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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086242
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 29, 2004
Last Update Posted : July 21, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Psychosocial Effects of Cancer and Its Treatment Other: counseling intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Phase 1

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Official Title: Stress-Immune Response and Cervical Cancer

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Quality of life
  2. Immune and neuroendocrine parameters
  3. Correlation of psychosocial measures and immunologic stance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00086242

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)
Principal Investigator: Lari B. Wenzel, PhD Chao Family Comprehensive Cancer Center Identifier: NCT00086242     History of Changes
Other Study ID Numbers: CDR0000510143
First Posted: June 29, 2004    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: November 2006

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female