Building mHealth Parent Capacity to Manage Pain in Young Children With Cancer: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility - attrition
研究概览
简要总结
Pain is a problem for children with cancer, especially when they are outside of the hospital setting. Younger children with cancer are particularly vulnerable to undermanaged pain because of their inability to self-report pain and their reliance on parents for treatment. One method to help these children to get the best care possible is through the use of smartphone-based mHealth solutions. Smartphone apps can provide treatment advice to patients experiencing pain in real-time and in any environment. This research will use a phased and user-centered approach with family caregivers to co-design and co-evaluate the new cancer Pain Caregiver Resource (PainCaRe) app to achieve the following aims: (1) high-fidelity software development and usability refinement; (2) evaluation of trial feasibility and preliminary effectiveness in a pilot randomized controlled trial (RCT); and (3) systematic analysis of caregiver app usage patterns to refine PainCaRe for optimal engagement prior to a future RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be the primary caregiver, or person assuming the majority of care activities, for a child aged 2-11 years undergoing cancer treatment and experiencing above mild pain (≥3/10) in the week preceding study enrolment (pain measured by self or caregiver proxy using a validated numerical 11-point rating scale).
- •Be able to speak and read English.
排除标准
- 未提供
研究组 & 干预措施
Intervention Arm
Participants will download the PainCaRe app from the web to their personal phone either virtually or in-person. Parents will receive app-based notifications to complete a pain assessment report once-daily. Assessments not completed will be marked as "missed". Parents will also have the ability to complete ad hoc pain assessments as needed.
In response to the assessment indicating a child has pain, evidence-based, algorithm-driven pharmacological, physical, or psychological pain treatment guidance will be provided. This guidance is tailored to the age and developmental stage of the child.
干预措施: Pain Caregiver Resource (PainCaRe) (Other)
Control Arm
Parents randomized to the control arm (non-intervention group) will not be assigned to the PainCaRe app and their child will continue to receive standard medical and pain care.
结局指标
主要结局
Feasibility - attrition
时间窗: 1 year
Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition \<25%.
Feasibility - accrual
时间窗: 1 year
Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual \>60%.
Feasibility - adherence
时间窗: 8 weeks
Adherence to the intervention will be measured using the Analytics Platform to Evaluate Effective Engagement (APEEE) platform, a proprietary analytics software measuring the number of once-daily pain assessments completed and engagement with pain treatment guidance. Criteria for feasibility: adherence to twice-daily pain reporting \>65%.
Acceptability
时间窗: 8 weeks
Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item
次要结局
- Child pain intensity - parent report(8 weeks)
- Child pain intensity - child report(8 weeks)
- Child pain interference - parent report(8 weeks)
- Child pain interference - child report(8 weeks)
- Child health-related quality of life - parent report(8 weeks)
- Child health-related quality of life - child report(8 weeks)
- Parent quality of life(8 weeks)
- Parent pain management self-efficacy(8 weeks)
- Parent care satisfaction(8 weeks)
研究者
Lindsay Jibb
Principal Investigator
The Hospital for Sick Children