Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intervention feasibility.
研究概览
简要总结
This study will explore feasibility and acceptability of using a daily mobile mindfulness app to cope with stress. In addition, feasibility of digital health data collection procedures including wrist-worn devices and ecological momentary assessments will be examined.
PRIMARY OBJECTIVES
- Determine the feasibility and acceptability of completing the 30-day mobile mindfulness program
- Evaluate the feasibility of digital health data collection procedures to detect autonomic nervous system (ANS) activation associated with stress (e.g., electrodermal activity, pulse rate variability, skin temperature) via wearable devices and self-reported ecological momentary assessments (EMA) among adult survivors of childhood cancer in the SJLIFE cohort
- Generate preliminary data to estimate the effect size and power needed for an extramurally funded randomized controlled trials (RCT) examining the impact of daily mindfulness mediation on biomarkers of ANS activation, coping, health behaviors, and cardiometabolic outcomes in a cohort of survivors of childhood cancer.
详细描述
Prior to engaging in the intervention participants will complete baseline assessments of stress and coping. Participants will then engage in a daily mindfulness practice via the Headspace mobile application. The basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control. During the first and fourth week of the intervention, participants will complete EMAs assessing mood, current activity, and intervention engagement. Participants will also wear a wrist-worn device to assess biomarkers of stress. At the completion of the intervention participants will complete follow-up assessments related to intervention and data collection procedures feasibility and acceptability as well as coping behaviors and stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Research participant is at least 18 years old at enrollment
- •Research participant is followed by St. Jude Children's Research Hospital (SJCRH)
- •Research participant has a diagnosis history of leukemia or lymphoma
- •Research participant takes part in the St. Jude Lifetime Cohort Study (SJLIFE)
- •Research participant has elevated psychological stress scores of 6 or greater on most recent SJLIFE questionnaire
- •Participant can speak and read English
排除标准
- •Research participant currently engages in mindful stress-reduction practices >2x per week (e.g., tai chi, meditation)
- •Research participant takes psychiatric medications or medications that impact cardiac functioning, beta-blockers, alpha-blockers
- •Research participant wears a pacemaker
- •Research participant has a diagnosis of a congenital heart disease
- •Research participant has no access to a smartphone
- •Research participant has elevated pain interference scores (T≥70)
研究组 & 干预措施
Single-arm, Within-subject Feasibility Pilot:
Single-arm, within-subject feasibility pilot: Participants completed a 30-day app-based mindfulness intervention with wearable biosensor monitoring, ecological momentary assessment, surveys, and blood specimen collection.
干预措施: Headspace (Device)
结局指标
主要结局
Intervention feasibility.
时间窗: 30 days (during intervention
Headspace provides user metrics including date/time of meditation sessions, number of sessions completed, average duration of each session, and total meditation minutes overall.
Intervention acceptability
时间窗: up to 1 week post intervention]
Treatment Acceptability and Adherence Scale- Participants will rate on a 0 ("Strongly disagree") to 7 ("Strongly agree") scale regarding their perceptions of acceptability of the mindfulness intervention (10 items).
Data collection feasibility.
时间窗: up to 1 week post intervention
Wearable Technology. EmbracePlus includes on-wrist detection, and this data will be used to evaluate how long and for how many days participants wear the device. EMA. Completion of EMA data will be calculated based on the number of assessments completed
EMA data collection acceptability
时间窗: up to 1 week post intervention
An adapted version of the TAAS was created to evaluate EMA assessment acceptability (7 items). Higher scores are indicative of greater acceptability
Mindfulness App Adherence
时间窗: 30 days (during intervention)
Mindfulness app adherence was defined as the proportion of participants who completed at least 4 meditation sessions on average during the 30-day intervention.
Intervention Acceptability
时间窗: Up to 1 week post intervention
Treatment Acceptability and Adherence Scale - Participants will rate on a 0 ("Strongly disagree") to 7 ("Strongly agree") scale regarding their perceptions of acceptability of the mindfulness intervention (10 items). Scores range from 0-70. An overall score is provided with higher scores indicating higher intervention acceptability.
Ecological Momentary Assessment Data Collection Acceptability
时间窗: Up to 1 week post intervention
An adapted version of the Treatment Acceptability and Adherence Scale was created to evaluate ecological momentary assessment acceptability (7 items). Scores range from 0-49. An overall score is provided with higher scores indicating higher intervention acceptability.
Biosensor (Wrist-worn Device) Adherence
时间窗: Approximately 37 days over the study window (7-day baseline washout plus 30-day intervention)
Biosensor adherence was defined as the proportion of participants who wore the wrist-worn biosensor for at least 10 hours per day across the approximately 37-day study window.
次要结局
- Brief Cope inventory is a 28-item, validated assessment measure of positive and negative coping strategies across 14 domains. Participants respond on a 4 point Likert scale how often they have engaged in a particular coping strategy(Baseline and up to 1 week post intervention)
- Perceived Stress Scale(Baseline and up to 1 week post intervention)
- Brief Coping Orientation to Problems Experienced (COPE)(Baseline and up to 1 week post intervention)
- Oxidized Low-Density Lipoprotein(Baseline and up to 1 week post intervention)
- Pro-B-type Natriuretic Peptide(Baseline and up to 1 week post intervention)
- P-selectin(Baseline and up to 1 week post intervention)
- Vascular Cell Adhesion Molecule-1(Baseline and up to 1 week post intervention)
- Homocysteine(Baseline and up to 1 week post intervention)
- High-sensitivity C-Reactive Protein(Baseline and up to 1 week post intervention)