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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05078918
Other study ID # SMC 2021-08-071
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2021
Est. completion date February 28, 2025

Study information

Verified date November 2022
Source Samsung Medical Center
Contact Dong Wook Shin, MD., Ph.D.
Phone 82-2-3410-1062
Email dongwook.shin@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Comprehensive care program
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.
Usual care
Usual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Samsung Medical Center Ministry of Science and ICT, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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