Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stage I, Stage II, or Stage III Cervical Cancer
|ClinicalTrials.gov 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
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|
- 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|
|Official Title:||Stress-Immune Response and Cervical Cancer|
- Quality of life
- Immune and neuroendocrine parameters
- Correlation of psychosocial measures and immunologic stance
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086242
|United States, California|
|UCI, Health Policy and Research Center|
|Irvine, California, United States, 92697|
|Principal Investigator:||Lari B. Wenzel, PhD||Chao Family Comprehensive Cancer Center|