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

Primary Purpose

Lung Cancer, Lung Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Comprehensive care program
Usual care
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung Cancer, Survivorship, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • Withdrawal informed consent.

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive care program

Usual care

Arm Description

Intervention group receiving newly developed comprehensive care program pre- and post-operatively.

Control group receiving usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Distress
NCCN Distress Thermometer & Problem List

Full Information

First Posted
September 17, 2021
Last Updated
November 16, 2022
Sponsor
Samsung Medical Center
Collaborators
Ministry of Science and ICT, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05078918
Brief Title
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
Official Title
Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
September 8, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Ministry of Science and ICT, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Neoplasm
Keywords
Lung Cancer, Survivorship, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive care program
Arm Type
Experimental
Arm Description
Intervention group receiving newly developed comprehensive care program pre- and post-operatively.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Control group receiving usual care
Intervention Type
Other
Intervention Name(s)
Comprehensive care program
Other Intervention Name(s)
Education and re-evaluation process
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Providing usual care
Intervention Description
Usual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery.
Primary Outcome Measure Information:
Title
Mental adjustment to cancer at 6 months after surgery
Description
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.
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Quality of life (EORTC QLQ-C30)
Description
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.
Time Frame
Before surgery (baseline) and 1, 6, 12 months after surgery
Title
Lung cancer specific symptoms
Description
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.
Time Frame
Before surgery (baseline) and 1, 6, 12 months after surgery
Title
Dyspnea (mMRC)
Description
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.
Time Frame
Before surgery (baseline) and 1, 6, 12 months after surgery
Title
Dyspnea (CAT)
Description
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.
Time Frame
Before surgery (baseline) and 1, 6, 12 months after surgery
Title
Unmet Needs
Description
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.
Time Frame
Before surgery (baseline) and 1, 6, 12 months after surgery
Title
Anxiety and depression
Description
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.
Time Frame
Before surgery (baseline) and 6, 12 months after surgery
Title
Physical Activity
Description
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.
Time Frame
Before surgery (baseline) and 1, 6, 12 months after surgery
Title
Mental adjustment to cancer
Description
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.
Time Frame
Before surgery (baseline) and 12 months after surgery
Title
Distress
Description
NCCN Distress Thermometer & Problem List
Time Frame
Before surgery (baseline) and 1, 6, 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Wook Shin, MD., Ph.D.
Phone
82-2-3410-1062
Email
dongwook.shin@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Genehee Lee, APN., M.S.N.
Phone
82-2-3410-1062
Email
genehee.lee@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Wook Shin, MD., Ph.D.
Organizational Affiliation
Samsung Medical Center, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Wook Shin, MD., PhD.
Phone
82-2-3410-1062
Email
dongwook.shin@samsung.com
First Name & Middle Initial & Last Name & Degree
Genehee Lee, APN., M.S.N.
Phone
82-2-3410-1062
Email
genehee.lee@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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