Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
This study generates information on the feasibility and acceptability of a 3-month ecological momentary assessment (EMA) protocol to assess chronic pain and opioid use in adolescent and young adult (AYA) sarcoma survivors.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of a 3-month EMA protocol in AYA sarcoma survivors.
II. Quantify variability in pain and opioid use over a 3-month period for AYA sarcoma survivors.
III. Identify associations between biopsychosocial mechanisms (e.g., pain beliefs, worry) and pain and opioid use outcomes.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All genders between the ages of 12-24 (inclusive) at sarcoma diagnosis.
- •Any age < 70 at the time of study enrollment.
- •No evidence of disease and/or enrolled in survivorship care.
- •Clinically meaningful pain related to disease or its treatments at baseline (defined as 3 or greater on a 0-10 Numerical Rating Scale).
- •Willing to attend the baseline appointment in person.
- •Access to internet-capable smartphone.
- •Access to internet on an occasional basis.
- •Willing and able to complete Ecological Momentary Assessments (EMAs) on internet-capable smartphone for a 3-month period after enrollment.
- •Ability to understand and provide informed consent/assent.
排除标准
- •* Currently receiving active cancer-directed therapy.
- •Unable to read or fluently speak English.
- •Determined by clinical staff to have preexisting or cancer-associated cognitive impairment that could interfere with study participation.
- •Acutely suicidal (e.g. intent or plan) or, with unstable medical or psychiatric condition verified by licensed study staff.
- •Characteristics related to inability to complete the study protocol.
结局指标
主要结局
Feasibility of recruitment
时间窗: Up to 12 months
Feasibility of recruitment will be based on number eligible per medical record
Feasibility of assessment
时间窗: Up to 12 months
will be indexed by number completing 80% of EMA assessments
Feasibility of recruitment
时间窗: up to 12 months
will be indexed by number attending baseline interview
Reasons for nonparticipation
时间窗: UP to 12 months
Semi structured qualitive interviews will focus on factors that influenced participation
Acceptability of EMA Study Design
时间窗: Up to 12 months
self-reported difficulty of participating in daily EMA surveys (0-19) .
Acceptability of EMA Design
时间窗: Up to 12 months
Acceptability of the protocol will be assessed by responses on the System Usability Scale - A 10 question scale from 1 to 5 with 1 being strongly disagree and 5 being strongly agree.
次要结局
未报告次要终点