Thoracic SurgeryNCT04342260
Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
A study testing Active Monitoring and Passive Monitoring in people with Thoracic Surgery, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization in thoracic surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Active Monitoring and Passive Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 18 years or older
- English speaking
- Able and willing to complete web-based symptom survey
- Be presenting for inpatient thoracic surgery
Who cannot join
- Not completing planned surgery within 3 months of obtaining informed consent
- Diagnosis of esophageal cancer
- Inability to read and speak English
- Presenting for a day surgery
- Presenting for foregut surgery (e.g. paraesophageal hernia repair)
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Current incarceration
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization in thoracic surgery patients. Patients undergoing thoracic surgery will be asked to self-report symptoms for remote monitoring by their care team.
Read the detailed description
This is a single center, randomized feasibility study. A total of 140 patients undergoing thoracic surgery will be prospectively enrolled and randomized in a 1:1 ratio to one of two arms. All participants will complete patient-reported outcome (PRO) symptom monitoring. The two arms are 1) active symptom monitoring and 2) passive symptom monitoring. The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported. Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician. All participants will be administered survey instruments to assess quality of life, satisfaction, and health history. In addition, a subset of up to 40 participants will be chosen at 2 months postoperatively to complete a semi-structured interview about their postoperative symptom reporting experience.
- Conditions
- Thoracic Surgery
- Being tested
- Active Monitoring, Passive Monitoring
- Keywords
- Patient-Reported Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active MonitoringOther
The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported.
Passive MonitoringOther
Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.
| Study group | Role | What they receive |
|---|---|---|
| Active Monitoring | Experimental | Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms. Receives: Other: Active Monitoring |
| Passive Monitoring | Active comparator | Clinicians will not receive any symptom alerts. Receives: Other: Passive Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life at 12 Months
Quality of Life (QOL) will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) version 3.0 and reported as a score on a scale from 0 to 100 with a higher score being a better QOL.
Measured: 12 months post-discharge
Lung Cancer Specific Quality of Life at 12 Months
Lung cancer specific Quality of Life will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) supplement and reported as a score from 0 to 100 with a higher score being worse symptoms
Measured: 12 months post-discharge
PRO Symptom Monitoring Surveys Completed at 3 Months
The percentage of subjects who completed symptom surveys out of delivered symptom surveys.
Measured: 3 months post-discharge
PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months
The percentage of survey alerts that generate a clinician response will be calculated.
Measured: 3 months post-discharge
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
Barriers and facilitators of PRO monitoring after thoracic surgery will be assessed using qualitative methods. A subset of patients and caregivers participated in semi-structured interviews. Thematic analysis was used to identify determinants.
Measured: assessed at 2 months through 2 years post-discharge
Secondary outcomes (2)
Readmission at 3 Months
Readmission rates after thoracic surgery.
Measured: 3 months post-discharge
Overall Survival at 12 Months
Survival will be compared between arms using Cox proportional hazards regression model.
Measured: 12 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start30 Apr 2020
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Thoracic Surgery Foundation, American College of Surgeons
- Responsible party
- Sponsor
- Investigators
- Gita Mody, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342260
- Sponsor's protocol ID
- LCCC1945
- Status last verified
- Jan 2025
- First submitted
- 24 Mar 2020
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans as of now to make IPD available to other researchers.
Publications
Cox CE, Deal AM, Wang M, Williams B, Gentry AL, Hoch C, Schlusser C, Shrestha S, Boisson-Walsh A, Kurz C, Happ M, Bright A, Hill L, Coleman J, Long J, Haithcock B, Bennett AV, Basch E, Mody GN. Quality of life during electronic patient-reported outcome (ePRO) monitoring in thoracic surgery patients: a pilot randomized controlled trial. Qual Life Res. 2026 Apr 1;35(5):118. doi: 10.1007/s11136-026-04215-x.
PubMed 41920389Boisson-Walsh A, Cox C, O'Leary M, Shrestha S, Carr P, Gentry AL, Hill L, Newsome B, Long J, Haithcock B, Stover AM, Basch E, Leeman J, Mody GN. A Qualitative Study of Electronic Patient-Reported Outcome Symptom Monitoring After Thoracic Surgery. J Surg Res. 2024 Nov;303:744-755. doi: 10.1016/j.jss.2024.09.051. Epub 2024 Oct 25.
PubMed 39461326
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT04342260
- Acronym / sponsor ID
- LCCC1945
- Conditions
- Thoracic Surgery
- Keywords
- Patient-Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Thoracic Surgery Foundation, American College of Surgeons
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization in thoracic surgery patients. Patients undergoing thoracic surgery will be asked to self-report symptoms for remote monitoring by their care team.
Detailed description
This is a single center, randomized feasibility study. A total of 140 patients undergoing thoracic surgery will be prospectively enrolled and randomized in a 1:1 ratio to one of two arms. All participants will complete patient-reported outcome (PRO) symptom monitoring. The two arms are 1) active symptom monitoring and 2) passive symptom monitoring. The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported. Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician. All participants will be administered survey instruments to assess quality of life, satisfaction, and health history. In addition, a subset of up to 40 participants will be chosen at 2 months postoperatively to complete a semi-structured interview about their postoperative symptom reporting experience.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Monitoring | Experimental | Other: Active MonitoringClinicians will receive symptom alerts if the survey suggests increased or worsening symptoms. |
| Passive Monitoring | Active comparator | Other: Passive MonitoringClinicians will not receive any symptom alerts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- English speaking
- Able and willing to complete web-based symptom survey
- Be presenting for inpatient thoracic surgery
Key exclusion criteria (8 listed)
- Not completing planned surgery within 3 months of obtaining informed consent
- Diagnosis of esophageal cancer
- Inability to read and speak English
- Presenting for a day surgery
- Presenting for foregut surgery (e.g. paraesophageal hernia repair)
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 |
|---|---|---|
| Active MonitoringThe participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported. | Other | Active Monitoring |
| Passive MonitoringParticipants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician. | Other | Passive Monitoring |
Primary outcome
Quality of Life at 12 Months
Time frame: 12 months post-discharge
Quality of Life (QOL) will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) version 3.0 and reported as a score on a scale from 0 to 100 with a higher score being a better QOL.
Lung Cancer Specific Quality of Life at 12 Months
Time frame: 12 months post-discharge
Lung cancer specific Quality of Life will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) supplement and reported as a score from 0 to 100 with a higher score being worse symptoms
PRO Symptom Monitoring Surveys Completed at 3 Months
Time frame: 3 months post-discharge
The percentage of subjects who completed symptom surveys out of delivered symptom surveys.
PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months
Time frame: 3 months post-discharge
The percentage of survey alerts that generate a clinician response will be calculated.
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
Time frame: assessed at 2 months through 2 years post-discharge
Barriers and facilitators of PRO monitoring after thoracic surgery will be assessed using qualitative methods. A subset of patients and caregivers participated in semi-structured interviews. Thematic analysis was used to identify determinants.
2 secondary outcomes
Readmission at 3 Months
Time frame: 3 months post-discharge
Overall Survival at 12 Months
Time frame: 12 months post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41920389Cox CE, Deal AM, Wang M, Williams B, Gentry AL, Hoch C, Schlusser C, Shrestha S, Boisson-Walsh A, Kurz C, Happ M, Bright A, Hill L, Coleman J, Long J, Haithcock B, Bennett AV, Basch E, Mody GN. Quality of life during electronic patient-reported outcome (ePRO) monitoring in thoracic surgery patients: a pilot randomized controlled trial. Qual Life Res. 2026 Apr 1;35(5):118. doi: 10.1007/s11136-026-04215-x.
- Derived from this study: PubMed 39461326Boisson-Walsh A, Cox C, O'Leary M, Shrestha S, Carr P, Gentry AL, Hill L, Newsome B, Long J, Haithcock B, Stover AM, Basch E, Leeman J, Mody GN. A Qualitative Study of Electronic Patient-Reported Outcome Symptom Monitoring After Thoracic Surgery. J Surg Res. 2024 Nov;303:744-755. doi: 10.1016/j.jss.2024.09.051. Epub 2024 Oct 25.
- Individual participant dataSharing planned: No. No plans as of now to make IPD available to other researchers.
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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.
Gita Mody, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Monitoring and Passive Monitoring in people with Thoracic Surgery, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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 4 inclusion and 8 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 20 Feb 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quality of Life at 12 Months (time frame: 12 months post-discharge). The study lists 5 primary outcomes in all. 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 NCT04342260, which also lists 2 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 20 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.