REDEFINE AYAO: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 4
- 主要终点
- feasibility assessed through examination of response rate and study attrition variables
研究概览
简要总结
We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of health related quality of life, disease symptoms, and biological correlates of stress in a sample of young adults with cancer. The proposed work will serve as an essential foundation for launching a program of clinical stress reduction research with this traditionally underserved population and has the potential to lead to the discovery of specific, modifiable psychosocial, behavioral, and biological mechanisms from which to address the problem of health disparities with this group.
详细描述
Primary Objective Examine the feasibility and acceptability of MBSR with YACs. We hypothesize that MBSR will be feasible and acceptable with this population, which will be assessed through examination of response rate and study attrition variables.
Secondary Objectives
- Evaluate the effects of MBSR on outcomes of health related quality of life and disease symptoms among YACs.
- Explore the impact of different forms of eHealth maintenance support following the MBSR intervention (instructor-delivered, peer-delivered, no message) to help uphold intervention effects over time.
- Compare intervention and control groups on changes in biologic measures of stress (blood pressure, pulse, salivary cortisol, CRP and IL-6 biomarkers) over a 32-week period.
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
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of any cancer between ages 18-39
- •Must have signed and dated informed consent form, which includes agreeing to study procedures
- •Must be currently between 18-39 years of age
- •Must be able to read, write, speak and understand English
- •Must be able to perform basic activities of daily living
- •Must be cognitively intact and free of serious psychiatric illness
- •Must have the ability to use a touchscreen keypad on a tablet device
- •Must be willing to commit to either the MBSR course or waitlist control condition
- •Must be willing to commit to eHealth intervention maintenance conditions
- •Must be willing to complete all assessments
排除标准
- •Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
- •History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians
- •Regular user of mindfulness-based stress reduction or a similar mind-body therapy (e.g., yoga, meditation), which is defined as ≥ 3 times a week for the past 2 weeks
结局指标
主要结局
feasibility assessed through examination of response rate and study attrition variables
时间窗: week 33
feasibility assessed through examination of response rate and study attrition variables
次要结局
- compare between-group changes in biologic measures of stress accessed through biomarkers(baseline and study weeks 16 and 32)
- effects on health related quality of life accessed through online questionnaires(baseline and study weeks 8, 16, 24, and 32)
- the impact of eHealth maintenance support accessed through text message response(weekly, for the 8 consecutive weeks after the MBSR course)
研究者
David Victorson
Associate Professor of Medical Social Sciences
Northwestern University