Quality Of Life Outcomes Following Treatment for Esophageal Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00598117

Purpose

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	Intervention
Esophageal Cancer	Behavioral: Questionnaires

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Quality Of Life Outcomes Following Treatment for Esophageal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To prospectively evaluate the quality of life of patients before and after esophageal cancer resection. [ Time Frame: Initial assessment → first post op visit → 6 and 12 months post surgery ] [ Designated as safety issue: No ]

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. [ Time Frame: 18 months following treatment ] [ Designated as safety issue: No ]

Enrollment:	409
Study Start Date:	August 2003
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Groups/Cohorts

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

This is a descriptive study comprising two cohorts of esophageal cancer patients. The first cohort will be followed prospectively and will include patients newly diagnosed with esophageal cancer prior to treatment. QOL assessments will be administered pre-surgery, at first post-operative visit, and at 6 and 12 months post surgery. The second cohort will be a cross sectional sample and include patients more than 18 months post treatment, without evidence of disease who will undergo one QOL assessment. This is a preliminary investigation and it is hoped that we will be able to base future research questions on our results of this study.

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)
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598117

Locations

United States, New York
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

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00598117 History of Changes
Other Study ID Numbers:	03-083
Study First Received:	January 9, 2008
Last Updated:	November 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Esophageal
CancerEsophagus

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012