Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes

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.