Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Feasibility as measured by adherence
研究概览
简要总结
Women with breast cancer often experience multiple difficult symptoms, for example insomnia, fatigue, stress, and pain. This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Participants will complete six, 45-60 minute intervention sessions with a study therapist. Intervention sessions will be conducted remotely via conference (i.e., Zoom) or telephone. During these sessions, participants will learn mindfulness and cognitive-behavioral strategies to cope with nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Participants will be asked to complete three, brief (15-20 minute) surveys that will ask questions about their background, cancer diagnosis and treatments, cancer symptoms, and experience with the intervention. Participants will be compensated for completing all intervention sessions and surveys. Total study duration is about 12 weeks.
The greatest risk of this study is loss of confidentiality. Benefits from participating might include learning skills to reduce nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Information learned from this study may also benefit other patients with cancer in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •stage 0-IV breast cancer diagnosis within past 12 months
- •self-report >8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia
- •>18 years old
- •life expectancy of >12 months per medical chart or oncologist
- •Ability to speak and read English, and intact hearing and vision
排除标准
- •reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam <25;
- •serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy, severe or moderate untreated sleep apnea) indicated by self-report, medical chart, or oncologist/provider that would contraindicate safe participation;
- •engagement in behavioral insomnia (e.g., Cognitive-Behavioral Therapy for Insomnia) or symptom management (e.g., Pain Coping Skills Training) interventions within past 6 months
研究组 & 干预措施
Nite2Day
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Nite2Day)
The Nite2Day intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The Nite2Day intervention will consist of 6 weekly sessions that will between 45 and 60 minutes.
干预措施: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Behavioral)
结局指标
主要结局
Feasibility as measured by adherence
时间窗: 16 weeks (1-month post-intervention)
Adherence will be indicated by at least 75% of participants completing all study sessions and assessments
Feasibility as measured by study accrual
时间窗: 6 months of study recruitment
Treatment feasibility will be shown by meeting targeted study accrual (N = 15) in 6 months
Feasibility as measured by study attrition
时间窗: 12 weeks (post-intervention)
Treatment feasibility will be shown by no more than 25% study attrition
Change in insomnia symptoms
时间窗: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms.
Acceptability as measured by the 8-item Client Satisfaction Questionnaire (CSQ)
时间窗: 12 weeks (post-intervention)
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and summed to obtain an acceptability score ranging from 8 to 32, with higher scores indicating higher acceptability.
次要结局
- Change in fatigue symptoms(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Change in depressive symptoms(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Change in anxiety symptoms(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Change in pain severity(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Change in pain interference(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Change in mindfulness(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Change in self-efficacy for symptom management(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))