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临床试验/NCT07220343
NCT07220343招募中不适用

Using Digital Phenotyping to Optimize Psychosocial Risk Screening and Personalized Care: a Pilot Study in Adolescents and Young Adults With Cancer

Stanford University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Change in Depressive Symptoms (Beck Depression Inventory - BDI)

研究概览

简要总结

The overall goal of the proposed study is to use digital phenotyping to identify and triage at-risk patients and accelerate access to critical mental health services.

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
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •10-25 years old
  • •Recent cancer diagnosis (>2 and <18 months since diagnosis)
  • •Willing to carry smartphone on their person for duration of study participation
  • •Willing to wear smartwatch for duration of study participation

排除标准

  • •Significant physical or mental disability that prevents completion of study activities
  • •Lack of proficiency in English or Spanish

研究组 & 干预措施

Digital Phenotyping Arm

Experimental

All participants (adolescents and young adults with cancer) will receive the digital phenotyping intervention, which includes wearing a smartwatch and using a smartphone-based EMA app over a 10-day period, with psychosocial assessments at baseline, day 10, and 2 months

干预措施: Device (Device)

Digital Phenotyping Arm

Experimental

All participants (adolescents and young adults with cancer) will receive the digital phenotyping intervention, which includes wearing a smartwatch and using a smartphone-based EMA app over a 10-day period, with psychosocial assessments at baseline, day 10, and 2 months

干预措施: Ecological Momentary Assessment (EMA) via My Personal Health Dashboard (MyPHD) Smartphone App (Behavioral)

结局指标

主要结局

Change in Depressive Symptoms (Beck Depression Inventory - BDI)

时间窗: Baseline, Day 10, 2 months

The Beck Depression Inventory-II (BDI-II; range 0-63) will be used to measure changes in depressive symptoms among adolescents and young adults over time. Higher scores indicate greater depressive symptom severity.

次要结局

  • Participant Retention Rate (MyPHD App and Wearable Device)(Baseline to 2 months)
  • Adherence to EMA Prompts(Baseline to 2 months)
  • Wearable Device Return and Use Rate(Baseline to 2 months)
  • Change in Anxiety Symptoms (Beck Anxiety Inventory - BAI)(Baseline, Day 10, 2 months)
  • Change in PTSD Symptoms (CROPS)(Baseline)
  • Change in PTSD Symptoms (PCL-5)(Baseline)
  • Change in Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)(Baseline, Day 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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