Thoracic SurgeryTSPRO2NCT05311670
Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
An observational study of Thoracic Surgery, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study (LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Patient-reported outcomes monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2022to 10 Oct 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects scheduled thoracic surgery at UNC Chapel Hill Hospital.
Who may be able to join
- 18 years or older
- English speaking
- Able and willing to complete a web-based or telephonic symptom survey
- Planned to undergo surgery within 90 days or have undergone and been discharged from major thoracic surgery within the last 30 days.
Who cannot join
- Not completing planned surgery within 3 months of obtaining informed consent (for subjects recruited preoperatively)
- Inability to read and speak English
- Planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection or repair)
- Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
- Dementia, altered mental status, or any psychiatric condition as determined by thoracic surgery provider team 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
The purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study (LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using web-based or telephone surveys. Patients will be asked to self-report symptoms for remote monitoring by their care team. Patients will be approached for a semi-structured interview to understand the barriers and facilitators to ePRO use.
Read the detailed description
This is a single-site, non-randomized study in patients receiving major thoracic surgery, which commonly involves chest wall incisions and overnight admission Eligible patients will be approached at any time point between their preoperative clinic visit and up to 30 days after discharge from the hospital. Approximately 60 patients will be enrolled in the study. Patients will complete symptom surveys via email or telephone. Concerning symptoms will generate alerts for the clinical care team who will follow their usual protocols for the management of symptoms. Patients will be purposively selected and invited to participate in a semi-structured interview to understand their experience using ePRO. Interviews will continue until 30 complete interviews are obtained and/or thematic saturation is reached.
- Conditions
- Thoracic Surgery
- Being tested
- Patient-reported outcomes monitoring
- Keywords
- Electronic Patient-Reported Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-reported outcomes monitoringBehavioural
Also called Survey
- Patient-reported outcomes will be collected from patients through web or telephone and alerts sent to providers.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Participants will be assigned to the single-arm involving monitoring of their symptoms. Receives: Behavioral: Patient-reported outcomes monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers to use of ePROs among patients
Semi-structured interview with patients to evaluate ePRO use.
Measured: Up to one year (From one month after the study start until the thematic saturation is reached)
Facilitators to use of ePROs among patients
Semi-structured interview with patients to evaluate ePRO use.
Measured: Up to one year (From one month after the study start until the thematic saturation is reached)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start7 Apr 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gita Mody, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311670
- Sponsor's protocol ID
- LCCC 2202
- Other IDs
- 1K23HL157765-01A1
- Acronym
- TSPRO2
- Status last verified
- Dec 2023
- First submitted
- 10 Mar 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan as of now to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
- ClinicalTrials.gov ID
- NCT05311670
- Acronym / sponsor ID
- TSPRO2 / LCCC 2202
- Conditions
- Thoracic Surgery
- Keywords
- Electronic Patient-Reported Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 5 Apr 2022 (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.
The purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study (LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using web-based or telephone surveys. Patients will be asked to self-report symptoms for remote monitoring by their care team. Patients will be approached for a semi-structured interview to understand the barriers and facilitators to ePRO use.
Detailed description
This is a single-site, non-randomized study in patients receiving major thoracic surgery, which commonly involves chest wall incisions and overnight admission Eligible patients will be approached at any time point between their preoperative clinic visit and up to 30 days after discharge from the hospital. Approximately 60 patients will be enrolled in the study. Patients will complete symptom surveys via email or telephone. Concerning symptoms will generate alerts for the clinical care team who will follow their usual protocols for the management of symptoms. Patients will be purposively selected and invited to participate in a semi-structured interview to understand their experience using ePRO. Interviews will continue until 30 complete interviews are obtained and/or thematic saturation is reached.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | – | Behavioral: Patient-reported outcomes monitoringParticipants will be assigned to the single-arm involving monitoring of their symptoms. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled thoracic surgery at UNC Chapel Hill Hospital.
Key inclusion criteria (4 listed)
- 18 years or older
- English speaking
- Able and willing to complete a web-based or telephonic symptom survey
- Planned to undergo surgery within 90 days or have undergone and been discharged from major thoracic surgery within the last 30 days.
Key exclusion criteria (7 listed)
- Not completing planned surgery within 3 months of obtaining informed consent (for subjects recruited preoperatively)
- Inability to read and speak English
- Planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection or repair)
- Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
- Dementia, altered mental status, or any psychiatric condition as determined by thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
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 |
|---|---|---|
| Patient-reported outcomes monitoringAlso: Surveyo Patient-reported outcomes will be collected from patients through web or telephone and alerts sent to providers. | Behavioural | Single-arm |
Primary outcome
Barriers to use of ePROs among patients
Time frame: Up to one year (From one month after the study start until the thematic saturation is reached)
Semi-structured interview with patients to evaluate ePRO use.
Facilitators to use of ePROs among patients
Time frame: Up to one year (From one month after the study start until the thematic saturation is reached)
Semi-structured interview with patients to evaluate ePRO use.
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 20 Dec 2023.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan 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 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?
An observational study of 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 7 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 Dec 2023. 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?
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?
Barriers to use of ePROs among patients (time frame: Up to one year (From one month after the study start until the thematic saturation is reached)). The study lists 2 primary outcomes in all. 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 20 Dec 2023.