Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
研究概览
简要总结
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Located in the Southern Puerto Rico area
- •Able to speak and read Spanish
- •Have no documented or observable disabilities that would interfere with study participation
- •Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation)
- •Has clinically significant sleep disturbance (i.e., >/= 8 on the Insomnia Severity Index)
- •Is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy
- •Has access to the Internet and a digital device (e.g., smartphone) capable of using videoconference software
排除标准
- •Not able to read and speak Spanish
结局指标
主要结局
Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
时间窗: Baseline
The study will be deemed acceptable if ≥ 50% of eligible cancer survivors who are approached agree to participate. Recruitment rate will be measured by percentage of patients enrolled.
Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
时间窗: Approximately 6 weeks after first intervention session
The study will be deemed acceptable if \> 50% of intervention group participants report that, on average, they agree with positive statements about the intervention (i.e., report an average score of \>3 on a scale of 0 to 4).
Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances
时间窗: approximately 6 weeks after first intervention session
The study will be deemed feasible if ≥ 75% of the intervention group participants attend at least half of the educational components of the intervention. This will be operationalized as having attended at least half of the sessions.
次要结局
- Efficacy of New Intervention Using PSQI Scoring(Baseline and approximately 6 weeks after first intervention session)
- Efficacy of New Intervention Using ISI Scoring(Baseline and approximately 6 weeks after first intervention session)