Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes (CXR01)
Recruitment status was Recruiting
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Purpose
The purpose of the study is to:
- Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer survivors, compared to usual care.
- Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care.
- 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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial |
- 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 ]
- 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 |
|---|---|
|
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
|
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:
- Test the efficacy of PTC for cervical cancer survivors, compared to usual care.
- Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care.
- 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| Contact: Lari Wenzel, PhD | 949-824-3926 | lwenzel@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
No publications provided
| Responsible Party: | Lari Wenzel, MD, Chao Family Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00496106 History of Changes |
| Other Study ID Numbers: | 2005-4526, R01 CA118136-01A1 |
| Study First Received: | July 2, 2007 |
| Last Updated: | December 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Ovarian Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Endocrine Gland Neoplasms Uterine Diseases Genital Diseases, Female Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on June 18, 2013