Trial Outcomes & Findings for Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes (NCT NCT04342260)
NCT ID: NCT04342260
Last Updated: 2025-02-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
12 months post-discharge
Results posted on
2025-02-20
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
57
|
|
Overall Study
Started ePROs
|
50
|
49
|
|
Overall Study
Completed ePROs
|
47
|
45
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
28
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
Baseline characteristics by cohort
| Measure |
Active Monitoring
n=56 Participants
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.
|
Passive Monitoring
n=57 Participants
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.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-65 years
|
38 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 number of participants
n=5 Participants
|
57 number of participants
n=7 Participants
|
113 number of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months post-dischargePopulation: Intent to treat population.
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.
Outcome measures
| Measure |
Active Monitoring
n=50 Participants
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.
|
Passive Monitoring
n=49 Participants
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.
|
|---|---|---|
|
Quality of Life at 12 Months
|
80.97 units on a scale
Standard Deviation 17.06
|
84.02 units on a scale
Standard Deviation 16.58
|
PRIMARY outcome
Timeframe: 12 months post-dischargePopulation: Intent to treat population.
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
Outcome measures
| Measure |
Active Monitoring
n=50 Participants
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.
|
Passive Monitoring
n=49 Participants
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.
|
|---|---|---|
|
Lung Cancer Specific Quality of Life at 12 Months
Peripheral neuropathy
|
26.19 units on a scale
Standard Deviation 34.38
|
13.1 units on a scale
Standard Deviation 20.96
|
|
Lung Cancer Specific Quality of Life at 12 Months
Coughing
|
22.62 units on a scale
Standard Deviation 24.09
|
30.95 units on a scale
Standard Deviation 22.09
|
|
Lung Cancer Specific Quality of Life at 12 Months
Pain in chest
|
15.48 units on a scale
Standard Deviation 27.94
|
9.52 units on a scale
Standard Deviation 17.82
|
|
Lung Cancer Specific Quality of Life at 12 Months
Pain in arm or shoulder
|
21.43 units on a scale
Standard Deviation 26
|
10.71 units on a scale
Standard Deviation 22.32
|
|
Lung Cancer Specific Quality of Life at 12 Months
Pain in other parts
|
30.95 units on a scale
Standard Deviation 32.62
|
21.43 units on a scale
Standard Deviation 28.99
|
|
Lung Cancer Specific Quality of Life at 12 Months
Dyspnea
|
20.09 units on a scale
Standard Deviation 22
|
23.81 units on a scale
Standard Deviation 24.51
|
PRIMARY outcome
Timeframe: 3 months post-dischargePopulation: Intent to treat population.
The percentage of subjects who completed symptom surveys out of delivered symptom surveys.
Outcome measures
| Measure |
Active Monitoring
n=50 Participants
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.
|
Passive Monitoring
n=49 Participants
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.
|
|---|---|---|
|
PRO Symptom Monitoring Surveys Completed at 3 Months
|
61.1 percentage of participants completed
|
50.30 percentage of participants completed
|
PRIMARY outcome
Timeframe: 3 months post-dischargePopulation: Intent to treat
The percentage of survey alerts that generate a clinician response will be calculated.
Outcome measures
| Measure |
Active Monitoring
n=50 Participants
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.
|
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.
|
|---|---|---|
|
PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months
|
64 percentage of participants received aler
|
—
|
PRIMARY outcome
Timeframe: assessed at 2 months through 2 years post-dischargePopulation: 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.
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.
Outcome measures
| Measure |
Active Monitoring
n=16 Participants
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.
|
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.
|
|---|---|---|
|
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
Patients preferred engagement on ePRO participation with the surgical care team.
|
1 Themes
|
—
|
|
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
Symptoms and physical functioning during surgical recovery were barriers to ePRO completion.
|
1 Themes
|
—
|
|
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
|
—
|
|
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
Participants reported ease of completing the ePRO assessments.
|
1 Themes
|
—
|
|
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
Participants reported irrelevant or repeated ePRO monitoring questions.
|
1 Themes
|
—
|
|
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
|
—
|
|
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
Participants reported increased awareness of their symptoms and recovery with ePRO use.
|
1 Themes
|
—
|
SECONDARY outcome
Timeframe: 3 months post-dischargePopulation: Intent to treat
Readmission rates after thoracic surgery.
Outcome measures
| Measure |
Active Monitoring
n=50 Participants
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.
|
Passive Monitoring
n=49 Participants
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.
|
|---|---|---|
|
Readmission at 3 Months
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 months post-dischargePopulation: Intent to treat
Survival will be compared between arms using Cox proportional hazards regression model.
Outcome measures
| Measure |
Active Monitoring
n=50 Participants
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.
|
Passive Monitoring
n=49 Participants
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.
|
|---|---|---|
|
Overall Survival at 12 Months
|
47 Participants
|
47 Participants
|
Adverse Events
Active Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Passive Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amanda Gentry
University of North Carolina Lineberger Comprehensive Cancer Center
Phone: (336) 655-7743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place