NCT00002563

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 263 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lymphoma
• Psychosocial Effects of Cancer and Its Treatment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1994-04-01
• Primary completion: 2003-09-01
• Completion: 2005-05-01
• First posted: 2004-07-19
• Last updated: 2013-04-10

Locations

11 sites across 1 country: United States