Baptist Health System is participating in this Southwest Oncology Group (SWOG 9832) clinical trial, along with Y-ME, the breast cancer patient advocacy organization. The study began in 1998; Baptist has been participating since August 1999.

What is the objective of the study?

SWOG 9832 focuses on women who are experiencing a first recurrence of breast cancer, either local, regional, or distant. The study seeks to determine if the well-being of these patients is effected by telephone intervention delivered by counselors who are breast cancer survivors. Counselors are prepared to discuss physical matters, including those relating to symptoms and treatments; social matters, including how to understand the reactions of others and ways to build a social network; stress management, including relaxation techniques and exercise suggestions; and spiritual concerns.

This study seeks participation from 300 women nationwide, and will remain active until that participation level is attained. Participating women are randomized to either the control arm of the study, where they receive the standard level of support, or the intervention arm of the study, where they receive four to eight telephone counseling sessions from a trained Y-ME Hotline counselor. Each counselor has also received training from SWOG.

Women eligible for SWOG 9832 will have had previous surgical treatment for Stage I, II, or III breast cancer; will have been informed of their recurrence within the past 56 days; will be receiving their first treatment for the recurrence; and will read and understand English.

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After chemotherapy some people suffer from fatigue, lack of focus and concentration, inability to organize daily activities, and memory loss, a condition called Chemobrain. This condition can effect a patient's quality of life and get in the way of every day activities.

What is the objective of the study?

A research study is being conducted by The University of Texas Health Science Center at San Antonio and Cancer Therapy and Research Center to evaluate a potential treatment for chemobrain. The medication being studied is already approved for the treatment of ADHD (Attention Deficit Hyperactivity Disorder) in children, but is investigational in this use.

The study will last from nine to eleven weeks. Subjects will come for visits once a week, for ten weeks. During these visits they will be given questionnaires and assessments to evaluate the severity and improvement of their illness. The study is placebo-controlled, which means that some patients will receive an inactive pill and no drug. Subjects will be assigned to receive study drug or placebo randomly. Subjects have an equal chance of receiving the drug or the placebo. Subjects will be compensated for their time.

Subjects must have finished chemotherapy at least two months before enrolling in the study. They must have received at least four cycles of chemotherapy. Subjects cannot be currently receiving stringent, cytotoxic, anti-cancer therapies, including biological and/or radiation therapy. Subjects must be between the ages of 18 and 70 and speak English fluently.

For more information please contact one of the following:

• Donald R. Royall, M.D. 210-567-5494
• Martin Fuss, M.D. 210-616-5648
• Terence S. Herman, M.D. 210-616-5648
• Marsha Polk, Study Coordinator 210-838-6308

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