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

Phase 2
21 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Lari B Wenzel, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine


United States: Institutional Review Board

Study ID:




Start Date:

August 2007

Completion Date:

February 2011

Related Keywords:

  • Ovarian Cancer
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms



University of California, Irvine Medical Center Orange, California  92868