SWOG-9208 Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002563|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : April 10, 2013
RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment on patients with cancer.
PURPOSE: This clinical trial studies 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.
|Condition or disease||Intervention/treatment|
|Lymphoma Psychosocial Effects of Cancer and Its Treatment||Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
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. II. Describe the short-term effects of these treatments on these patients and compare their impact on quality of life (i.e., patient symptom status, health status, fatigue). 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.
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.
|Study Type :||Observational|
|Actual Enrollment :||263 participants|
|Official Title:||Health Status and Quality of Life in Patients With Early Stage Hodgkin's Disease: A Companion Study to SWOG-9133|
|Study Start Date :||April 1994|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||May 2005|
- Procedure: psychosocial assessment and care
Evaluate psychosocial function at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.
- Procedure: quality-of-life assessment
Evaluate quality of life at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002563
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5000|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Massachusetts|
|University of Massachusetts Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, Missouri|
|Ellis Fischel Cancer Center - Columbia|
|Columbia, Missouri, United States, 65203|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Beth Israel Medical Center|
|New York, New York, United States, 10003|
|State University of New York - Upstate Medical University|
|Syracuse, New York, United States, 13210|
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|United States, Tennessee|
|University of Tennessee, Memphis Cancer Center|
|Memphis, Tennessee, United States, 38163|
|Study Chair:||Patricia A. Ganz, MD||Jonsson Comprehensive Cancer Center|
|Study Chair:||Alice B. Kornblith, PhD||Dana-Farber Cancer Institute|