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

November 16, 2022 updated by: Dong Wook Shin, Samsung Medical Center

Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive care program
Intervention group receiving newly developed comprehensive care program pre- and post-operatively.
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.
Other Names:
  • Education and re-evaluation process
Active Comparator: Usual care
Control group receiving usual care
Other: 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.
Other Names:
  • Providing usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental adjustment to cancer at 6 months after surgery
Time Frame: 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Ministry of Science and ICT, Korea

Investigators

  • Principal Investigator: Dong Wook Shin, MD., Ph.D., Samsung medical center, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Anticipated)

September 8, 2024

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2021-08-071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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