Cervical Cancer Clinical Trial
Official title:
Stress-Immune Response and Cervical Cancer
RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being
and quality of life of patients who have cervical cancer. Changes in quality of life may be
related to changes in immune function and neuroendocrine function.
PURPOSE: This randomized phase I trial is studying how well telephone counseling works
compared to standard care in reducing stress in patients who have completed treatment for
stage I, stage II, or stage III cervical cancer.
OBJECTIVES:
- Compare quality of life (QOL) at baseline and changes in QOL, immune response, and
neuroendocrine parameters over time in patients who have completed treatment for stage
I-III cervical cancer receiving psychosocial telephone counseling vs usual care.
- Correlate psychosocial measures with immunologic stance.
OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to 1
of 2 intervention arms.
- Arm I: Patients undergo psychosocial telephone counseling comprising 5 weekly sessions
and a 1-month follow-up session to learn strategies for reducing stress.
- Arm II: Patients undergo usual care for approximately 4 months. All patients complete
questionnaires and Quality of life assessment at baseline and at 4 months. They also
undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune
studies.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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