Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stage I, Stage II, or Stage III Cervical Cancer
This trial is active, not recruiting.
|Conditions||cervical cancer, psychosocial effects of cancer and its treatment|
|Treatments||counseling intervention, psychosocial assessment and care, quality-of-life assessment|
|Sponsor||Chao Family Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Trial size||50 participants|
|Trial identifier||NCT00086242, CDR0000510143, UCIRVINE-2003-3030|
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.
Quality of life
Immune and neuroendocrine parameters
Correlation of psychosocial measures and immunologic stance
Female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Diagnosis of cervical cancer between the past 3-15 months - Stage I-III disease - Completed therapy for cervical cancer ≥ 1 month ago - Not receiving ongoing treatment PATIENT CHARACTERISTICS: - Resident of Orange, San Diego, or Imperial County in California - English or Spanish speaking - No serious acute or chronic illness - Has access to a telephone PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 4 weeks since prior immunotherapy - More than 30 days since prior investigational drugs - No prior biological response modifier - No concurrent corticosteroids - No concurrent immunosuppressive therapy
|Official title||Stress-Immune Response and Cervical Cancer|
|Principal investigator||Lari B. Wenzel, PhD|
|Description||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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