Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes

Ovarian Cancer Clinical Trial

— CXR01  

Official title:

Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496106
• Other study ID #: 2005-4526
• Secondary ID: R01CA118136-01A1
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: February 2011

Study information

• Verified date: March 2019
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: February 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Telephone counseling
6 telephone counseling sessions
• Telephone interview
telephone interview

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care		10 years
Secondary	To evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received the PTC intervention, compared to usual care		10 years