Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Acceptability of Study Procedures - Quantitative
研究概览
简要总结
The investigators developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes daily mood tracking, a psychoeducational module about cancer and depression, four components that are based on evidence-based interventions for depression. The goal of this study is to evaluate the acceptability of procedures for a future trial in which the investigators will test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs. Additionally, the investigators will evaluate study feasibility as well as intervention acceptability, satisfaction, usability, and engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39)
- •Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39)
- •Time since completion of treatment: 1 month to 5 years
- •Language: Fluent in English (spoken and written)
- •Technology: Own smart phone with data plan
排除标准
- •Mental Health: Current diagnosis of severe or persistent mental illness
- •Suicidality: Severe suicidal ideation (including plan and intent)
研究组 & 干预措施
Condition 1
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 2
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 3
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 4
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 5
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 6
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 7
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 8
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 9
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 10
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 11
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 12
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 13
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 14
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 15
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance)
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
Condition 16
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); and Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)
干预措施: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) (Behavioral)
结局指标
主要结局
Acceptability of Study Procedures - Quantitative
时间窗: Week 6
An investigator-developed survey will be used to evaluate acceptability of study procedures. Mean scale scores range from 1 to 4, with higher scores indicating greater acceptability. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.
Acceptability of Study Procedures - Qualitative
时间窗: Weeks 6-8
An investigator-developed semi-structured interview will be used to evaluate acceptability of study procedures. Transcriptions of semi-structured interviews will undergo rapid qualitative analysis to characterize the reasons for sub-optimal acceptability of study procedures.
次要结局
- Study Feasibility - Recruitment Rate(Upon enrollment of 16 participants)
- Intervention Acceptability - Quantitative(Week 6)
- Intervention Acceptability & Satisfaction - Qualitative(Weeks 6-8)
- eHealth Engagement Scale(Week 6)
- Intervention Adherence(Weeks 1-6)
- Study Feasibility - Retention Rate(Week 6)
- Intervention Satisfaction - Quantitative(Week 6)
- System Usability Scale(Week 6)
研究者
Karly M Murphy, PhD
Principal Investigator
East Carolina University