Trial record 1 of 333 for:    cervical cancer University of California
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Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes (CXR01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00496106
First received: July 2, 2007
Last updated: December 15, 2010
Last verified: December 2010

July 2, 2007
December 15, 2010
August 2007
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00496106 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes
Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial

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).

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Ovarian Cancer
  • Behavioral: Telephone counseling
    6 telephone counseling sessions
  • Behavioral: Telephone interview
    telephone interview
  • Experimental: Control Arm
    6 telephone counseling sessions
    Interventions:
    • Behavioral: Telephone counseling
    • Behavioral: Telephone interview
  • Active Comparator: Usual Care Arm
    6 telephone counseling sessions
    Interventions:
    • Behavioral: Telephone counseling
    • Behavioral: Telephone interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
939
February 2011
August 2010   (final data collection date for primary outcome measure)

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.
Female
21 Years and older
No
Contact: Lari Wenzel, PhD 949-824-3926 lwenzel@uci.edu
United States
 
NCT00496106
2005-4526, R01 CA118136-01A1
No
Lari Wenzel, MD, Chao Family Comprehensive Cancer Center
University of California, Irvine
National Institutes of Health (NIH)
Principal Investigator: Lari B Wenzel, PhD University of California, Irvine
University of California, Irvine
December 2010

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