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.

Sponsors and Collaborators: National Cancer Institute (NCI)
Cancer and Leukemia Group B
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

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: 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.

Condition
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

Official Title: Companion Protocol to Evaluate Quality of Life and Health Status in Patients with Stage I/IIA Hodgkin's Disease Simultaneously Enrolled on SWOG-9133 or CLB-9391

Further Study Details: 

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.

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.

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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Population Characteristics--

  • 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

Location Information


District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States

Massachusetts
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States

Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States

      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States

New York
      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

North Carolina
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States

Tennessee
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38163,  United States

Study chairs or principal investigators

Charles A. Coltman, Jr.,  Study Chair,  Southwest Oncology Group   
Alice B. Kornblith,  Study Chair

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000063515; SWOG-9208
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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