Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors

NCT ID: NCT05078918

Last Updated: 2022-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2025-02-28

Brief Summary

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The purpose of this study is to develop a comprehensive care program for their return to normal life and community among lung cancer survivors and evaluate the effectiveness of the program.

Detailed Description

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Lung cancer patients scheduled for curative surgery will be enrolled in this study. The comprehensive care program will be developed, and provided to the intervention group before and after surgery. Outcomes will be assessed 6 months and 1 year after surgery. To evaluate the effectiveness of the program, a control group will be enrolled first and used as a comparator.

Conditions

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Lung Cancer Lung Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Comprehensive care program

Intervention group receiving newly developed comprehensive care program pre- and post-operatively.

Group Type EXPERIMENTAL

Comprehensive care program

Intervention Type OTHER

Comprehensive care program includes education and re-evaluation process. Education using video-materials to help patients adapt to the new normal before and after surgery. And re-evaluation patient's needs 1 month after surgery and arrangement resources.

Usual care

Control group receiving usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery.

Interventions

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Comprehensive care program

Comprehensive care program includes education and re-evaluation process. Education using video-materials to help patients adapt to the new normal before and after surgery. And re-evaluation patient's needs 1 month after surgery and arrangement resources.

Intervention Type OTHER

Usual care

Usual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery.

Intervention Type OTHER

Other Intervention Names

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Education and re-evaluation process Providing usual care

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with non-small cell lung cancer(NSCLC) and scheduled for curative resection.
* NSCLC with clinical stage Ⅰ-Ⅲ
* Patients who understood the study and gave written informed consent.

Exclusion Criteria

* Recurred lung cancer
* Patients with extra-pulmonary synchronous double primary cancer.
* Patients with history of other cancer diagnosis or treatment in the last 3 years.

Drop Criteria:

* When surgery was canceled or pathologic stage IV was confirmed after surgery.
* When the tumor was not found to be non-small cell lung cancer, including benign tumor, after surgery
* Withdrawal informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and ICT, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dong Wook Shin

Professor of Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Wook Shin, MD., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Seoul, Korea

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Wook Shin, MD., Ph.D.

Role: CONTACT

82-2-3410-1062

Genehee Lee, APN., M.S.N.

Role: CONTACT

82-2-3410-1062

Facility Contacts

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Dong Wook Shin, MD., PhD.

Role: primary

82-2-3410-1062

Genehee Lee, APN., M.S.N.

Role: backup

82-2-3410-1062

References

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Jung W, Ahn A, Lee G, Kong S, Kang D, Lee D, Kim TE, Shim YM, Kim HK, Cho J, Cho J, Shin DW. Supporting Life Adjustment in Patients With Lung Cancer Through a Comprehensive Care Program: Protocol for a Controlled Before-and-After Trial. JMIR Res Protoc. 2024 Feb 13;13:e54707. doi: 10.2196/54707.

Reference Type DERIVED
PMID: 38349712 (View on PubMed)

Other Identifiers

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SMC 2021-08-071

Identifier Type: -

Identifier Source: org_study_id

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