Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatments quality of life instruments, fact-e, symptom assessment scale, brief pain inventory and daily analgesic log
Sponsor Memorial Sloan Kettering Cancer Center
Start date March 2012
End date March 2017
Trial size 265 participants
Trial identifier NCT01558648, 12-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
quality of life instruments, fact-e, symptom assessment scale, brief pain inventory and daily analgesic log
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.
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.
quality of life instruments, fact-e, symptom assessment scale, brief pain inventory and daily analgesic log
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.

Primary Outcomes

Measure
short-term pain
time frame: 4 months
short -term quality of life (QOL)
time frame: 4 months

Secondary Outcomes

Measure
long-term pain
time frame: 2 years
long time quality of life (QOL)
time frame: 2 years
differences in surgical outcomes
time frame: 90 days
Complications
time frame: 90 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer
Principal investigator Matthew Bott, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.