Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 276
- 试验地点
- 5
- 主要终点
- Sleep disturbance (subjective)
研究概览
简要总结
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity, and gender) will be on stable CHC pharmacologic therapy (if any), self-identify as sleep disturbed (>5 on Pittsburgh Sleep Quality Index), do not have a sleep disorder diagnosis, do not take sleep medication/supplements >3 times per week, and are not currently practicing regular meditation.
Aim 1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary)) and secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy.
Aim 2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®).
Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) in CHC patients.
详细描述
Background:
Hematological cancers account for 11% of all cancer diagnoses in the US. Chronic hematological cancer (CHC) patients are characterized by long term and high symptom burden. Up to 65% of CHC patients report chronic sleep disturbances (e.g., difficulty falling asleep, difficulty staying asleep, nonrestorative sleep, insomnia) that are highly correlated with poorer cognitive and physical functioning, increases in fatigue and emotional distress, and heightened levels of specific inflammatory markers (TNF-a, IL-6, IL-8, CRP) that negatively impact quality of life. Sleep interventions have been tested in solid tumor patients, but no research has examined sleep interventions specifically for CHC patients. Medications are commonly prescribed but often come with side effects and risk for long-term dependence. Cognitive behavioral therapy for insomnia (CBT-I) is the most studied and first line of therapy for treating sleep disturbances in cancer patients, but CBT-I is time-consuming, resource-intensive, and not easily accessible for all cancer patients. There is a need for long-term, accessible, non-pharmacologic interventions targeting sleep in CHC patients.
RCTs have shown meditation and mindfulness-based interventions lead to improvements in sleep disturbance among breast cancer patients, but this research has not been extended to CHCs. Meditation has potential as a non-pharmacologic strategy to reduce sleep disturbance in CHC patients without the time and expertise limitations of CBT-I and side effect risks from medication. In person meditation, however, is still inaccessible long term due to potential fatigue, pain, transportation, and scheduling difficulties.
Smartphone apps have attracted considerable interest from cancer patients as an easily accessible and empowering way to self-manage health. Existing research using apps has focused on short term psychological measures (e.g., distress, cancer-related distress, anxiety, etc.) or cancer-specific biological changes as outcomes and not sleep disturbance, in solid tumor survivors with minimal residual disease (e.g., breast cancer post-treatment), or those with short survival (e.g., metastatic solid tumor patients). The unique, long-lasting disease course of CHC patients and high chronic symptom burden warrants distinct interventions from resolved solid tumor patients. CHC patients with sleep disturbance have no options for easily accessible and evidence-based treatments for sleep disturbances. The investigators propose to test the effects of two app-based wellness programs (10 minutes per day) on sleep disturbance in CHC patients.
Study Timeline:
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
- Double (Investigator, Outcomes Assessor)
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
- •Self-declared diagnosis of hematological cancer on stable maintenance management* by treating physician (i.e., on stable medical therapy) or observation (i.e., no changes in disease targeted medications for the past two weeks)
- •Not currently participating in a therapeutic pharmacologic clinical trial
- •Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks)
- •Score of >5 on PSQI (Pittsburgh Sleep Quality Index)
- •Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection
- •Willing to download two mobile apps
- •Able to read/understand English
- •≥18 years of age
- •Willing to be randomized
- •Willing to drive to a nearby lab for blood draws 3x during the study over the course of 20 weeks (8-week intervention period followed by 12-week follow-up period)
- •Taking sleep medications and/or over-the-counter sleep drugs/supplements (if any) on fewer than 3 nights per week and one of the following: 1) willing to maintain the same intake without change throughout the study time frame (i.e., 20 weeks) or 2) willing to discontinue if intake is prescribed "as needed" (PRN) by a physician throughout the study time frame (i.e., 20 weeks)
排除标准
- •Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months
- •Reside outside of the United States of America
- •Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes)
- •Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire)
- •Taking prescribed sleep medications and/or over-the-counter drugs/supplements (including drugs like NyQuil, Benadryl, and other antihistamine-based drugs) on ≥3 nights per week
- •Any other diagnosed and uncontrolled medical or psychiatric condition
- •Has a pacemaker
- •Shift work schedule
研究组 & 干预措施
Wellness app intervention #1
Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app.
干预措施: Wellness app intervention #1 (Behavioral)
Wellness app intervention #2
Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app.
干预措施: Wellness app intervention #2 (Behavioral)
结局指标
主要结局
Sleep disturbance (subjective)
时间窗: Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Sleep disturbance will be measured with an investigator-developed weekly sleep diary
Sleep disturbance (objective)
时间窗: Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Sleep disturbance will be measured with wrist actigraphy
Sleep Disturbance (subjective)
时间窗: Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep disturbance will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep Disturbance (subjective)
时间窗: Changes in sleep disturbance will be measured at baseline, week 2, week 4, week 6, week 8, and week 20. Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
Sleep disturbance will be measured with the Insomnia Severity Index (ISI). Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
次要结局
- Inflammation(Changes in inflammation will be measured at baseline, week 8, and week 20.)
- Fatigue (subjective)(Changes in fatigue will be measured at baseline, week 8, and week 20.)
- Anxiety (subjective)(Changes in anxiety will be measured at baseline, week 8, and week 20.)
- Depression (subjective)(Changes in fatigue will be measured at baseline, week 8, and week 20.)