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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078918
• Other study ID #: SMC 2021-08-071
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasm
• Lung Neoplasms

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