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临床试验/NCT06732375
NCT06732375招募中不适用

Pilot Study of Mindset Moments Among Adolescent and Young Adult Cancer Survivors

Duke University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月13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
发起方
入组人数
40
试验地点
1
主要终点
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

研究概览

简要总结

The purpose of this study is to evaluate the feasibility and acceptability of the Mindset Moments™ (MM™) program in managing psychological distress and resiliency in adolescent and young adult cancer survivors.

Study participation will involve attending 8 weekly, one hour, live online group sessions and completing daily 5 minute activities such as guided imageries and CBT check in within the app. Participants will also be asked to complete an online survey at the time of enrollment and at 4 and 8 weeks.

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
19 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •19-25 years of age
  • •Prior AYA cancer diagnosis
  • •Completed primary treatment for their cancer
  • •Score of 3 or above on the Distress Thermometer at the time of recruitment

排除标准

  • •Individuals without legal capacity to give consent
  • •Individuals who are not fluent in reading, writing, and speaking English

研究组 & 干预措施

Interventional arm

Experimental

Study participation will involve attending 8 weekly, one hour, live online group sessions and completing daily 5 minute activities such as guided imageries and CBT (cognitive behavioral therapy) check-in within the app.

干预措施: Mindset Moments (Behavioral)

结局指标

主要结局

Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

时间窗: 8 weeks

8-measure short form to assess the severity of anxiety symptoms within the Patient-Reported Outcomes Measurement Information System (PROMIS) framework. The total score ranges from 8 to 40, where a higher score indicates greater anxiety.

次要结局

  • Distress as measured by the National Comprehensive Cancer Network's (NCCN) Distress Thermometer (DT)(8 weeks)
  • Ability to deal with stressful situations as measured by the Shift-and-Persist Scale(8 weeks)
  • Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)(8 weeks)
  • Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the PCL-5(8 weeks)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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