Lung CancerNCT05078918
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
A study testing Comprehensive care program in people with Lung Cancer and Lung Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Neoplasm
- What is being tested?
- Comprehensive care program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Sep 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Dong Wook Shin, MD., PhD., 82-2-3410-1062, dongwook.shin@samsung.com
Genehee Lee, APN., M.S.N., 82-2-3410-1062, genehee.lee@samsung.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Lung Neoplasm
- Being tested
- Comprehensive care program, Usual care
- Keywords
- Lung Cancer, Survivorship, Quality of Life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive care programOther
Also called Education and re-evaluation process
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 careOther
Also called Providing 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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive care program | Experimental | Intervention group receiving newly developed comprehensive care program pre- and post-operatively. Receives: Other: Comprehensive care program |
| Usual care | Active comparator | Control group receiving usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (9)
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.
Measured: Before surgery (baseline) and 1, 6, 12 months after surgery
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.
Measured: Before surgery (baseline) and 1, 6, 12 months after surgery
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.
Measured: Before surgery (baseline) and 1, 6, 12 months after surgery
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.
Measured: Before surgery (baseline) and 1, 6, 12 months after surgery
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.
Measured: Before surgery (baseline) and 1, 6, 12 months after surgery
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.
Measured: Before surgery (baseline) and 6, 12 months after surgery
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.
Measured: Before surgery (baseline) and 1, 6, 12 months after surgery
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.
Measured: Before surgery (baseline) and 12 months after surgery
Distress
NCCN Distress Thermometer \& Problem List
Measured: Before surgery (baseline) and 1, 6, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start8 Sep 2021
- Primary completion8 Sep 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Responsible party
- Principal investigator, Dong Wook Shin, Samsung Medical Center
- Investigators
- Dong Wook Shin, MD., Ph.D., Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078918
- Sponsor's protocol ID
- SMC 2021-08-071
- Status last verified
- Nov 2022
- First submitted
- 17 Sep 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38349712
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
- ClinicalTrials.gov ID
- NCT05078918
- Acronym / sponsor ID
- SMC 2021-08-071
- Conditions
- Lung Cancer, Lung Neoplasm
- Keywords
- Lung Cancer, Survivorship, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 8 Sep 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized controlled trial. Control groups will be enrolled first considering contamination of educational intervention.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive care program | Experimental | Other: Comprehensive care programIntervention group receiving newly developed comprehensive care program pre- and post-operatively. |
| Usual care | Active comparator | Other: Usual careControl group receiving usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive care programAlso: Education and re-evaluation processComprehensive 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 | Comprehensive care program |
| Usual careAlso: Providing usual careUsual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery. | Other | Usual care |
Primary outcome
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.
9 secondary outcomes
Quality of life (EORTC QLQ-C30)
Time frame: 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
Dyspnea (mMRC)
Time frame: Before surgery (baseline) and 1, 6, 12 months after surgery
Dyspnea (CAT)
Time frame: Before surgery (baseline) and 1, 6, 12 months after surgery
Unmet Needs
Time frame: Before surgery (baseline) and 1, 6, 12 months after surgery
Anxiety and depression
Time frame: Before surgery (baseline) and 6, 12 months after surgery
Physical Activity
Time frame: Before surgery (baseline) and 1, 6, 12 months after surgery
Mental adjustment to cancer
Time frame: Before surgery (baseline) and 12 months after surgery
Distress
Time frame: Before surgery (baseline) and 1, 6, 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Derived from this study: PubMed 38349712Jung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Wook Shin, MD., Ph.D. principal investigator
Samsung Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive care program in people with Lung Cancer and Lung Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Wook Shin, MD., Ph.D. (82-2-3410-1062, dongwook.shin@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental adjustment to cancer at 6 months after surgery (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05078918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.