Stress-Immune Response and Cervical Cancer
Psychosocial Telephone Counseling (PTC)
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Other Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location