SWOG-9208 Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease

April 8, 2013 updated by: Southwest Oncology Group

Health Status and Quality of Life in Patients With Early Stage Hodgkin's Disease: A Companion Study to SWOG-9133

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- District of Columbia
  - Washington, District of Columbia, United States, 20307-5000
    - Walter Reed Army Medical Center
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University Of Iowa Hospitals And Clinics
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Memorial Medical Center
- Missouri
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Saint Louis, Missouri, United States, 63110
    - Barnes-Jewish Hospital
- New York
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - New York, New York, United States, 10003
    - Beth Israel Medical Center
  - Syracuse, New York, United States, 13210
    - State University of New York - Upstate Medical University
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157-1082
    - Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
- Tennessee
  - Memphis, Tennessee, United States, 38163
    - University of Tennessee, Memphis Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

DISEASE CHARACTERISTICS: Patients must be eligible for and registered to SWOG-9133

PATIENT CHARACTERISTICS: Patients must be able to complete the questionnaires in English. If they are not able to complete questionnaires in English, patients may be registered to SWOG-9133 without participating in SWOG-9208.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Investigators

Study Chair: Alice B. Kornblith, PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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. Erratum In: J Clin Oncol. 2013 Jun 10;31(17):2231-2.
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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1994

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000063515
U10CA032102 (U.S. NIH Grant/Contract)
SWOG-9208 (Other Identifier: SWOG)
CLB-9497 (Other Identifier: CALGB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.