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

NCT01558648 | Completed

• 1 other identifier: 12-003
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Keywords

Minimally Invasive Esophagectomy; Open Esophagectomy; Quality of Life; 12-003

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• long-term pain

  2 years

• long time quality of life (QOL)

  2 years

• differences in surgical outcomes

  90 days

• Complications

  90 days

Other Outcomes (2)

• predict EUS T3/T4/stricture disease

  2 years

• predict EUS T3/T4/stricture or earlier EUS disease

  2 years

Study Arms (2)

Pts having Minimally Invasive esophagectomy

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

Pts having open esophagectomy

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

Interventions

Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log BEHAVIORAL

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.

Pts having Minimally Invasive esophagectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the Thoracic Surgery clinics.

You may qualify if:

• 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.

You may not qualify if:

• Inability to give informed consent
• Patients requiring a laryngectomy or colon interposition as part of their surgical resection.
• Patients with scleroderma.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Matthew Bott, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: March 14, 2012
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-04

Locations

US (1)