Esophageal NeoplasmsNCT03231462
Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients
An observational study of Esophageal Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This prospective cohort study examines the impact of perioperative physical activity on postoperative pulmonary complications among esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Esophageal Neoplasms
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2015to 31 Dec 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with eshophageal cancer and scheduled to receive curative esophagectomy at a single cancer hospital in Seoul, Korea
Who may be able to join
- Patients who are diagnosed with esophageal cancer and scheduled to receive curative esophagectomy
- Patients who are able to read and understand the questionnaire
- Patients who are able to communicate with research personnel
- Patients who recognize the purpose of this study and provide written informed consent
- Patients without treatment for psychiatric disease
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 with recurrent esophageal cancer
- Patients with multiple cancer
- Foreigner or overseas patients who were not able to regularly participate this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Jae Kyung Lee, MSc, +82-2-3410-6491, jk1230.lee@sbri.co.kr
About this study
Official title: Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients: A Prospective Cohort Study
This prospective cohort study examines the impact of perioperative physical activity on postoperative pulmonary complications among esophageal cancer patients.
- Conditions
- Esophageal Neoplasms
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary complications
Incidence of pneumonia and atelectasis
Measured: Within 30 days after surgery
Secondary outcomes (2)
The change of quality of life
The change of quality of life is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core30 (C30). The quality of life scale is transformed into a score 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
The change of symptom
The change of symptoms is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) oesophageal cancer module (OES18). The symptom scale is transformed into a score 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 posted27 Jul 2017
- Study start6 Mar 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Mog Shim, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231462
- Sponsor's protocol ID
- 2014-10-035
- Status last verified
- Sep 2018
- First submitted
- 10 Jul 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03231462
- Acronym / sponsor ID
- 2014-10-035
- Conditions
- Esophageal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 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 prospective cohort study examines the impact of perioperative physical activity on postoperative pulmonary complications among esophageal cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with eshophageal cancer and scheduled to receive curative esophagectomy at a single cancer hospital in Seoul, Korea
Key inclusion criteria (5 listed)
- Patients who are diagnosed with esophageal cancer and scheduled to receive curative esophagectomy
- Patients who are able to read and understand the questionnaire
- Patients who are able to communicate with research personnel
- Patients who recognize the purpose of this study and provide written informed consent
- Patients without treatment for psychiatric disease
Key exclusion criteria (6 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 with recurrent esophageal cancer
- Patients with multiple cancer
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
Pulmonary complications
Time frame: Within 30 days after surgery
Incidence of pneumonia and atelectasis
2 secondary outcomes
The change of quality of life
Time frame: Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months 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 11 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Esophageal Neoplasms
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Young Mog Shim, MD 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?
An observational study of Esophageal 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 5 inclusion and 6 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 11 Oct 2018. 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 Young Mog Shim, MD (+82-2-3410-6491, genehee.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary complications (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.