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Stress-Immune Response and Cervical Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Stress-Immune Response and Cervical Cancer


OBJECTIVES:

- Compare quality of life (QOL) at baseline and changes in QOL, immune response, and
neuroendocrine parameters over time in patients who have completed treatment for stage
I-III cervical cancer receiving psychosocial telephone counseling vs usual care.

- Correlate psychosocial measures with immunologic stance.

OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to
1 of 2 intervention arms.

- Arm I: Patients undergo psychosocial telephone counseling comprising 5 weekly sessions
and a 1-month follow-up session to learn strategies for reducing stress.

- Arm II: Patients undergo usual care for approximately 4 months. All patients complete
questionnaires and Quality of life assessment at baseline and at 4 months. They also
undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune
studies.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of cervical cancer between the past 3-15 months

- Stage I-III disease

- Completed therapy for cervical cancer ≥ 1 month ago

- Not receiving ongoing treatment

PATIENT CHARACTERISTICS:

- Resident of Orange, San Diego, or Imperial County in California

- English or Spanish speaking

- No serious acute or chronic illness

- Has access to a telephone

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since prior immunotherapy

- More than 30 days since prior investigational drugs

- No prior biological response modifier

- No concurrent corticosteroids

- No concurrent immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized

Outcome Measure:

Quality of life

Safety Issue:

No

Principal Investigator

Lari B. Wenzel, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000510143

NCT ID:

NCT00086242

Start Date:

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • psychosocial effects of cancer and its treatment
  • stage IA cervical cancer
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

UCI, Health Policy and Research CenterIrvine, California  92697