Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Bedroom Partners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Satisfaction assessed by study-specific survey after the intervention - acceptability
研究概览
简要总结
The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.
详细描述
Poor sleep is a common issue among cancer survivors that can persist for years and has been linked to increased symptoms (e.g., depression, fatigue), worse quality of life, and worse clinical outcomes like cancer progression and mortality. Partners of cancer survivors also experience poor sleep, but current interventions typically focus on survivors, leaving partners underrepresented. The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.
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
- 是
入选标准
- •Cancer Survivor eligibility criteria:
- •Inclusion Criteria:
- •Diagnosed with any cancer,
- •Completed curative treatment six months to five years before enrolling (excepting ongoing adjuvant endocrine therapy),
- •Score 8 to 14 on the Insomnia Severity Index (ISI)
- •Have a consistent bedroom partner (i.e., sleep in the same bedroom 4 or more nights per week).
- •Bedroom partner eligibility criteria:
- •1) No cancer within the past five years
- •Both survivors and bedroom partners:
- •Age > or =18 years,
- •Able to speak and read English,
- •Able to provide informed consent,
排除标准
- •No changes in type or dose of prescription sleep medications in the past three months,
- •Not engaged in behavioral sleep treatment for six months prior to enrollment,
- •Not planning to travel across 3 time zones or more during the eight intervention weeks or for the two weeks leading up to study assessments,
- •Not pregnant at enrollment or planning to become pregnant during the study,
- •No diagnosed or suspected psychiatric or medical condition that could interfere with participation,
- •No commitments that would interfere with regular night time sleep patterns (e.g., shift work),
- •No known untreated non-insomnia sleep disorders (e.g., sleep apnea, restless legs syndrome, hypersomnia, circadian rhythm sleep-wake disorder).
- •Enrolled participants will be allowed to remain in the study even if the other member of their dyad withdraws.
研究组 & 干预措施
Sleep coaching
Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app
干预措施: Sleep coaching (Behavioral)
Sleep education
Participants will receive electronic access to educational information about sleep for 8 weeks
干预措施: Sleep education (Behavioral)
结局指标
主要结局
Satisfaction assessed by study-specific survey after the intervention - acceptability
时间窗: 8 weeks - Immediately after the intervention
The intervention/study will be deemed acceptable if, on average, participants report satisfaction with the overall program/study as ≥2 on a 0-4 scale.
Feasibility assessed by recruitment and retention rates
时间窗: Throughout the recruitment period
The intervention/study will be deemed feasible if 50% of eligible potential participants enroll and 75% of enrolled participants are retained at post-intervention
次要结局
- Change in sleep health from baseline to immediately after the intervention(8 weeks - Immediately after the intervention)
- Change in insomnia symptoms from baseline to immediately after the intervention(8 weeks - Immediately after the intervention)
- Change in symptom burden from baseline to immediately after the intervention(8 weeks - Immediately after the intervention)