Lung NeoplasmsNCT03705546
The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer
An observational study of Lung Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to examine the impact of physical activity on the postoperative symptoms, complication, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- How many people
- 1,050 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2016to 3 Mar 2026
- Phase
- Observational
- 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
Study population: The study population in this study consists of patients who are diagnosed with lung cancer and scheduled for surgery in a lung cancer center at Seoul.
Who may be able to join
- Patients who are diagnosed with lung cancer
- Patients who are able to walk with ECOG (Eastern Cooperative Oncology Group) performance status < 1
- Patients who understand the purpose of this study and provide the written informed consent
Who cannot join
- Patients who have difficulty for walking
- Patients with history of other cancer in the last 3 years
- Patients with neoadjuvant chemotherapy and/or radiation therapy
- Patients who are diagnosed with recurrent lung cancer or multiple cancer
- Foreigner of patients from overseas who are not able regularly participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer Survivors: A Prospective Cohort Study
The purpose of this study is to examine the impact of physical activity on the postoperative symptoms, complication, and quality of life.
Read the detailed description
Non-small cell lung cancer (NSCLC) survivor is increasing as developing early diagnosis and perioperative management. Despite multidisciplinary treatment, Surgery is the primary treatment option for cure in NSCLC. The patients with lung cancer who underwent surgery have limitation of pulmonary function and high risk of co-morbidities. Perioperative physical activity has been shown to reduce symptoms and prevent complications, improve long term quality of life after surgery. But validated exercise regimen has not been established for lung cancer patients. Therefore, Evidence-based guideline focusing on lung cancer after surgery is needed.
- Conditions
- Lung Neoplasms
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of quality of life: (EORTC QLQ) core30 (C30)
The change of quality of life is measured using the European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core30 (C30). The scale for quality of life is transformed into a score from 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of quality of life.
Measured: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
Secondary outcomes (2)
Postoperative pulmonary complications
Incidence of pulmonary complications including air leak, atelectasis, pleural effusion, pneumonia, etc.
Measured: Within 30 days after surgery
The change of symptom
The change of symptom is measured using the European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) lung cancer module 13 (LC13). The scale for symptom is transformed into a score from 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of symptom.
Measured: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 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 2018
- Study start4 Mar 2016
- Primary completion31 Dec 2020
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Kwan Kim, Ph.D., Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705546
- Sponsor's protocol ID
- SMC 2015-11-025-002(C)
- Status last verified
- May 2024
- First submitted
- 5 Oct 2018
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong S, Shin S, Jeon YJ, Lee G, Cho JH, Kim HK, Shim YM, Cho J, Kang D, Park HY. Factors associated with failure of cardiopulmonary function recovery after lung cancer surgery. Respirology. 2023 Nov;28(11):1060-1068. doi: 10.1111/resp.14581. Epub 2023 Aug 29.
PubMed 37642118Shin S, Kong S, Kang D, Lee G, Cho JH, Shim YM, Cho J, Kim HK, Park HY. Longitudinal changes in pulmonary function and patient-reported outcomes after lung cancer surgery. Respir Res. 2022 Aug 30;23(1):224. doi: 10.1186/s12931-022-02149-9.
PubMed 36042472Lee H, Kim HK, Kang D, Kong S, Lee JK, Lee G, Shin S, Cho J, Zo JI, Shim YM, Park HY. Prognostic Value of 6-Min Walk Test to Predict Postoperative Cardiopulmonary Complications in Patients With Non-small Cell Lung Cancer. Chest. 2020 Jun;157(6):1665-1673. doi: 10.1016/j.chest.2019.12.039. Epub 2020 Jan 25.
PubMed 31987880
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer Survivors: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03705546
- Acronym / sponsor ID
- SMC 2015-11-025-002(C)
- Conditions
- Lung Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 15 Oct 2018 (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 examine the impact of physical activity on the postoperative symptoms, complication, and quality of life.
Detailed description
Non-small cell lung cancer (NSCLC) survivor is increasing as developing early diagnosis and perioperative management. Despite multidisciplinary treatment, Surgery is the primary treatment option for cure in NSCLC. The patients with lung cancer who underwent surgery have limitation of pulmonary function and high risk of co-morbidities. Perioperative physical activity has been shown to reduce symptoms and prevent complications, improve long term quality of life after surgery. But validated exercise regimen has not been established for lung cancer patients. Therefore, Evidence-based guideline focusing on lung cancer after surgery is needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population in this study consists of patients who are diagnosed with lung cancer and scheduled for surgery in a lung cancer center at Seoul.
Key inclusion criteria (3 listed)
- Patients who are diagnosed with lung cancer
- Patients who are able to walk with ECOG (Eastern Cooperative Oncology Group) performance status < 1
- Patients who understand the purpose of this study and provide the written informed consent
Key exclusion criteria (5 listed)
- Patients who have difficulty for walking
- Patients with history of other cancer in the last 3 years
- Patients with neoadjuvant chemotherapy and/or radiation therapy
- Patients who are diagnosed with recurrent lung cancer or multiple cancer
- Foreigner of patients from overseas who are not able regularly participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of quality of life: (EORTC QLQ) core30 (C30)
Time frame: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
The change of quality of life is measured using the European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core30 (C30). The scale for quality of life is transformed into a score from 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of quality of life.
2 secondary outcomes
Postoperative pulmonary complications
Time frame: Within 30 days after surgery
The change of symptom
Time frame: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 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 24 May 2024.
- Derived from this study: PubMed 37642118Kong S, Shin S, Jeon YJ, Lee G, Cho JH, Kim HK, Shim YM, Cho J, Kang D, Park HY. Factors associated with failure of cardiopulmonary function recovery after lung cancer surgery. Respirology. 2023 Nov;28(11):1060-1068. doi: 10.1111/resp.14581. Epub 2023 Aug 29.
- Derived from this study: PubMed 36042472Shin S, Kong S, Kang D, Lee G, Cho JH, Shim YM, Cho J, Kim HK, Park HY. Longitudinal changes in pulmonary function and patient-reported outcomes after lung cancer surgery. Respir Res. 2022 Aug 30;23(1):224. doi: 10.1186/s12931-022-02149-9.
- Derived from this study: PubMed 31987880Lee H, Kim HK, Kang D, Kong S, Lee JK, Lee G, Shin S, Cho J, Zo JI, Shim YM, Park HY. Prognostic Value of 6-Min Walk Test to Predict Postoperative Cardiopulmonary Complications in Patients With Non-small Cell Lung Cancer. Chest. 2020 Jun;157(6):1665-1673. doi: 10.1016/j.chest.2019.12.039. Epub 2020 Jan 25.
- 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.
Hong Kwan Kim, Ph.D. study director
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, 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 5 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 24 May 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of quality of life: (EORTC QLQ) core30 (C30) (time frame: Before surgery (baseline), and 1, 6, 12, 24, 36, 48, and 60 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 NCT03705546, which also lists 3 linked publications.
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 24 May 2024.