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Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes (CXR01)
This study is currently recruiting participants.
Verified by University of California, Irvine, October 2009
First Received: July 2, 2007   Last Updated: October 14, 2009   History of Changes
Sponsor: University of California, Irvine
Collaborator: National Institutes of Health (NIH)
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00496106
  Purpose

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 Intervention Phase
Ovarian Cancer
Behavioral: Telephone counseling
Behavioral: Telephone interview
Phase II

Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 939
Study Start Date: August 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control Arm: Experimental
6 telephone counseling sessions
Behavioral: Telephone counseling
6 telephone counseling sessions
Behavioral: Telephone interview
telephone interview
Usual Care Arm: Active Comparator
6 telephone counseling sessions
Behavioral: Telephone counseling
6 telephone counseling sessions
Behavioral: Telephone interview
telephone interview

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 we 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496106

Contacts
Contact: Leola McClure, PhD 949-824-3384 tmcclure@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
Investigators
Principal Investigator: Lari B Wenzel, PhD University of California, Irvine
  More Information

No publications provided

Responsible Party: Chao Family Comprehensive Cancer Center ( Lari Wenzel, MD )
Study ID Numbers: 2005-4526, R01 CA118136-01A1
Study First Received: July 2, 2007
Last Updated: October 14, 2009
ClinicalTrials.gov Identifier: NCT00496106     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms by Site
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine Gland Neoplasms
Neoplasms
Urogenital Neoplasms
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on November 30, 2009