Patient-reported OutcomesNCT03341377
Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)
An observational study of Patient-reported Outcomes, run by Xiaojun Yang at 6 sites in China.
Trial summary
Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient-reported Outcomes
- How many people
- 512 participants
- Where
- 6 sitesChina
- Study dates
- 21 Nov 2017to 1 Jan 2020
- 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: Lung cancer patients planning to undergo surgery
Who may be able to join
- Be pathologically or clinically diagnosed as primary lung cancer before surgery;
- Plan to undergo a surgical procedure.
Who cannot join
- Aged younger than 18;
- Diagnosis of cognitive impairment or unable to understand the study requirements.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Chengdu Seventh People's Hospital
Chengdu, Sichuan
Chengdu Third People's Hospital
Chengdu, Sichuan
Dazhu County People's Hospital
Dazhou, Sichuan
Jiangyou People's Hospital
Jiangyou, Sichuan, 621700
Zigong First People's Hospital
Zigong, Sichuan, 643000
About this study
Official title: An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer
Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. With at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (MDASI-LC) and quality of life assessments (SIQOL) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. In the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years after surgery.
- Conditions
- Patient-reported Outcomes
- Keywords
- utility parameter, patient-reported outcome, perioperative symptom management, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer surgical patients | Patient-reported symptom assessments in patients undergoing lung cancer surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC
We will use MD Anderson Symptom Inventory lung cancer module (MDASI-LC) to longitudinally assess the perioperative symptom burden for lung cancer patients. The symptom burden will be profiled as symptom severity, frequency of moderate to severe symptom and its interference with daily functioning.
Measured: less than 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start21 Nov 2017
- Primary completion31 Dec 2019
- Study completion1 Jan 2020
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 Patient-reported OutcomesStudies of the same condition, open and under way.
- 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
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaojun Yang
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Sichuan Cancer Hospital and Research Institute, Zigong No.1 Peoples Hospital, Jiangyou People's Hospital, Chengdu Third People's Hospital, Chengdu Seventh People's Hospital, Dazhu County People's Hospital
- Responsible party
- Sponsor-investigator, Xiaojun Yang, Sichuan Cancer Hospital and Research Institute
- Investigators
- Xiaojun Yang, MD, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341377
- Sponsor's protocol ID
- SCCHEC-02-2017-042
- Status last verified
- Oct 2020
- First submitted
- 8 Nov 2017
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao J, Hu X, Wei X, Dai W, Yu H, Tian X, Wang Y, Qin Q, Xu N, Li Y, Li Q, Shi Q, Liu X. Sex-related differences in postoperative patient-reported outcomes among lung cancer patients: a multicenter cohort study. BMC Cancer. 2025 Apr 29;25(1):800. doi: 10.1186/s12885-025-14191-z.
PubMed 40301835Wei X, Yu H, King-Kallimanis B, Liu Y, Huang L, Dai W, Yang D, Zhou X, Li Q, Shi Q. Long-Term Function Recovery Following Upper Versus Lower Lobectomy for Lung Cancer: A Multicenter Longitudinal Cohort Study. Thorac Cancer. 2025 Jan;16(1):e15505. doi: 10.1111/1759-7714.15505. Epub 2024 Dec 13.
PubMed 39670353Dai W, Xie S, Zhang R, Wei X, Wu C, Zhang Y, Feng W, Liao X, Mu Y, Zhou H, Cheng X, Jiang Y, He J, Li Q, Yang X, Shi Q. Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol. BMJ Open. 2019 Oct 28;9(10):e030726. doi: 10.1136/bmjopen-2019-030726.
PubMed 31662377
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT03341377
- Acronym / sponsor ID
- SCCHEC-02-2017-042
- Conditions
- Patient-reported Outcomes
- Keywords
- utility parameter, patient-reported outcome, perioperative symptom management, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Xiaojun YangUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Sichuan Cancer Hospital and Research Institute, Zigong No.1 Peoples Hospital, Jiangyou People's Hospital, Chengdu Third People's Hospital, Chengdu Seventh People's Hospital, Dazhu County People's Hospital
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 14 Nov 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.
Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. With at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (MDASI-LC) and quality of life assessments (SIQOL) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. In the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer surgical patients | – | –Patient-reported symptom assessments in patients undergoing lung cancer surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients planning to undergo surgery
Key inclusion criteria (2 listed)
- Be pathologically or clinically diagnosed as primary lung cancer before surgery;
- Plan to undergo a surgical procedure.
Key exclusion criteria (2 listed)
- Aged younger than 18;
- Diagnosis of cognitive impairment or unable to understand the study requirements.
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
Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC
Time frame: less than 6 weeks
We will use MD Anderson Symptom Inventory lung cancer module (MDASI-LC) to longitudinally assess the perioperative symptom burden for lung cancer patients. The symptom burden will be profiled as symptom severity, frequency of moderate to severe symptom and its interference with daily functioning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 40301835Liao J, Hu X, Wei X, Dai W, Yu H, Tian X, Wang Y, Qin Q, Xu N, Li Y, Li Q, Shi Q, Liu X. Sex-related differences in postoperative patient-reported outcomes among lung cancer patients: a multicenter cohort study. BMC Cancer. 2025 Apr 29;25(1):800. doi: 10.1186/s12885-025-14191-z.
- Derived from this study: PubMed 39670353Wei X, Yu H, King-Kallimanis B, Liu Y, Huang L, Dai W, Yang D, Zhou X, Li Q, Shi Q. Long-Term Function Recovery Following Upper Versus Lower Lobectomy for Lung Cancer: A Multicenter Longitudinal Cohort Study. Thorac Cancer. 2025 Jan;16(1):e15505. doi: 10.1111/1759-7714.15505. Epub 2024 Dec 13.
- Derived from this study: PubMed 31662377Dai W, Xie S, Zhang R, Wei X, Wu C, Zhang Y, Feng W, Liao X, Mu Y, Zhou H, Cheng X, Jiang Y, He J, Li Q, Yang X, Shi Q. Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol. BMJ Open. 2019 Oct 28;9(10):e030726. doi: 10.1136/bmjopen-2019-030726.
- 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.
Xiaojun Yang, MD principal investigator
Sichuan Cancer Hospital and Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient-reported Outcomes, run by Xiaojun Yang at 6 sites in China.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC (time frame: less than 6 weeks). 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 NCT03341377, 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 28 Oct 2020.