SWOG-9208 Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease
NCT ID: NCT00002563
Last Updated: 2013-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
263 participants
OBSERVATIONAL
1994-04-30
2005-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
The Symptom and Personal Information Questionnaire #1, the Cancer Rehabilitation Evaluation System Short Form (CARES-SF) and Cover Sheet must be completed prior to registration and randomization on SWOG-9133.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cancer and Leukemia Group B
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Patricia A. Ganz, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Alice B. Kornblith, PhD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Beth Israel Medical Center
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Countries
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References
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Ganz PA, Moinpour CM, McCoy S, et al.: Predictors of vitality (energy/fatigue) in early stage Hodgkin's disease (HD): results from Southwest Oncology Group (SWOG) study 9133. [Abstract] J Clin Oncol 22 (Suppl 14): A-6546, 569s, 2004.
Ganz PA, Moinpour CM, Pauler DK, Kornblith AB, Gaynor ER, Balcerzak SP, Gatti GS, Erba HP, McCoy S, Press OW, Fisher RI. Health status and quality of life in patients with early-stage Hodgkin's disease treated on Southwest Oncology Group Study 9133. J Clin Oncol. 2003 Sep 15;21(18):3512-9. doi: 10.1200/JCO.2003.01.044.
Moinpour CM, Unger JM, Ganz PA, Kornblith AB, Gaynor ER, Bowers MA, Gatti GS, Kaminski MS, Erba HP, Wang T, Yoon J, Press OW, Fisher RI. Seven-year follow-up for energy/vitality outcomes in early stage Hodgkin's disease patients treated with subtotal lymphoid irradiation versus chemotherapy plus radiation: SWOG S9133 and its QOL companion study, S9208. J Cancer Surviv. 2017 Feb;11(1):32-40. doi: 10.1007/s11764-016-0559-y. Epub 2016 Jul 12.
Other Identifiers
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SWOG-9208
Identifier Type: OTHER
Identifier Source: secondary_id
CLB-9497
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000063515
Identifier Type: -
Identifier Source: org_study_id
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