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临床试验/NCT03564587
NCT03564587已完成不适用

Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial

Emory University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Change in the he Children's Hope Scale score

研究概览

简要总结

A behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. The goals of this project are to adapt the AWAKE platform into an intervention acceptable for use in adolescent cancer survivors and their guardians in order to improve survivors' hope, quality of life, and health-promoting behaviors, and to generate the preliminary data needed for a randomized control trial to test the efficacy of the AWAKE platform in this population.

详细描述

A behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. Adaptation of this intervention to incorporate messaging for adolescents and their guardians has the potential to have a long-term impact on adolescent cancer survivors. The goals of this project are to adapt the AWAKE platform into an intervention acceptable for use in adolescent cancer survivors and their guardians in order to improve survivors' hope, quality of life, and health-promoting behaviors, and to generate the preliminary data needed for a randomized control trial to test the efficacy of the AWAKE platform in this population.

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
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Adolescent survivors:
  • •Early survivor: 3 months to 2 years after therapy completion
  • •Long-term survivor: ≥2 years after therapy completion
  • •13-17 years of age
  • •Access to tablet or smartphone and internet
  • •One designated guardian per survivor

排除标准

  • •Cognitive delay that would preclude participation
  • •Participant or designated guardian unable to read English
  • •Active disease relapse

研究组 & 干预措施

AWAKE

Experimental

The AWAKE intervention is an 8 week program including a mobile app and phone-based coaching, focused on improving hope in order to increase quality of life and health-promoting behaviors in young adult cancer survivors.

干预措施: AWAKE (Behavioral)

No treatment

No Intervention

Control participants will receive the surveys to complete only; however, they may opt to receive the intervention after the 4-month assessment.

结局指标

主要结局

Change in the he Children's Hope Scale score

时间窗: Baseline, 2 and 4 months follow up visits

A 6-item self-report questionnaire assessing children's dispositional hope. Two components, agency (ability to initiate and sustain action towards goals) and pathways (capacity to find a means to carry out goals), are assessed by the measure. Responses are on a 6-point Likert-scale ranging from 1=none of the time to 6=all of the time with higher scores representing increased dispositional hope.

次要结局

  • Change in number of physical activity hours per day(Baseline, 2 and 4 months follow up visits)
  • Change in the Pediatric Quality of Life Inventory (PedsQL), 4.0 scale score(Baseline, 2 and 4 months follow up visits)
  • Change in number of servings of fruits and vegetables(Baseline, 2 and 4 months follow up visits)
  • Change in number of screen time hours per day(Baseline, 2 and 4 months follow up visits)
  • Change in PROMIS score(Baseline, 2 and 4 months follow up visits)
  • Usability of AWAKE(2 month assessment)
  • Satisfaction with AWAKE(2 month assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Effinger

Assistant Professor

Emory University

研究点 (1)

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