Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease - Article
Clinical Trial: Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease
This study is no longer recruiting patients.
PURPOSE: Clinical trial to study the impact of therapy on the health status and quality of life of patients with stage I or stage II Hodgkin's disease who are receiving radiation therapy with or without chemotherapy.
|psychosocial effects/treatment |
stage II adult Hodgkin's disease
Quality of Life
stage I adult Hodgkin's disease
MedlinePlus related topics: Hodgkin's Disease
Study Type: Observational
Study Design: Longitudinal
Study start: April 1994
OBJECTIVES: I. Evaluate prospectively the health status and quality of life of patients with Stage I/IIA Hodgkin's disease randomized on protocol SWOG-9133 (CLB-9391) to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine.
III. Evaluate the intermediate and long-term effects of these treatments on these patients and compare their impact on quality-of-life outcomes over 5 years.
PROTOCOL OUTLINE: Quality-of-Life Assessment. Cancer Rehabilitation Evaluation System Short Form, CARES-SF; Symptom and Personal Information Questionnaire (including Symptom Distress Scale, MOS SF-36 Fatigue Scale, MOS SF-36 Health Perception Rating, Demographics); Cover Sheet.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued over 7 years.
Ages Eligible for Study: 18 Years and above
PROTOCOL ENTRY CRITERIA:
- Patients with Stage I/IIA Hodgkin's disease who are eligible for and registered on protocol SWOG-9133 (CLB-9391)
- Baseline quality-of-life assessment questionnaires must be completed prior to registration and randomization on SWOG-9133 (CLB-9391), including: Symptom and Personal Information Questionnaire; Cancer Rehabilitation Evaluation System Short Form; Cover Sheet
- Able to complete questionnaires in English
District of Columbia
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5000, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, 01655, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, 65203, United States
Beth Israel Medical Center, New York, New York, 10003, United States
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States
State University of New York - Upstate Medical University, Syracuse, New York, 13210, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem, North Carolina, 27157-1082, United States
Rhode Island Hospital, Providence, Rhode Island, 02903, United States
University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, 38163, United States
Charles A. Coltman, Jr., Study Chair, Southwest Oncology Group
Alice B. Kornblith, Study Chair
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002563
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005