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| Name | Class |
|---|---|
| Ministry of Science and ICT, Republic of Korea | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive care program | Experimental | Intervention group receiving newly developed comprehensive care program pre- and post-operatively. |
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| Usual care | Active Comparator | Control group receiving usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive care program | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Drop Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wook Shin, MD., Ph.D. | Contact | 82-2-3410-1062 | dongwook.shin@samsung.com | |
| Genehee Lee, APN., M.S.N. | Contact | 82-2-3410-1062 | genehee.lee@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Wook Shin, MD., Ph.D. | Samsung Medical Center, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38349712 | Derived | Jung W, Ahn A, Lee G, Kong S, Kang D, Lee D, Kim TE, Shim YM, Kim HK, Cho J, Cho J, Shin DW. Supporting Life Adjustment in Patients With Lung Cancer Through a Comprehensive Care Program: Protocol for a Controlled Before-and-After Trial. JMIR Res Protoc. 2024 Feb 13;13:e54707. doi: 10.2196/54707. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
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| Usual care | Other | Usual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery. |
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| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |