Development of Patient Tailored Guideline of Physical Activity for Lung Cancer

Development of Patient Tailored Guideline of Physical Activity for Lung Cancer Survivor After Surgery; to Improve the Symptoms, Complications and Quality of Life

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: comprehensive intervention

Detailed Description

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:

1. understanding multi-dimensional factors affecting cardiopulmonary function and quality of life
2. development of multidisciplinary comprehensive intervention
3. evaluation the effects of comprehensive intervention using cluster design

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• lung cancer patients before surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: observation; No Intervention
Active Comparator: comprehensive intervention; preoperative: exercise counseling postoperative : symptoms counseling and pulmonary rehabilitation	Behavioral: comprehensive intervention; preoperative and postoperative exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of cardiopulmonary function	six minute walk test	Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	Pneumonia	1 month after surgery, 6 months after surgery, 1year after surgery
Changes of pulmonary function	forced expiratory volume at one second, forced vital capacity	Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of physical activity	wearable device	Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of physical fitness	muscle strengths	Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of quality of life	quality of life questionnaire	Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of Fatigue	Fatigue questionnaire	Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jae Ill Zo, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2016
• Primary Completion (Actual): November 16, 2020
• Study Completion (Anticipated): December 2, 2023

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; quality of life; Perioperative management; cardiopulmonary function; comprehensive intervention; health behavior model
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2015-11-025-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No