Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or 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.

Inclusion criteria

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
• 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

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

Exclusion criteria

Disease Characteristics:

• Stage IV cervical carcinoma
• Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment
• Used investigational drugs within 30 days of execution of the informed consent
• Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection
• Patients with metastatic disease or ongoing treatment
• Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators

Patient Characteristics:

• Non-English or Spanish speakers