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Counseling And Guidance |
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Clinical Trial: Stress and the Immune Response in Women with Cervical Cancer
This study is currently recruiting patients.
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Purpose
The purpose of this study is to determine whether a telephone counseling intervention can enhance the quality of life for women with cervical cancer. This study will also determine whether reduced stress has an effect on hormonal and immune responses in these women.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Cervix Neoplasms | Behavior: Psychosocial Telephone Counseling | Phase I |
MedlinePlus related topics: Cervical Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control, Parallel Assignment, Efficacy Study
Official Title: Psychoneuroimmunology and Cervical Cancer
Expected Total Enrollment: 50
Cervical cancer patients often experience significant physical and emotional stress. Unfortunately, there is a lack of literature on stress treatments in this population. Mind-body interventions that include strategies to manage stress, enhance coping, and solve adjustment-related problems have demonstrated clear benefits in improving overall health. This study will examine the feasibility and benefits of a psychosocial telephone counseling (PTC) intervention and will determine whether long-term improvements in quality of life are associated with changes in neuroendocrine and immune parameters.
Participants in this study will be randomly assigned to receive 4 months of either PTC or usual care. PTC will consist of five weekly sessions and a 1-month follow-up session, during which participants will learn strategies for reducing stress. Neuroimmune and quality of life data will be collected at study start and at the end of the study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Stage I, II, or III cervical cancer for at 3 months and fewer than 15 months prior to enrollment
- Have completed treatment for cervical cancer
- Fluency in English or Spanish as a primary language
- Access to a telephone
Exclusion Criteria:
- Stage IV cervical cancer
- Previous treatment with a biological response modifier
- Prior immunotherapy within 4 weeks of study entry
- Use of investigational drugs within 30 days of study entry
- Use of corticosteroids or immune suppression therapy
- Metastatic disease or ongoing treatment
- Serious acute or chronic illnesses
Location and Contact Information
Robin Prado, BA 949-824-3570 prador@uci.edu
California
UCI, Health Policy and Research Center, Irvine, California, 92697, United States; Recruiting
Aysun Dogan-Ates, PhD 949-824-3384 aates@uci.edu
Lari B. Wenzel, PhD, Principal Investigator
Lari B. Wenzel, Principal Investigator, UCI, Health Policy and Research
More Information
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: June 28, 2004
ClinicalTrials.gov Identifier: NCT00086242
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Children and Divorce. (American Association for Marriage and Family Therapy)
- Counseling And Guidance (National Women's Health Information Center)

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