Quality Of Life Outcomes Following Treatment for Esophageal Cancer

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaires

Behavioral

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

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2003
Primary completion: 2013
Study completion: 2013
First posted: Jan 18, 2008
Registry last updated: Jun 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed