Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Mental adjustment to cancer at 6 months after surgery
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Dong Wook Shin
Professor of Family Medicine
Samsung Medical Center
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.
Outcomes
Primary Outcomes
Mental adjustment to cancer at 6 months after surgery
Time Frame: 6 months after surgery
The Mini-Mental Adjustment to Cancer (Mini-MAC) scale, a short form instrument derived from the MAC and designed to measure coping with cancer. The scale consists of 29 items and 5 sub-dimensions as follows: Fighting spirit, helplessness/hopelessness, anxious preoccupation, fatalism and cognitive avoidance. The mini-MAC is a Likert type scale with four response options: (1) definitely does not apply to me (2) does not apply to me (3) applies to me (4) definitely applies to me.
Secondary Outcomes
- Quality of life (EORTC QLQ-C30)(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Lung cancer specific symptoms(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Dyspnea (mMRC)(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Dyspnea (CAT)(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Unmet Needs(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Anxiety and depression(Before surgery (baseline) and 6, 12 months after surgery)
- Physical Activity(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Mental adjustment to cancer(Before surgery (baseline) and 12 months after surgery)
- Distress(Before surgery (baseline) and 1, 6, 12 months after surgery)