Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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 40 participants and their caregivers will be chosen at 2 months postoperatively to complete a semi-structured interview about their postoperative symptom reporting experience.

Official Title
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Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes

Conditions
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Thoracic Surgery

Intervention / Treatment
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* Other: Active Monitoring
* Other: Passive Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients - 18 years or older English speaking Able and willing to complete web-based symptom survey Be presenting for inpatient thoracic surgery Caregivers - 18 years or older English speaking Be a caregiver for a patient who has undergone thoracic surgery and enrolled in the PRO portion of the study Exclusion Criteria: Patients - 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 Caregiver - Inability to read and speak English Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. Current incarceration Not currently providing care for a patient who has undergone thoracic surgery and enrolled in the PRO portion of the study Receiving extensive medical treatment (e.g., caregivers admitted in the intensive care unit)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Monitoring<br>Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms. | Other: Active Monitoring<br>* 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.<br>|
| Active Comparator: Passive Monitoring<br>Clinicians will not receive any symptom alerts. | Other: Passive Monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Baseline through 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 | Baseline through 12 months post-discharge | 
| PRO symptom monitoring surveys completed at 3 months | The percentage of complete symptom surveys out of delivered symptom surveys will be calculated. | Baseline through 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. | Baseline through 3 months post-discharge | 
| Barriers and facilitators of PRO monitoring after thoracic surgery | Semi-structured interviews of patients and caregivers will be analyzed for themes. | 2 months through 2 years post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission at 3 months | Readmission will be compared between arms using Cox proportional hazards regression model. | Baseline through 3 months post-discharge | 
| Overall Survival at 12 months | Survival will be compared between arms using Cox proportional hazards regression model. | Baseline through 12 months post-discharge | 
| Quality of life surveys completed at 2 years | The percentage of complete quality of life surveys out of delivered quality of life surveys will be calculated. The quality of life surveys consist of the EORTC QLQ-C30 and EORTC QLQ-LC13. | Baseline through 2 years post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-Reported Outcomes