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| Name | Class |
|---|---|
| Thoracic Surgery Foundation | UNKNOWN |
| American College of Surgeons | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Monitoring | Experimental | Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms. |
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| Passive Monitoring | Active Comparator | Clinicians will not receive any symptom alerts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Monitoring | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 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. | 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. | assessed at 2 months through 2 years post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission at 3 Months | Readmission rates after thoracic surgery. | 3 months post-discharge |
| Overall Survival at 12 Months | Survival will be compared between arms using Cox proportional hazards regression model. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gita Mody, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41920389 | Derived | 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. | |
| 39461326 |
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No plans as of now to make IPD available to other researchers.
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Eligible patients who enrolled were assigned to study arms at the time of enrollment in a 1:1 ratio using block randomization with blocks of 20 participants (patients).
Patients undergoing major thoracic surgery within the Multidisciplinary Thoracic Surgery Program at the University of North Carolina at Chapel Hill between April 2020 and June 2021 who met the inclusion criteria were invited to participate in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Monitoring | Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms. Active 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. |
| FG001 | Passive Monitoring | Clinicians will not receive any symptom alerts. Passive Monitoring: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Monitoring | Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms. Active 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat population. | Posted | Mean | Standard Deviation | units on a scale | 12 months post-discharge |
|
This study protocol does not require Adverse Event reporting, only all-cause mortality up to12 months were reported.
This study protocol does not require Adverse Event reporting, only unanticipated problems involving risks to study subjects or others (UPIRSO) refer to any incident, experience report is required.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Monitoring | Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms. Active 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Gentry | University of North Carolina Lineberger Comprehensive Cancer Center | (336) 655-7743 | agentry@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2023 | Sep 23, 2024 | Prot_SAP_000.pdf |
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| Passive Monitoring | Other | 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. |
|
| 12 months post-discharge |
| Derived |
| Boisson-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. |
| BG001 | Passive Monitoring | Clinicians will not receive any symptom alerts. Passive Monitoring: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | number of participants |
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| OG001 | Passive Monitoring | Clinicians will not receive any symptom alerts. Passive Monitoring: 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. |
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| Primary | 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 | Intent to treat population. | Posted | Mean | Standard Deviation | units on a scale | 12 months post-discharge |
|
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| Primary | PRO Symptom Monitoring Surveys Completed at 3 Months | The percentage of subjects who completed symptom surveys out of delivered symptom surveys. | Intent to treat population. | Posted | Number | percentage of participants completed | 3 months post-discharge |
|
|
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| Primary | 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. | Intent to treat | Posted | Number | percentage of participants received aler | 3 months post-discharge |
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| Primary | 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. | The subset of patients who completed semi-structured interviews included those from both the active and passive monitoring arms and were combined for thematic analysis. No calculations across or between groups were performed for qualitative analyses. Numbers represented here are the number of themes derived from the interviews. | Posted | Number | Themes | assessed at 2 months through 2 years post-discharge |
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| Secondary | Readmission at 3 Months | Readmission rates after thoracic surgery. | Intent to treat | Posted | Count of Participants | Participants | 3 months post-discharge |
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| Secondary | Overall Survival at 12 Months | Survival will be compared between arms using Cox proportional hazards regression model. | Intent to treat | Posted | Count of Participants | Participants | 12 months post-discharge |
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| 3 |
| 50 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Passive Monitoring | Clinicians will not receive any symptom alerts. Passive Monitoring: 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. | 2 | 49 | 0 | 0 | 0 | 0 |
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| Pain in other parts |
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| Peripheral neuropathy |
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| Dyspnea |
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| Coughing |
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| Patients preferred engagement on ePRO participation with the surgical care team. |
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| Participants reported irrelevant or repeated ePRO monitoring questions. |
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| Participants reported a lack of clarity on ePRO assessment integration with routine clinical care. |
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| Participants reported increased awareness of their symptoms and recovery with ePRO use. |
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