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

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05078918
Collaborator
Ministry of Science and ICT, Korea (Other)
600
1
2
41.7
14.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Comprehensive care program
  • Other: Usual care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
Actual Study Start Date :
Sep 8, 2021
Anticipated Primary Completion Date :
Sep 8, 2024
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 06351

    Sponsors and Collaborators

    • Samsung Medical Center
    • Ministry of Science and ICT, Korea

    Investigators

    • Principal Investigator: Dong Wook Shin, MD., Ph.D., Samsung Medical Center, Seoul, Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong Wook Shin, Professor of Family Medicine, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT05078918
    Other Study ID Numbers:
    • SMC 2021-08-071
    First Posted:
    Oct 15, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dong Wook Shin, Professor of Family Medicine, Samsung Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021