Quality Of Life Outcomes Following Treatment for Esophageal Cancer

NCT00598117 | Completed

• 1 other identifier: 03-083
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Esophageal; CancerEsophagus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

Group 1 (newly diagnosed patients) Initial assessment → first post op visit → 6 and 12 months post surgery

Behavioral: Questionnaires

2

Group 2 (post-treatment patients) A one-time assessment will be conducted at least 18 months following treatment

Behavioral: Questionnaires

Interventions

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to give informed consent.
• Patients anticipated to require a laryngectomy as part of their surgical resection.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Manjit Bains, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: August 1, 2003
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

US (1)