Overview

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
Phase phase 1
Sponsor Chao Family Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Trial size 50 participants
Trial identifier NCT00086242, CDR0000510143, UCIRVINE-2003-3030

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized

Primary Outcomes

Measure
Quality of life
time frame:
Immune and neuroendocrine parameters
time frame:
Correlation of psychosocial measures and immunologic stance
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).