Quality Of Life Outcomes Following Treatment for Esophageal Cancer
Study Details
Study Description
Brief Summary
The goal of this study is to evaluate how treatment for esophageal cancer affects your quality of life. The findings of this study may help us understand how this disease and its treatment affect your lifestyle, diet, exercise, support system and overall quality of life. We hope this study will provide important information that can be used to develop programs to improve the quality of life of patients with esophageal cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
In order to determine the impact of esophageal cancer and its treatment on patients' quality of life over time, this study will prospectively follow a cohort of patients at specified intervals, evaluating their physical symptoms, physical and social functioning and overall quality of life. Medical and sociodemographic factors as well as health behaviors that might be predictive of adaptation will be tested. This is a preliminary investigation and it is hoped that we will be able to base future research questions on the results of this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Group 1 (newly diagnosed patients) Initial assessment → first post op visit → 6 and 12 months post surgery |
Behavioral: 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 |
Behavioral: 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
|
Outcome Measures
Primary Outcome Measures
- To prospectively evaluate the quality of life of patients before and after esophageal cancer resection. [Initial assessment → first post op visit → 6 and 12 months post surgery]
Secondary Outcome Measures
- To describe a cohort of long term survivors of esophageal cancer in order to identify significant features in patients more than 18 months post surgery. [18 months following treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or older
-
Diagnosis of esophageal cancer.
-
Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, McKeown procedure) of esophageal cancer. (Group 1 patients only)
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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:
-
Inability to give informed consent.
-
Patients anticipated to require a laryngectomy as part of their surgical resection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Manjit Bains, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 03-083