Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stage I, Stage II, or Stage III Cervical Cancer - Full Text View

Sponsors and Collaborators:	Chao Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00086242

Purpose

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Cervical Cancer	Procedure: counseling Procedure: psychosocial assessment and care Procedure: quality-of-life assessment	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	Stress-Immune Response and Cervical Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Quality of life [ Designated as safety issue: No ]
Immune and neuroendocrine parameters [ Designated as safety issue: No ]
Correlation of psychosocial measures and immunologic stance [ Designated as safety issue: No ]

Estimated Enrollment:

50

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086242

Locations

United States, California
UCI, Health Policy and Research Center
Irvine, California, United States, 92697

Sponsors and Collaborators

Chao Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lari B. Wenzel, PhD

Chao Family Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000510143, UCIRVINE-2003-3030
Study First Received:	June 28, 2004
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00086242
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

psychosocial effects/treatment
stage IA cervical cancer
stage IB cervical cancer

stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer

Study placed in the following topic categories:

Stress

ClinicalTrials.gov processed this record on January 15, 2009