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

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

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Stress-Immune Response and Cervical Cancer

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 Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Active Control

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Cervical Cancer
Psychosocial Effects/Treatment

Intervention ^†

Procedure: counseling
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

Completion Date

Eligibility 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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00086242

Organization ID

CDR0000510143

Secondary IDs ^††

UCIRVINE-2003-3030

Study Sponsor ^†

Chao Family Comprehensive Cancer Center

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Lari B. Wenzel, PhD

Chao Family Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2006

First Received Date ^†

June 28, 2004

Last Updated Date

December 25, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.