Adapted Telehealth Intervention for Insomnia Among Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility: Enrollment rate of those screened and eligible
研究概览
简要总结
This is a randomized pilot trial to test the feasibility and acceptability (primary outcomes) of a virtual cognitive behavioral program for insomnia for survivors of various cancer types. Secondary outcomes are to examine the preliminary effects on reducing insomnia severity from baseline to post-intervention.
详细描述
Cognitive Behavioral Therapy for insomnia (CBT-I), is an evidenced-based insomnia program that is recommended by the American College of Physicians and can be delivered using session-by-session treatment manuals.
Among cancer survivors, CBT-I has only yielded small-to-moderate sized improvements in several aspects of sleep, including sleep efficiency, sleep onset latency, and wake after sleep onset as compared with inactive control conditions. Moreover, systematic reviews of CBT-I with cancer survivors have found high rates of attrition and low attendance. Thus, while CBT-I for cancer survivors is promising, further adaptation is needed to demonstrate greater feasibility and larger effects. Additionally, CBT-I is traditionally delivered in-person, which is not feasible for many cancer survivors. Barriers include time limitations, travel, and illness burden constraints, as well as a paucity of trained CBT-I providers. Telehealth delivery of CBT-I is an innovative approach to address these barriers to care and enhance uptake.
The intervention being tested in this study was informed by a 4-10 session CBT-I protocol and adapted based on interviews the investigators conducted with cancer survivors with insomnia to learn about their sleep-related challenges, suggestions, and preferences for intervention delivery, as well as a systematic review and meta-analysis the investigators published in Sleep Medicine Reviews in 2020.
The research study procedures include screening for eligibility and randomization into 1 of 2 study arms: the Adapted Virtual Intervention Group or a Control Group (Enhanced Usual Care; referral for behavioral sleep medicine and sleep hygiene handout). Participants will be in this research study for approximately 2 months. It is expected that about 40 people will take part in this research study.
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
- •History of nonmetastatic, localized, or regional solid or blood malignancy(ies)
- •Completion of primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy)
- •Chronic insomnia
- •Age ≥18 years
排除标准
- •Self-reported inability to speak and write in English
- •Undertreated noninsomnia sleep disorder (e.g., sleep apnea)
- •Undertreated epilepsy, serious mental illness, or suicidality, and/or psychiatric hospitalization in the past year
- •Unwilling or unable to discontinue night shift work
结局指标
主要结局
Feasibility: Enrollment rate of those screened and eligible
时间窗: T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months
Percent of those screened and eligible who enroll (i.e., sign consent and complete baseline). Reasons for ineligibility, refusal, or drop out, will also be measured along with session attendance.
Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction
时间窗: T0 (Baseline)- T1 (Post-Intervention): 1 Month
Participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the program in exit interviews, which will use open-ended questions and response probes to explicate each rating.
次要结局
- Change in Insomnia Severity(T0 (Baseline)- T1(Post-Intervention): 1 Month)
研究者
Daniel Hall
Assistant Professor of Psychology
Massachusetts General Hospital