Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Quality of Life Assessment of Patients Receiving Treatment for Esophageal Cancer

This study has been terminated.
(companion study to a study which closed administratively due to poor accrual)
Information provided by (Responsible Party):
Cancer and Leukemia Group B Identifier:
First received: November 1, 1999
Last updated: August 29, 2011
Last verified: August 2011

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.

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

Resource links provided by NLM:

Further study details as provided by Cancer and Leukemia Group B:

Enrollment: 0
Study Start Date: July 1998
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003381

  Show 44 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Study Chair: David G. Pfister, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Cancer and Leukemia Group B 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
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site processed this record on November 19, 2014