Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Changes in worry on the Penn State Worry Questionnaire
研究概览
简要总结
This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.
详细描述
PRIMARY OBJECTIVES:
I. To complete a randomized pilot trial of a cognitive-behavioral anxiety-insomnia intervention to determine the impact of this intervention on patient worry, intolerance of uncertainty, and sleep efficiency.
II. Explore the underlying endocrine and immune mechanisms responsible for a specific symptom cluster (anxiety-insomnia-depression-pain-fatigue) observed among advanced cancer patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Patients also receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5. Blood draw is optional.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lung cancer
- •stage III or IV colorectal cancer
- •pancreatic cancer
- •esophageal cancer
- •multiple myeloma
- •stage IIIC and IV melanoma
- •ovarian cancer
- •stage III & IV cervical cancer
- •stage III & IV uterine cancer
- •stage IIIB, IIIC, and IV breast cancer
- •glioblastoma multiforme
- •early relapse (< 1 year) lymphoma
排除标准
- •co-morbid immunologic disease (i.e. rheumatoid arthritis, systemic lupus)
- •neurologic disease (i.e. multiple sclerosis, Parkinson's, Alzheimer's) that would affect neuro-immune assessment or completion of study questionnaires
- •mania (if patient has bipolar disorder)
- •active substance abuse disorders such as alcohol dependence and cocaine abuse will also be excluded
结局指标
主要结局
Changes in worry on the Penn State Worry Questionnaire
时间窗: From baseline to 6 weeks
A linear mixed model will be used to evaluate the change from pre to post on the Penn State Worry Questionnaire. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcomes will be log transformed in order to meet these assumptions for the mixed models.
Changes in sleep efficiency on the Insomnia Severity Index
时间窗: From baseline to 6 weeks
A linear mixed model will be used to evaluate the change from pre to post on the Insomnia Severity Index. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then this outcome will be log transformed in order to meet these assumptions for the mixed models.
Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale
时间窗: From baseline to 6 weeks
A linear mixed model will be used to evaluate the change from pre to post on the Intolerance of Uncertainty Scale . The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcome will be log transformed in order to meet these assumptions for the mixed models.
次要结局
- Levels of cortisol(Baseline)
- Levels of pro and anti-inflammatory cytokines(Baseline)
- Levels of myeloid-derived suppressor cells (MDSC)(Baseline)
研究者
Sharla Wells-Di Gregorio
Principal Investigator
Ohio State University Comprehensive Cancer Center