Cervical Cancer Survivorship Among African-, European-, and Latina-American Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Utility of a psychosocial intervention in educating and improving awareness of the physical and psychological impact of cancer and in increasing knowledge about appropriate medical and psychosocial resources for cervical cancer survivors
研究概览
简要总结
RATIONALE: Telephone counseling may help reduce depression and anxiety and improve the well-being and quality of life of cervical cancer survivors.
PURPOSE: This randomized clinical trial is studying how well psychosocial support works in African-American, Latina-American, or European-American cervical cancer survivors.
详细描述
OBJECTIVES: I. To evaluate the utility of the 6 telephone sessions (low intensity: LiTx) and 8 telephone sessions (high intensity: HiTx) plus Survivorship Booklet designed to educate and improve awareness of the physical and psychological impact of cancer and increase knowledge of appropriate medical and psychosocial resources for women with cervical cancer. II. To evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve psychological functioning (decrease depression and anxiety) of women with cervical cancer. III. To evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve social functioning (family support and communication).
OUTLINE: Patients are clinically assigned to 1 of 2 groups. GROUP I: Patients receive a survivorship booklet in the mail that contains information about cervical cancer. Patients then receive a follow-up telephone call at 3 months to clarify any issues relevant to the survivorship booklet. GROUP II: Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Within 6 months to 3 years of a cervical cancer diagnosis Diagnosed with stages 1-3 invasive cervical cancer Not diagnosed with another type of cancer No other major disabling medical or psychiatric condition Survivors within 6 months to 3 years post diagnosis are included Participants must be able to read and/or speak either English or Spanish Women will not be excluded based on the type of treatment received for their cervical cancer or a history of diagnosis of mild depression or anxiety
排除标准
- •Women with metastatic disease Women with major medical conditions (e.g., stroke and degenerative illness) Survivors with moderate to severe depression or anxiety Asian participants Stage 0 disease
结局指标
主要结局
Utility of a psychosocial intervention in educating and improving awareness of the physical and psychological impact of cancer and in increasing knowledge about appropriate medical and psychosocial resources for cervical cancer survivors
时间窗: 12 months after study initiation
Utility of a psychosocial intervention in improving social functioning (i.e., family support and communication) among cervical cancer survivors
时间窗: 12 months after study initiation
Utility of a psychosocial intervention in improving psychological functioning (i.e., decreasing depression and anxiety) among cervical cancer survivors
时间窗: 12 months after study initiation
次要结局
未报告次要终点