Clinical trial NCT00598117: Quality Of Life Outcomes Following Treatment for Esophageal Cancer
Official title: Quality Of Life Outcomes Following Treatment for Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: Esophageal
CancerEsophagus
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: To prospectively evaluate the quality of life of patients before and after esophageal cancer resection.
timeFrame: Initial assessment → first post op visit → 6 and 12 months post surgery
Secondary outcomes:
measure: 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.
timeFrame: 18 months following treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Manjit Bains, MD
role: PRINCIPAL_INVESTIGATOR
References: