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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002563
• Other study ID #: CDR0000063515
• Secondary ID: U10CA032102SWOG-
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: April 8, 2013
• Start date: April 1994
• Est. completion date: May 2005

Study information

• Verified date: April 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: May 2005
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Psychosocial Effects of Cancer and Its Treatment

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee
United States	Beth Israel Medical Center	New York	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Oncology Group	Cancer and Leukemia Group B, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum in: J Clin Oncol. 2013 Jun 10;31(17):2231-2. — View Citation