Thoracic Surgery
Conditions
Keywords
Patient-Reported Outcomes
Brief 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. 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.
Interventions
OTHERActive 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.
OTHERPassive 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.
Sponsors
Thoracic Surgery Foundation
American College of Surgeons
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * English speaking * Able and willing to complete web-based symptom survey * Be presenting for inpatient thoracic surgery
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Cancer Specific Quality of Life at 12 Months | 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 Alerts Resulting in a Clinician Response at 3 Months | 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 | 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. |
| Quality of Life at 12 Months | 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. |
| PRO Symptom Monitoring Surveys Completed at 3 Months | 3 months post-discharge | The percentage of subjects who completed symptom surveys out of delivered symptom surveys. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival at 12 Months | 12 months post-discharge | Survival will be compared between arms using Cox proportional hazards regression model. |
| Readmission at 3 Months | 3 months post-discharge | Readmission rates after thoracic surgery. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 56 |
| 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. | 57 |
| Total | 113 |
Baseline characteristics
| Characteristic | Active Monitoring | Passive Monitoring | Total |
|---|---|---|---|
| Age, Customized 18-65 years | 38 Participants | 27 Participants | 65 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >65 years | 18 Participants | 29 Participants | 47 Participants |
| Age, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 54 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 11 Participants | 9 Participants | 20 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 39 Participants | 43 Participants | 82 Participants |
| Region of Enrollment United States | 56 number of participants | 57 number of participants | 113 number of participants |
| Sex/Gender, Customized Female | 32 Participants | 38 Participants | 70 Participants |
| Sex/Gender, Customized Male | 24 Participants | 18 Participants | 42 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 50 | 2 / 49 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: assessed at 2 months through 2 years post-discharge
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Monitoring | Barriers and Facilitators of PRO Monitoring After Thoracic Surgery | Symptoms and physical functioning during surgical recovery were barriers to ePRO completion. | 1 Themes |
| Active Monitoring | Barriers and Facilitators of PRO Monitoring After Thoracic Surgery | Access to required technology was a barrier to completing web-based ePROs for a few participants. | 1 Themes |
| Active Monitoring | Barriers and Facilitators of PRO Monitoring After Thoracic Surgery | Participants reported ease of completing the ePRO assessments. | 1 Themes |
| Active Monitoring | Barriers and Facilitators of PRO Monitoring After Thoracic Surgery | Patients preferred engagement on ePRO participation with the surgical care team. | 1 Themes |
| Active Monitoring | Barriers and Facilitators of PRO Monitoring After Thoracic Surgery | Participants reported irrelevant or repeated ePRO monitoring questions. | 1 Themes |
| Active Monitoring | Barriers and Facilitators of PRO Monitoring After Thoracic Surgery | Participants reported a lack of clarity on ePRO assessment integration with routine clinical care. | 1 Themes |
| Active Monitoring | Barriers and Facilitators of PRO Monitoring After Thoracic Surgery | Participants reported increased awareness of their symptoms and recovery with ePRO use. | 1 Themes |
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
Time frame: 12 months post-discharge
Population: Intent to treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Pain in chest | 15.48 units on a scale | Standard Deviation 27.94 |
| Active Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Pain in arm or shoulder | 21.43 units on a scale | Standard Deviation 26 |
| Active Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Pain in other parts | 30.95 units on a scale | Standard Deviation 32.62 |
| Active Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Peripheral neuropathy | 26.19 units on a scale | Standard Deviation 34.38 |
| Active Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Dyspnea | 20.09 units on a scale | Standard Deviation 22 |
| Active Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Coughing | 22.62 units on a scale | Standard Deviation 24.09 |
| Passive Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Dyspnea | 23.81 units on a scale | Standard Deviation 24.51 |
| Passive Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Pain in chest | 9.52 units on a scale | Standard Deviation 17.82 |
| Passive Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Peripheral neuropathy | 13.1 units on a scale | Standard Deviation 20.96 |
| Passive Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Pain in arm or shoulder | 10.71 units on a scale | Standard Deviation 22.32 |
| Passive Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Coughing | 30.95 units on a scale | Standard Deviation 22.09 |
| Passive Monitoring | Lung Cancer Specific Quality of Life at 12 Months | Pain in other parts | 21.43 units on a scale | Standard Deviation 28.99 |
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.
Time frame: 3 months post-discharge
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Monitoring | PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months | 64 percentage of participants received aler |
Primary
PRO Symptom Monitoring Surveys Completed at 3 Months
The percentage of subjects who completed symptom surveys out of delivered symptom surveys.
Time frame: 3 months post-discharge
Population: Intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Monitoring | PRO Symptom Monitoring Surveys Completed at 3 Months | 61.1 percentage of participants completed |
| Passive Monitoring | PRO Symptom Monitoring Surveys Completed at 3 Months | 50.30 percentage of participants completed |
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.
Time frame: 12 months post-discharge
Population: Intent to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Monitoring | Quality of Life at 12 Months | 80.97 units on a scale | Standard Deviation 17.06 |
| Passive Monitoring | Quality of Life at 12 Months | 84.02 units on a scale | Standard Deviation 16.58 |
Secondary
Overall Survival at 12 Months
Survival will be compared between arms using Cox proportional hazards regression model.
Time frame: 12 months post-discharge
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Monitoring | Overall Survival at 12 Months | 47 Participants |
| Passive Monitoring | Overall Survival at 12 Months | 47 Participants |
Secondary
Readmission at 3 Months
Readmission rates after thoracic surgery.
Time frame: 3 months post-discharge
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Monitoring | Readmission at 3 Months | 6 Participants |
| Passive Monitoring | Readmission at 3 Months | 7 Participants |