Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes

NCT ID: NCT00496106

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-02-28

Brief 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).

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:

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control Arm

6 telephone counseling sessions

Group Type: EXPERIMENTAL

Telephone counseling

Intervention Type: BEHAVIORAL

6 telephone counseling sessions

Telephone interview

Intervention Type: BEHAVIORAL

telephone interview

Usual Care Arm

6 telephone counseling sessions

Group Type: ACTIVE_COMPARATOR

Telephone counseling

Intervention Type: BEHAVIORAL

6 telephone counseling sessions

Telephone interview

Intervention Type: BEHAVIORAL

telephone interview

Interventions

Telephone counseling

6 telephone counseling sessions

Intervention Type: BEHAVIORAL

Telephone interview

telephone interview

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Lari Wenzel

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lari B Wenzel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

References

Wenzel L, Osann K, Hsieh S, Tucker JA, Monk BJ, Nelson EL. Psychosocial telephone counseling for survivors of cervical cancer: results of a randomized biobehavioral trial. J Clin Oncol. 2015 Apr 1;33(10):1171-9. doi: 10.1200/JCO.2014.57.4079. Epub 2015 Feb 23.

Reference Type: DERIVED

PMID: 25713429 (View on PubMed)

Other Identifiers

R01CA118136-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005-4526

Identifier Type: -

Identifier Source: org_study_id