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| Study 1 of 52 for search of: | cervical cancer University of California |
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| 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:
| 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 |
| 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
|
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:
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Leola McClure, PhD | 949-824-3384 | tmcclure@uci.edu |
| United States, California | |
| University of California, Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Lari Wenzel 949-824-3926 lwenzel@uci.edu | |
| Principal Investigator: | Lari B Wenzel, PhD | University of California, Irvine |
More Information
| 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 |
|
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 |