Quality of Life Assessment of Patients Receiving Treatment for Esophageal Cancer
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Purpose
RATIONALE: Questionnaires that measure quality of life during treatment may improve the ability to plan treatment for patients with esophageal cancer.
PURPOSE: This clinical trial is studying the quality of life in patients receiving treatment for esophageal cancer.
| Condition |
|---|
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Psychosocial Effects of Cancer and Its Treatment |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Quality of Life and Cost Analysis of a Prospective Randomized Phase III Trial Comparing Trimodality Therapy to Surgery Alone for Esophageal Cancer |
| Enrollment: | 0 |
| Study Start Date: | July 1998 |
OBJECTIVES: I. Evaluate the quality of life of patients with esophageal cancer randomized on protocol CALGB C9781 to treatment with surgery alone vs trimodal therapy combining preoperative chemotherapy and radiation therapy in addition to surgery. II. Examine the incremental cost and cost effectiveness of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer. III. Examine the incremental cost per quality-adjusted life year (QALY) of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer.
OUTLINE: This is a companion study to CALGB C9781, a phase III randomized study. Prior to treatment on CALGB C9781, patients complete forms assessing quality of life, psychological functioning, specific areas of dysfunction, resource use, and time lost from work; subsequent assessments are completed by telephone interview at 1, 2, 6, 12, 18, and 24 months after the initiation of study treatment, regardless of disease status (patients with hearing impairment and those speaking only a translatable foreign language may mail responses). Patients also keep a diary of medical resource utilization at sites other than the treating institution.
PROJECTED ACCRUAL: Approximately 180 patients will be accrued to this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients on clinical trial
DISEASE CHARACTERISTICS: Patients with esophageal cancer enrolled on protocol CALGB-C9781
PATIENT CHARACTERISTICS: Age: 18 and over Patient able to communicate in English or Spanish
Contacts and Locations
Show 44 Study Locations| Study Chair: | David G. Pfister, MD | Memorial Sloan-Kettering Cancer Center |
More Information
No publications provided
| Responsible Party: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00003381 History of Changes |
| Other Study ID Numbers: | CDR0000066376, CLB-9870 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 29, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
psychosocial effects of cancer and its treatment |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013