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Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes (CXR01)

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ClinicalTrials.gov Identifier: NCT00496106
Recruitment Status : Unknown
Verified December 2010 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : July 4, 2007
Last Update Posted : December 16, 2010
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of California, Irvine

Brief Summary:

The purpose of the study is to:

  1. Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer survivors, compared to usual care.
  2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care.
  3. Examine the longitudinal relationship between PTC associated modulations of quality of life (QOL) measures and biologic parameters (immune and neuroendocrine).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Behavioral: Telephone counseling Behavioral: Telephone interview Phase 2

Detailed Description:

The incidence and mortality rates for invasive cervical cancer in minority, low-income, and less educated women exceeds that for white, higher income, and better educated women. In southern California the incidence and mortality rates for cervical cancer are nearly twice that of non-Latina white women. Our preliminary work supports and extends the extant literature, noting that quality of life can be significantly disrupted among cervical cancer survivors, with qualitative differences in how Latina women experience cancer survivorship. However, there is a paucity of literature on interventions designed to assist cervical cancer survivors manage illness-specific stress and improve health behaviors. Our current NIH-funded work suggests that a six session psychosocial telephone counseling (PTC) intervention can improve QOL and decrease psychological distress, with accompanying intervention-induced neuroendocrine and immune parameter modulations which may be related to disease endpoints. In primary support of these significant biobehavioral findings, the project herein proposes to accomplish the following Specific Aims:

  1. Test the efficacy of PTC for cervical cancer survivors, compared to usual care.
  2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care.
  3. Examine the longitudinal relationship between PTC associated modulations of QOL measures and biologic parameters (immune and neuroendocrine).

To achieve these aims the investigators will randomize patients ascertained through the two SEER cancer registries to PTC (N=125) or usual care (N=125), stratifying on English or Spanish language preference. Assessments will occur at baseline (9-20 months post diagnosis), and three and nine months post enrollment/baseline. Assessments will include evaluation of QOL (overall QOL, psychological distress, coping, social support, sexual functioning), health behaviors, neuroendocrine parameters dehydroepiandrosterone sulfate, growth hormone [DHEA-S, cortisol, GH] and immunologic parameters (natural killers [NK] cell activity, IL-5, interferon, human papillomavirus (HPV) E6/E7 peptides, IL-15, IL 10). This project has significant public health relevance for an important unstudied cancer survivor population, many of whom are poor and underserved. If effective, an intervention which could improve quality of life (QOL) and health behaviors, and enhance neuroendocrine and immune responses for women with cervical cancer could have significant implications toward disease recurrence or survival.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 939 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial
Study Start Date : August 2007
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Control Arm
6 telephone counseling sessions
Behavioral: Telephone counseling
6 telephone counseling sessions
Behavioral: Telephone interview
telephone interview
Active Comparator: Usual Care Arm
6 telephone counseling sessions
Behavioral: Telephone counseling
6 telephone counseling sessions
Behavioral: Telephone interview
telephone interview



Primary Outcome Measures :
  1. To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. To evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received the PTC intervention, compared to usual care [ Time Frame: 10 years ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cervical cancer (stage I, II, or III) patients who have completed definitive treatment at least 2 months earlier and who were diagnosed between 9 and 20 months prior to enrollment.

Exclusion Criteria:

  • Stage IV cervical cancer.
  • Have undergone previous treatment with biological response modifier or prior immunotherapy within 4 weeks of study enrollment.
  • Used investigational drugs within 30 days.
  • Were under immune suppression for any reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496106


Contacts
Contact: Lari Wenzel, PhD 949-824-3926 lwenzel@uci.edu

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Lari Wenzel    949-824-3926    lwenzel@uci.edu   
Sponsors and Collaborators
University of California, Irvine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Lari B Wenzel, PhD University of California, Irvine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lari Wenzel, MD, Chao Family Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00496106     History of Changes
Other Study ID Numbers: 2005-4526
R01CA118136-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: December 16, 2010
Last Verified: December 2010

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