This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 28, 2004
Last updated: July 20, 2009
Last verified: November 2006

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
Cervical Cancer Psychosocial Effects of Cancer and Its Treatment Other: counseling intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Stress-Immune Response and Cervical Cancer

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Quality of life
  • Immune and neuroendocrine parameters
  • Correlation of psychosocial measures and immunologic stance

Estimated Enrollment: 50
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00086242     History of Changes
Other Study ID Numbers: CDR0000510143
Study First Received: June 28, 2004
Last Updated: July 20, 2009

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 processed this record on August 22, 2017