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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

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

June 28, 2004
July 20, 2009
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  • 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 ]
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Complete list of historical versions of study NCT00086242 on ClinicalTrials.gov Archive Site
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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
Stress-Immune Response and Cervical Cancer

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.

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.

Interventional
Phase 1
Allocation: Randomized
  • Cervical Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Other: counseling intervention
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00086242
CDR0000510143, UCIRVINE-2003-3030
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Chao Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Lari B. Wenzel, PhD Chao Family Comprehensive Cancer Center
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP