Pain Caregiver Resource (PainCaRe)

Официальное название

Building mHealth Parent Capacity to Manage Pain in Young Children With Cancer: A Pilot Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое Pain Caregiver Resource (PainCaRe)
  The purpose of the PainCaRe mobile health app is to support parents of young children with cancer (between the ages of 2-11 years) to manage their cancer-related pain at home. The app will ask caregivers to completed a brief 6-question pain assessment once daily and complete ad hoc assessments as needed. Based on the results of the pain assessment, real-time, evidence-based pain management suggestions, including will be provided to parents. The purpose of the pilot randomized controlled trial (R

Первичные конечные точки

• Feasibility - attrition [Срок оценки: 1 year]
• Feasibility - accrual [Срок оценки: 1 year]
• Feasibility - adherence [Срок оценки: 8 weeks]
• Acceptability [Срок оценки: 8 weeks]

Вторичные конечные точки (9)

• Child pain intensity - parent report [Срок оценки: 8 weeks]
• Child pain intensity - child report [Срок оценки: 8 weeks]
• Child pain interference - parent report [Срок оценки: 8 weeks]
• Child pain interference - child report [Срок оценки: 8 weeks]
• Child health-related quality of life - parent report [Срок оценки: 8 weeks]
• Child health-related quality of life - child report [Срок оценки: 8 weeks]
• Parent quality of life [Срок оценки: 8 weeks]
• Parent pain management self-efficacy [Срок оценки: 8 weeks]
• Parent care satisfaction [Срок оценки: 8 weeks]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Оценка устройства

Центры проведения

Канада · 1 центр

• The Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT06651190 · 1000081481

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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