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

Not Applicable

Recruiting

• Conditions: Lung Neoplasm; Lung Cancer
• Interventions: Other: Usual care; Other: Comprehensive care program

• Registration Number: NCT05078918
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-08
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21
• Primary Completion: 2024-09-08
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Control group receiving usual care
Comprehensive care program	Comprehensive care program	Intervention group receiving newly developed comprehensive care program pre- and post-operatively.

Primary Outcome Measures

Name	Time	Method
Mental adjustment to cancer at 6 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life (EORTC QLQ-C30)	Before surgery (baseline) and 1, 6, 12 months after surgery	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.
Lung cancer specific symptoms	Before surgery (baseline) and 1, 6, 12 months after surgery	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.
Dyspnea (mMRC)	Before surgery (baseline) and 1, 6, 12 months after surgery	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.
Dyspnea (CAT)	Before surgery (baseline) and 1, 6, 12 months after surgery	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.
Unmet Needs	Before surgery (baseline) and 1, 6, 12 months after surgery	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.
Anxiety and depression	Before surgery (baseline) and 6, 12 months after surgery	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.
Physical Activity	Before surgery (baseline) and 1, 6, 12 months after surgery	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.
Mental adjustment to cancer	Before surgery (baseline) and 12 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.
Distress	Before surgery (baseline) and 1, 6, 12 months after surgery	NCCN Distress Thermometer \& Problem List

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of