Lung CancerNCT03215537
Development of Patient Tailored Guideline of Physical Activity for Lung Cancer
A study testing comprehensive intervention in people with Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- comprehensive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2016to 2 Dec 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer patients before surgery
Who cannot join
- Eastern Cooperative Oncology Group Performance Status <1
- Neoadjuvant therapy
- Multiple cancer
- Recurrent lung cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Patient Tailored Guideline of Physical Activity for Lung Cancer Survivor After Surgery; to Improve the Symptoms, Complications and Quality of Life
This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following
Read the detailed description
This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following:
- understanding multi-dimensional factors affecting cardiopulmonary function and quality of life
- development of multidisciplinary comprehensive intervention
- evaluation the effects of comprehensive intervention using cluster design
- Conditions
- Lung Cancer
- Being tested
- comprehensive intervention
- Keywords
- physical activity, cardiopulmonary function, quality of life, Perioperative management, comprehensive intervention, health behavior model
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive interventionBehavioural
preoperative and postoperative exercise program
| Study group | Role | What they receive |
|---|---|---|
| observation | No intervention | No Intervention |
| comprehensive intervention | Active comparator | preoperative: exercise counseling postoperative : symptoms counseling and pulmonary rehabilitation Receives: Behavioral: comprehensive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cardiopulmonary function
six minute walk test
Measured: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Secondary outcomes (6)
complication
Pneumonia
Measured: 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of pulmonary function
forced expiratory volume at one second, forced vital capacity
Measured: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of physical activity
wearable device
Measured: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of physical fitness
muscle strengths
Measured: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of quality of life
quality of life questionnaire
Measured: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of Fatigue
Fatigue questionnaire
Measured: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start2 Mar 2016
- Primary completion16 Nov 2020
- Study completion2 Dec 2023 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae Ill Zo, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215537
- Sponsor's protocol ID
- 2015-11-025-002
- Status last verified
- Feb 2021
- First submitted
- 5 Jul 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee J, Kong S, Shin S, Lee G, Kim HK, Shim YM, Cho J, Kang D, Park HY. Wearable Device-Based Intervention for Promoting Patient Physical Activity After Lung Cancer Surgery: A Nonrandomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434180. doi: 10.1001/jamanetworkopen.2024.34180.
PubMed 39302678
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Patient Tailored Guideline of Physical Activity for Lung Cancer Survivor After Surgery; to Improve the Symptoms, Complications and Quality of Life
- ClinicalTrials.gov ID
- NCT03215537
- Acronym / sponsor ID
- 2015-11-025-002
- Conditions
- Lung Cancer
- Keywords
- physical activity, cardiopulmonary function, quality of life, Perioperative management, comprehensive intervention, health behavior model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 12 Jul 2017 (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.
This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following
Detailed description
This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following:
- understanding multi-dimensional factors affecting cardiopulmonary function and quality of life
- development of multidisciplinary comprehensive intervention
- evaluation the effects of comprehensive intervention using cluster design
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation | No intervention | –No Intervention |
| comprehensive intervention | Active comparator | Behavioral: comprehensive interventionpreoperative: exercise counseling postoperative : symptoms counseling and pulmonary rehabilitation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lung cancer patients before surgery
Key exclusion criteria (4 listed)
- Eastern Cooperative Oncology Group Performance Status <1
- Neoadjuvant therapy
- Multiple cancer
- Recurrent lung cancer.
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 interventionpreoperative and postoperative exercise program | Behavioural | comprehensive intervention |
Primary outcome
Changes of cardiopulmonary function
Time frame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
six minute walk test
6 secondary outcomes
complication
Time frame: 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of pulmonary function
Time frame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of physical activity
Time frame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of physical fitness
Time frame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of quality of life
Time frame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Changes of Fatigue
Time frame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 39302678Lee J, Kong S, Shin S, Lee G, Kim HK, Shim YM, Cho J, Kang D, Park HY. Wearable Device-Based Intervention for Promoting Patient Physical Activity After Lung Cancer Surgery: A Nonrandomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434180. doi: 10.1001/jamanetworkopen.2024.34180.
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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.
Jae Ill Zo principal investigator
Samsung Medical Center
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 intervention in people with Lung Cancer, 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 1 inclusion and 4 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 17 Mar 2021. 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?
Changes of cardiopulmonary function (time frame: Baseline, 1 month after surgery, 6 months after surgery, 1year 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 NCT03215537, 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 17 Mar 2021.