Meaning of Recovery After Lung Cancer Surgery

July 22, 2022 updated by: Hojin Lee, MD, Seoul National University Hospital

Meaning of Recovery to Patients Undergoing Lung Cancer Surgery: A Prospective Observational Study

The purpose of this study is to find out the meaning of recovery after lung cancer surgery from a patient's point of view. The results of this study would help improve postoperative recovery in lung cancer patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

In patients undergoing video-assisted thoracic surgery (VATS) lung resection for lung cancer, the survey on the 'meaning of recovery after surgery' are conducted before surgery, 2 days after surgery, and 30 days after surgery. The questionnaire includes importance score of each question regarding the meaning of recovery after lung cancer surgery.

After 2 days of surgery and 30 days after surgery, the questionnaire about the recovery score and the part where the patients felt difficulties are conducted to investigate what recovery means from a patient's point of view. Length of hospital and ICU stay and postoperative complications are also evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 19 to 80 years undergoing video-assisted thoracic surgery (VATS) lung resection for lung cancer

Description

Inclusion Criteria:

  • Patients aged 19 to 80 years undergoing video-assisted thoracic surgery (VATS) lung resection for lung cancer
  • Patients who can provide written consent to participate in clinical trials, understand the procedures of this clinical trial, and properly fill out patient-reported questionnaires or respond appropriately to interviews

Exclusion Criteria:

  • Patients who did not consent to the trial
  • Patients who have difficulty filling out questionnaires or answering interviews about the meaning of recovery
  • Patients judged to be inappropriate for this clinical trial based on the opinion of the investigator or investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Importance score of each question regarding the meaning of recovery after lung cancer surgery before surgery
Time Frame: 1 day before surgery
Importance score of each question regarding the meaning of recovery after lung cancer surgery. The survey includes questions about returning to daily life, resolution of symptoms, overcoming mental strains, regaining independence, and enjoying life. Each question is evaluated on a scale of 1-5, higher number means more importance to the patient.
1 day before surgery
Importance score of each question regarding the meaning of recovery after lung cancer surgery at postoperative day 2
Time Frame: postoperative day 2
Importance score of each question regarding the meaning of recovery after lung cancer surgery. The survey includes questions about returning to daily life, resolution of symptoms, overcoming mental strains, regaining independence, and enjoying life. Each question is evaluated on a scale of 1-5, higher number means more importance to the patient.
postoperative day 2
Importance score of each question regarding the meaning of recovery after lung cancer surgery at postoperative day 30
Time Frame: postoperative day 30 (between day 25 and 35)
Importance score of each question regarding the meaning of recovery after lung cancer surgery. The survey includes questions about returning to daily life, resolution of symptoms, overcoming mental strains, regaining independence, and enjoying life. Each question is evaluated on a scale of 1-5, higher number means more importance to the patient.
postoperative day 30 (between day 25 and 35)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery score (0~100 scale)
Time Frame: postoperative day 2, and postoperative day 30 (between day 25 and 35)
Patient self-assessed recovery score (0-100 scale, higher number means better recovery)
postoperative day 2, and postoperative day 30 (between day 25 and 35)
Recovery score evaluated with 15-item Quality of Recovery (QoR-15K) scale
Time Frame: postoperative day 2
Recovery score evaluated with QoR-15K scale (0-150 scale, higher number means better recovery)
postoperative day 2
Length of hospital stay (day)
Time Frame: Hospital discharge, an average of 3 days
Days from the end of surgery to discharge
Hospital discharge, an average of 3 days
Length of ICU stay (day)
Time Frame: ICU discharge, an average of 1 day
Days from the end of surgery to ICU discharge
ICU discharge, an average of 1 day
Postoperative complication
Time Frame: Postoperative day 30
Postoperative complication related to surgery until postoperative day 30
Postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Recovery_lung

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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