Stress-Immune Response and Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in neuroendocrine parameters
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Psychosocial Telephone Counseling (PTC)
Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies.
干预措施: Psychosocial Telephone Counseling (PTC) (Behavioral)
Usual Care
Eligible patients are randomized to receive either psychosocial telephone counseling (PTC) or usual care. The usual care are were only contacted by the study team to collect data in an identical frame to subjects receiving PTC.
结局指标
主要结局
Change in neuroendocrine parameters
时间窗: Baseline and 4 months after enrollment
Saliva samples were tested for cortisol
Change in immune parameters
时间窗: Baseline and 4 months after enrollment
Blood samples were tested for T helper type 1and 2 (Th1/Th2) bias, as measured by IFN-γ/interleukin-5 ELISpot T
Change in quality of life measured by FACT-Cx
时间窗: Baseline and 4 months after enrollment
FACT-Cx (Functional Assessment of Cancer Therapy-Cervical)
Correlation of psychosocial measures and immunologic stance
时间窗: Baseline and 4 months after enrollment
Spearman's correlation coefficient between the change in FACT-Cx and the change in Th1/Th2 Immune system bias
次要结局
未报告次要终点
研究者
Lari Wenzel
Professor
University of California, Irvine