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

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Active Monitoring	Active Monitoring	Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.
Passive Monitoring	Passive Monitoring	Clinicians will not receive any symptom alerts.

Primary Outcome Measures

Name	Time	Method
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.
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 Surveys Completed at 3 Months	3 months post-discharge	The percentage of subjects who completed symptom surveys out of delivered symptom surveys.
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.

Secondary Outcome Measures

Name	Time	Method
Readmission at 3 Months	3 months post-discharge	Readmission rates after thoracic surgery.
Overall Survival at 12 Months	12 months post-discharge	Survival will be compared between arms using Cox proportional hazards regression model.