Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

Study Overview
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Brief Summary
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The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.

Official Title
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Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log
* Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Diagnosis of esophageal cancer, stages I-IIIC, with no prior esophageal resection. Neoadjuvant therapy given prior to presentation at MSKCC will be accepted. Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, thoracoabdominal, or McKeown procedure) of esophageal cancer either by open or minimally invasive methods Chest and abdomen CT scan Ability to speak read and write English. Exclusion Criteria: Inability to give informed consent Patients requiring a laryngectomy or colon interposition as part of their surgical resection. Patients with scleroderma.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pts having Minimally Invasive esophagectomy<br>This is a prospective non-randomized study comprising two surgical cohorts of esophageal cancer patients. Patients will be assigned to each of the two intervention groups, MIE versus OE, based on a combination of patient referral patterns, patient preference, and surgeon preference/expertise. | Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log<br>* Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.<br>|
| Pts having open esophagectomy<br>This is a prospective non-randomized study comprising two surgical cohorts of esophageal cancer patients. Patients will be assigned to each of the two intervention groups, MIE versus OE, based on a combination of patient referral patterns, patient preference, and surgeon preference/expertise. | Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log<br>* Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short-term pain | Pain intensity (average of the four pain severity items) measured by BPI at Post-op Days 1 and 3, after epidural removal, at first post-operative clinic visit, at 4 months | 4 months | 
| short -term quality of life (QOL) | FACT-E score at the post-op visit and at the 4 months | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term pain | Pain intensity assessed by BPI at 8 months, 12 months, 18 months, 24 months (average of the four pain severity items) Presence of symptoms with intensity ≥3, as assessed by the Symptom Assessment Scale at post-op visit, at 4 months visit (adjusted for pre-operative symptom intensity ) | 2 years | 
| long time quality of life (QOL) | FACT- E score at 8 months, 12 months, 18 months, 24 months. Presence of symptoms with intensity ≥3, assessed by the Symptom Assessment Scale at 8 months, 12 months, 18 months, 24 months | 2 years | 
| differences in surgical outcomes | operative time, estimated blood loss, length of hospital stay, ICU admission rates, ICU days, complication type, rates and severity as determined by the Common Terminology Criteria for Adverse Events (CTCAE) utilized by MSKCC, rate of anastomotic leak, rate of anastomotic stricture, 90-day (post-operative) hospital readmission rates, time to oral intake, and time to first ambulation. | 90 days | 
| Complications | operative time, estimated blood loss, length of hospital stay, ICU admission rates, ICU days, complication type, rates and severity as determined by the Common Terminology Criteria for Adverse Events (CTCAE) utilized by MSKCC, rate of anastomotic leak, rate of anastomotic stricture, 90-day (post-operative) hospital readmission rates, time to oral intake, and time to first ambulation. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Esophagectomy, Open Esophagectomy, Quality of Life, 12-003