NCT00086242

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

Stress-Immune Response and Cervical Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Cancer
• Psychosocial Effects of Cancer and Its Treatment

Interventions

Type	Name	Description
BEHAVIORAL	Psychosocial Telephone Counseling (PTC)	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.

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-12-31
• Completion: 2007-06-30
• First posted: 2004-06-29
• Last updated: 2019-03-08

Locations

1 site across 1 country: United States