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 because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00086242
First received: June 28, 2004
Last updated: July 20, 2009
Last verified: November 2006
  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
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 [ 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
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 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
Investigators
Principal Investigator: Lari B. Wenzel, PhD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00086242     History of Changes
Other Study ID Numbers: CDR0000510143, UCIRVINE-2003-3030
Study First Received: June 28, 2004
Last Updated: July 20, 2009
Health Authority: United States: Federal Government

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
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 19, 2014