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

Study Overview
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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.

Official Title
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Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors

Conditions
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Lung Cancer, Lung Neoplasm

Intervention / Treatment
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* Other: Comprehensive care program
* Other: Usual care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive care program<br>Intervention group receiving newly developed comprehensive care program pre- and post-operatively. | Other: Comprehensive care program<br>* 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.<br>* Other names: Education and re-evaluation process;|
| Active Comparator: Usual care<br>Control group receiving usual care | Other: Usual care<br>* Usual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery.<br>* Other names: Providing usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Distress | NCCN Distress Thermometer & Problem List | Before surgery (baseline) and 1, 6, 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Survivorship, Quality of Life