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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Stress-Immune Response and Cervical Cancer

Conditions
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Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Behavioral: Psychosocial Telephone Counseling (PTC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial Telephone Counseling (PTC)<br>Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions,  45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies. | Behavioral: Psychosocial Telephone Counseling (PTC)<br>* Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions,  45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies.<br>|
| No Intervention: Usual Care<br>Eligible patients are randomized to receive either psychosocial telephone counseling (PTC) or usual care. The usual care are were only contacted by the study team to collect data in an identical frame to subjects receiving PTC. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life measured by FACT-Cx | FACT-Cx (Functional Assessment of Cancer Therapy-Cervical) | Baseline and 4 months after enrollment | 
| Change in neuroendocrine parameters | Saliva samples were tested for cortisol | Baseline and 4 months after enrollment | 
| Change in neuroendocrine parameters | Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios | Baseline and 4 months after enrollment | 
| Change in immune parameters | Blood samples were tested for T helper type 1and 2 (Th1/Th2) bias, as measured by IFN-γ/interleukin-5 ELISpot T | Baseline and 4 months after enrollment | 
| Change in immune parameters | Blood samples were tested for counterregulatory cytokine IL-10 | Baseline and 4 months after enrollment | 
| Correlation of psychosocial measures and immunologic stance | Spearman's correlation coefficient between the change in FACT-Cx and the change in Th1/Th2 Immune system bias | Baseline and 4 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer