Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
1 other identifier
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Sep 2021
Typical duration for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2021
CompletedFirst Submitted
Initial submission to the registry
September 17, 2021
CompletedFirst Posted
Study publicly available on registry
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedNovember 21, 2022
November 1, 2022
3 years
September 17, 2021
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Quality of life (EORTC QLQ-C30)
Before surgery (baseline) and 1, 6, 12 months after surgery
Lung cancer specific symptoms
Before surgery (baseline) and 1, 6, 12 months after surgery
Dyspnea (mMRC)
Before surgery (baseline) and 1, 6, 12 months after surgery
Dyspnea (CAT)
Before surgery (baseline) and 1, 6, 12 months after surgery
Unmet Needs
Before surgery (baseline) and 1, 6, 12 months after surgery
- +4 more secondary outcomes
Study Arms (2)
Comprehensive care program
EXPERIMENTALIntervention group receiving newly developed comprehensive care program pre- and post-operatively.
Usual care
ACTIVE COMPARATORControl group receiving usual care
Interventions
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 includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
Related Publications (1)
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.
PMID: 38349712DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Wook Shin, MD., Ph.D.
Samsung Medical Center, Seoul, Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Family Medicine
Study Record Dates
First Submitted
September 17, 2021
First Posted
October 15, 2021
Study Start
September 8, 2021
Primary Completion
September 8, 2024
Study Completion
February 28, 2025
Last Updated
November 21, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share