Clinical trial NCT05078918: Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
Official title: Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lung Neoplasm
Keywords: Lung Cancer
Survivorship
Quality of Life
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Science and ICT, Republic of Korea
First posted: 2021-10-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mental adjustment to cancer at 6 months after surgery
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Quality of life (EORTC QLQ-C30)
timeFrame: Before surgery (baseline) and 1, 6, 12 months after surgery
measure: Lung cancer specific symptoms
timeFrame: Before surgery (baseline) and 1, 6, 12 months after surgery
measure: Dyspnea (mMRC)
timeFrame: Before surgery (baseline) and 1, 6, 12 months after surgery
measure: Dyspnea (CAT)
timeFrame: Before surgery (baseline) and 1, 6, 12 months after surgery
measure: Unmet Needs
timeFrame: Before surgery (baseline) and 1, 6, 12 months after surgery
measure: Anxiety and depression
timeFrame: Before surgery (baseline) and 6, 12 months after surgery
measure: Physical Activity
timeFrame: Before surgery (baseline) and 1, 6, 12 months after surgery
measure: Mental adjustment to cancer
timeFrame: Before surgery (baseline) and 12 months after surgery
measure: Distress
timeFrame: Before surgery (baseline) and 1, 6, 12 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Dong Wook Shin, MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: