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
- 2
- 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
研究组 & 干预措施
Pre-Intervention Qualitative Interviews
Qualitative interviews will be conducted with breast cancer survivors, survivors' caregivers, cancer support group leaders and clinicians regarding sleep disturbance in breast cancer survivors and preferences for an intervention for sleep disturbance.
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
干预措施: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference (Behavioral)
Waitlist control group
No intervention until 6 weeks after the baseline assessment, at which point participants complete a follow-up assessment and then are offered the new CBT-I intervention.
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)