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

Not Applicable

Completed

• Conditions: Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment
• Interventions: Behavioral: Psychosocial Telephone Counseling (PTC)

• Registration Number: NCT00086242
• Lead Sponsor: University of California, Irvine

Brief 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.

Study Timeline

• Study First Submitted: 2004-06-28
• Study First Submitted QC: 2004-06-28
• Study First Posted: 2004-06-29
• Study Start: 2004-08-01
• Primary Completion: 2005-12-31
• Study Completion: 2007-06-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychosocial Telephone Counseling (PTC)	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.

Primary Outcome Measures

Name	Time	Method
Change in quality of life measured by FACT-Cx	Baseline and 4 months after enrollment	FACT-Cx (Functional Assessment of Cancer Therapy-Cervical)
Change in neuroendocrine parameters	Baseline and 4 months after enrollment	Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios
Change in immune parameters	Baseline and 4 months after enrollment	Blood samples were tested for counterregulatory cytokine IL-10
Correlation of psychosocial measures and immunologic stance	Baseline and 4 months after enrollment	Spearman's correlation coefficient between the change in FACT-Cx and the change in Th1/Th2 Immune system bias

Trial Locations

Locations (1)

UCI, Health Policy and Research Center; 🇺🇸 Irvine, California, United States