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Quality Of Life Outcomes Following Treatment for Esophageal Cancer

Quality Of Life Outcomes Following Treatment for Esophageal Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00598117
Enrollment
409
Registered
2008-01-18
Start date
2003-08-31
Completion date
2013-06-30
Last updated
2013-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Esophageal, CancerEsophagus

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.

Interventions

BEHAVIORALQuestionnaires

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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026