Quality Of Life Outcomes Following Treatment for Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Quality Of Life Outcomes Following Treatment for Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598117
• Other study ID #: 03-083
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: June 26, 2013
• Start date: August 2003
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center