Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Acceptability of intervention
研究概览
简要总结
The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.
详细描述
Adolescents and Young Adults (AYAs) with cancer are at risk of distress, anxiety, depression, and poor quality of life. The use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested.
PRISM is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. Here, we propose to test a mobile health (mHealth) version of PRISM, mPRISM. In a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM using a waitlist control design.
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
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-25 years
- •Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)
- •Patient able to speak/read/write English or Spanish language
- •Cognitively able to participate in mHealth psychosocial intervention and interactive interviews
排除标准
- •Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
- •Patients with diagnosis of malignancy >12 months
- •Patients with relapsed, recurrent, or refractory disease
- •Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)
- •Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys
研究组 & 干预措施
mPRISM
The Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys.
干预措施: mPRISM (Behavioral)
Waitlist control
Usual Care (UC) available to both study arms consists of standard non-directed supportive care provided for all patients including an assigned social worker throughout cancer treatment. In a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys.
干预措施: mPRISM (Behavioral)
结局指标
主要结局
Acceptability of intervention
时间窗: immediately post-intervention
The Acceptability of Intervention Measure (AIM) is a well-validated 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Scale ranges from 4 to 20; higher scores are better.
Feasibility of intervention
时间窗: immediately post-intervention
The Feasibility of Intervention Measure (FIM) is a well-validated 4-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scale ranges from 4 to 20; higher scores are better.
Appropriateness of intervention
时间窗: immediately post-intervention
The Intervention Appropriateness Measure (IAM) is a well-validated 4-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Scale ranges from 4 to 20; higher scores are better.
次要结局
- Usability of intervention(immediately post-intervention)
- Change in anxiety and depression(immediately post-intervention, 3 months post-intervention)
- Change in distress(immediately post-intervention, 3 months post-intervention)
- Change in health-related quality of life(immediately post-intervention, 3 months post-intervention)
- Change in resilience(immediately post-intervention, 3 months post-intervention)
研究者
Nancy
Assistant Professor
Seattle Children's Hospital