Clinical trial NCT00086242: Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
Official title: Stress-Immune Response and Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: 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
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-29
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function.

PURPOSE: This randomized phase I trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage I, stage II, or stage III cervical cancer.

Detailed description: 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.

Eligibility criteria: 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
* 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

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

EXCLUSION CRITERIA

Disease Characteristics:

* Stage IV cervical carcinoma
* Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment
* Used investigational drugs within 30 days of execution of the informed consent
* Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection
* Patients with metastatic disease or ongoing treatment
* Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators

Patient Characteristics:

* Non-English or Spanish speakers

Primary outcomes:
measure: Change in quality of life measured by FACT-Cx
timeFrame: Baseline and 4 months after enrollment
measure: Change in neuroendocrine parameters
timeFrame: Baseline and 4 months after enrollment
measure: Change in neuroendocrine parameters
timeFrame: Baseline and 4 months after enrollment
measure: Change in immune parameters
timeFrame: Baseline and 4 months after enrollment
measure: Change in immune parameters
timeFrame: Baseline and 4 months after enrollment
measure: Correlation of psychosocial measures and immunologic stance
timeFrame: Baseline and 4 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI, Health Policy and Research Center
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Lari B. Wenzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: