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临床试验/NCT07837089
NCT07837089尚未招募不适用

Development of a Peer Digital Coach Intervention to Increase Adolescent and Young Adult Cancer Survivors' Engagement With a Digital Behavioral Health Intervention

Hackensack Meridian Health1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2026年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
13
试验地点
1
主要终点
Minutes use per day (User engagement)

研究概览

简要总结

This is a phased mixed-methods behavioral intervention study that will develop and test Mindful Peer Coach, a peer-supported mindfulness program for adolescent and young adult (AYA) cancer survivors. Phase 1 is a formative qualitative study designed to identify survivor-reported needs and preferences for increasing engagement with a mindfulness meditation app. Phase 2 is a pilot intervention study that will examine the feasibility, acceptability, and preliminary engagement outcomes of the Mindful Peer Coach program using participant surveys, app-use data, peer-coach training, coaching sessions, weekly text-message check-ins, and exit interviews with survivors and coaches.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •at least one year from treatment completion
  • •ability to speak conversational English,
  • •per self-report, not being treated for posttraumatic stress disorder (PTSD), psychosis, or epilepsy/seizures.
  • •have experience with mindfulness and/or be willing to attend training and supervision sessions (only for coaches)
  • •at least two years from treatment completion (only for coaches) ;

排除标准

  • •outside age range
  • •closer to treatment completion than specified above

研究组 & 干预措施

Mindful Peer Coaching

Experimental

Mindful Peer Coach consists of 1) live virtual and 2) text message coaching.

干预措施: Live Virtual Coaching (Behavioral)

结局指标

主要结局

Minutes use per day (User engagement)

时间窗: Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase

Minutes use per day with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.

Number of days used per week (User engagement)

时间窗: Number of days used per week will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase.

Number of days used per week with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.

Depression

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Depression symptoms will be assessed using the PROMIS Depression measure. PROMIS Depression is an 8-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

Anxiety

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Anxiety symptoms will be assessed using the PROMIS Anxiety measure. PROMIS Anxiety is an 7-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.

Mindfulness

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Mindfulness will be assessed using the Mindful Attention Awareness Scale measure. Your score falls into a range of 1 to 6, calculated by taking the average of all 15 responses. Higher average scores indicate greater overall mindfulness.

Emotion Regulation

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Emotion Regulation will be assessed using the emotional experience subscale from the Emotion Regulation Questionnaire (ERQ) measure. The Emotion Regulation has 6 items on a 7-point Likert scale, with 1 indicating "strongly disagree" and 7 indicating "strongly agree" ranging from 6 to 42 (computed as the mean of the 6 items). Higher scores indicate a greater tendency to alter how you think about a situation to change its emotional impact.

Positive and Negative Emotions

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Positive and Negative Emotions will be assessed using I-PANAS-SF (International Positive and Negative Affect Schedule Short-Form). It is a 10-item psychological tool that assesses affect. It evaluates both Positive Affect and Negative Affect on two separate 5-item subscales. Each of the 10 emotions is rated on a 5-point Likert scale, resulting in score ranges of 5 to 25 for both the Positive and Negative subscales. Higher scores indicate higher levels of that specific effect.

Distress

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Distress will be assessed using the Perceived Stress Scale. The Perceived Stress Scale (PSS-10) is a 10 item scale that has a total score range from 0 to 40, with higher scores indicating higher levels of perceived stress.

Overall Wellbeing

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Overall Wellbeing will be assessed using the PROMIS Global Health scale. For the standard PROMIS Global Health (PROMIS-GH-10) assessment, the 10 items produce two distinct summary scales: Global Physical Health and Global Mental Health. Because both subscales are made up of 4 items measured on a 1-5 point scale, the raw score range for each subscale is 4 to 20. While raw scores are simply the sum of your responses, they are not used directly to interpret health status. Instead, raw scores are converted into standardized T-scores using an established lookup algorithm: A T-score of 50 represents the average health of the U.S. general population. Every 10 points away from 50 equates to one standard deviation. Higher T-scores indicate better self-reported health, regardless of whether it is the physical or mental subscale.

Sleep Disturbance

时间窗: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Sleep Disturbance will be assessed using the PROMIS Sleep Disturbance scale. The raw score range for the PROMIS Sleep Disturbance Scale 4-Item Short Forms: is generally 4 to 20. Higher raw scores correspond to a greater severity of sleep disturbance. These raw scores are then converted into a standardized T-score (where the general U.S. population average is 50, with a standard deviation of 10) using PROMIS Standardized Lookup Tables.

次要结局

  • Exit Interview(At the end of the 8-week intervention period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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