Quality Of Life Outcomes Following Treatment for Esophageal Cancer
NCT ID: NCT00598117
Last Updated: 2013-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
409 participants
OBSERVATIONAL
2003-08-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Group 1 (newly diagnosed patients) Initial assessment → first post op visit → 6 and 12 months post surgery
Questionnaires
Newly diagnosed patients will be assessed at four points Time 1 (prior to treatment)
* Initial QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 2 (initial post-op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS Time 3 (6 months post op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 4 (1 year post op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS
2
Group 2 (post-treatment patients) A one-time assessment will be conducted at least 18 months following treatment
Questionnaires
Newly diagnosed patients will be assessed at four points Time 1 (prior to treatment)
* Initial QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 2 (initial post-op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS Time 3 (6 months post op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 4 (1 year post op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS
Interventions
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Questionnaires
Newly diagnosed patients will be assessed at four points Time 1 (prior to treatment)
* Initial QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 2 (initial post-op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS Time 3 (6 months post op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 4 (1 year post op)
* Follow up QOL form
* FACT-E, PAR, Symptom Assessment Scale, MDSS
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of esophageal cancer.
* Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, McKeown procedure) of esophageal cancer. (Group 1 patients only)
* Underwent esophagectomy for esophageal cancer at least 18 months prior to consent, with no evidence of disease. (Group 2 patients only)
* Ability to speak, read and write English.
Exclusion Criteria
* Patients anticipated to require a laryngectomy as part of their surgical resection.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Manjit Bains, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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03-083
Identifier Type: -
Identifier Source: org_study_id
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