Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes
Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes
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.
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.