Lung Cancer Clinical Trial
Official title:
Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
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.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | February 28, 2025 |
Est. primary completion date | September 8, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with non-small cell lung cancer(NSCLC) and scheduled for curative resection. - NSCLC with clinical stage ?-? - 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | Ministry of Science and ICT, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mental adjustment to cancer at 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. | 6 months after surgery | |
Secondary | Quality of life (EORTC QLQ-C30) | The quality of life is assessed by the European Organization for Research Treatment of Cancer Quality of Life Questionnaire core30 (EORTC QLQ-C30). The scale for quality of life is transformed into a score from 0 to 100, derived by 4-point Likert scale. Higher scores represent a better quality of life. | Before surgery (baseline) and 1, 6, 12 months after surgery | |
Secondary | Lung cancer specific symptoms | The symptoms are assessed by the European Organization for Research Treatment of Cancer Quality of Life Questionnaire lung cancer module 13 (EORTC QLQ-LC13). The scale for symptom is transformed into a score from 0 to 100, derived by 4-point Likert scale. Higher scores mean a more burden of disease. | Before surgery (baseline) and 1, 6, 12 months after surgery | |
Secondary | Dyspnea (mMRC) | Dyspnea is measured by the modified Medical Research Council Dyspnea Scale (mMRC). The mMRC scales grade 0 to grade 4, based on the severity of dyspnea. | Before surgery (baseline) and 1, 6, 12 months after surgery | |
Secondary | Dyspnea (CAT) | Dyspnea is also measured by COPD Assessment Test (CAT). Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. | Before surgery (baseline) and 1, 6, 12 months after surgery | |
Secondary | Unmet Needs | Unmet needs are assessed by the Cancer Survivors' Unmet Needs (CaSUN). There are 5 domains; existential survivorship (14-item), Comprehensive Cancer Care (6-item), Information (3-item), Quality of Life (2-item), Relationships (3-item). It assesses the unmet needs and strength of needs. In this study, only the information domain is investigated. | Before surgery (baseline) and 1, 6, 12 months after surgery | |
Secondary | Anxiety and depression | Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item instrument that reflects two dimensions; depression (seven items) and anxiety (seven items). Each item is rated on a 4-point scale from 0 to 3, with a maximum of 21 for anxiety and depression. | Before surgery (baseline) and 6, 12 months after surgery | |
Secondary | Physical Activity | Physical activity is assessed by International Physical Activity Questionnaire-7 (IPAQ-7). This questionnaire measures duration (minutes) and frequency (days) of physical activity in the last 7 days. | Before surgery (baseline) and 1, 6, 12 months after surgery | |
Secondary | Mental adjustment to cancer | 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. | Before surgery (baseline) and 12 months after surgery | |
Secondary | Distress | NCCN Distress Thermometer & Problem List | Before surgery (baseline) and 1, 6, 12 months after surgery |
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