lung cancer patients before surgery

You may not qualify if:

  • Eastern Cooperative Oncology Group Performance Status \<1
  • Neoadjuvant therapy
  • Multiple cancer
  • Recurrent lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Lee J, Kong S, Shin S, Lee G, Kim HK, Shim YM, Cho J, Kang D, Park HY. Wearable Device-Based Intervention for Promoting Patient Physical Activity After Lung Cancer Surgery: A Nonrandomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434180. doi: 10.1001/jamanetworkopen.2024.34180.

    PMID: 39302678DERIVED

MeSH Terms

Conditions

Lung NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Jae Ill Zo

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 12, 2017

Study Start

March 2, 2016

Primary Completion

November 16, 2020

Study Completion

December 2, 2023

Last Updated

March 17, 2021

Record last verified: 2021-02

Locations

KR(1)