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

Samsung Medical Center

Status: Enrolling

Conditions: Lung Cancer; Lung Neoplasm

Treatments: Other: Comprehensive care program; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05078918

SMC 2021-08-071

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Comprehensive care program

Experimental group

Description:

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

Treatment:

Other: Comprehensive care program

Usual care

Active Comparator group

Description:

Control group receiving usual care

Treatment:

Other: Usual care