Patton Michaela, Carlson Linda E, Noel Melanie, Palermo Tonya, Forster Victoria, Cho Sara, Schulte Fiona
Department of Psychology, University of Calgary, Calgary, AB, Canada.
Seattle Children's Research Institute, Seattle, WA, United States.
JMIR Res Protoc. 2023 Aug 1;12:e45804. doi: 10.2196/45804.
There are over 500,000 survivors of childhood cancer in North America alone. One in 4 survivors experiences chronic pain after treatment has been completed. Youths with chronic pain report increased anxiety, depression, activity limitations, and sleep disturbances. An 8-week web-based cognitive behavioral treatment for chronic pain (Web-Based Management of Adolescent Pain [WebMAP]) has demonstrated a reduction in pain in youths but has not yet been explored in survivors.
The objectives of this study are to (1) test the feasibility and acceptability of WebMAP for a sample of survivors with chronic pain and their parents; (2) assess the acceptability of WebMAP using qualitative interviews; (3) assess WebMAP's effect on activity limitations, pain intensity, depression and anxiety symptoms, and sleep disturbances; and (4) assess WebMAP's effect on parent pain catastrophizing and parental response to their child's pain.
A single-arm mixed methods pre-post intervention study design will be used. Participants will be 34 survivors and at least one of their parents or caregivers. Inclusion criteria are (1) a cancer history, (2) current age of 10-17 years, (3) >2 years post treatment or >5 years post diagnosis, (4) pain present over prior 3 months impairing >1 area of daily life and occurring >1 time per month, and (5) computer access with broadband internet. Survivors will complete a pretreatment questionnaire, which will include the following: the Child Activity Limitations Interview, the pain intensity Numerical Rating Scale, Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference, Anxiety, Depression, Insomnia Severity Index, and Adolescent Sleep Wake Scale. Parents will complete the Pain Catastrophizing Scale-Parent Version and the Adult Responses to Child Symptoms. Upon completion of pretreatment questionnaires (T0), survivors will begin WebMAP. After the 8-week intervention, survivors will complete the same measures (T1), and at 3-month follow-up (T2). Posttreatment interviews will be conducted to determine acceptability. Feasibility will be assessed via recruitment and retention rates. Treatment engagement will be measured by number of modules completed. Pre-post outcome data will be assessed using linear mixed models. Qualitative data will be analyzed using thematic analysis. Patient partners will be involved in study design, recruitment, interpretation of results, and knowledge translation.
This study has been funded in January 2022. Data collection started in May 2022 and is projected to end in August 2023. We have enrolled 10 participants as of December 2022.
Investigating whether WebMAP is useful to survivors will be an important step in improving pain management in this population.
ClinicalTrials.gov NCT05241717; https://clinicaltrials.gov/ct2/show/NCT05241717.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45804.
仅在北美，就有超过50万名儿童癌症幸存者。每4名幸存者中就有1人在治疗结束后经历慢性疼痛。患有慢性疼痛的青少年报告称焦虑、抑郁、活动受限和睡眠障碍有所增加。一种为期8周的基于网络的慢性疼痛认知行为疗法（青少年疼痛网络管理[WebMAP]）已证明可减轻青少年的疼痛，但尚未在幸存者中进行探索。
本研究的目的是：（1）测试WebMAP对一组患有慢性疼痛的幸存者及其父母的可行性和可接受性；（2）通过定性访谈评估WebMAP的可接受性；（3）评估WebMAP对活动受限、疼痛强度、抑郁和焦虑症状以及睡眠障碍的影响；（4）评估WebMAP对父母疼痛灾难化以及父母对孩子疼痛的反应的影响。
将采用单臂混合方法干预前后研究设计。参与者将是34名幸存者以及他们至少一名父母或照顾者。纳入标准为：（1）有癌症病史；（2）当前年龄为10 - 17岁；（3）治疗后超过2年或诊断后超过5年；（4）过去3个月内出现的疼痛损害了超过1个日常生活领域且每月发生超过1次；（5）可使用宽带互联网接入计算机。幸存者将完成一份预处理问卷，其中将包括以下内容：儿童活动受限访谈、疼痛强度数字评定量表、患者报告结局测量信息系统（PROMIS）-疼痛干扰、焦虑、抑郁、失眠严重程度指数和青少年睡眠-觉醒量表。父母将完成疼痛灾难化量表-父母版和成人对儿童症状的反应。在完成预处理问卷（T0）后，幸存者将开始WebMAP。在为期8周的干预结束后，幸存者将完成相同的测量（T1），并在3个月随访时（T2）完成。将进行治疗后访谈以确定可接受性。将通过招募和保留率评估可行性。治疗参与度将通过完成的模块数量来衡量。干预前后的结局数据将使用线性混合模型进行评估。定性数据将使用主题分析进行分析。患者合作伙伴将参与研究设计、招募、结果解释和知识转化。
本研究已于2022年1月获得资助。数据收集于2022年5月开始，预计于2023年8月结束。截至2022年12月，我们已招募了10名参与者。
调查WebMAP对幸存者是否有用将是改善该人群疼痛管理的重要一步。
ClinicalTrials.gov NCT05241717；https://clinicaltrials.gov/ct2/show/NCT05241717。
国际注册报告识别码（IRRID）：DERR1-10.2196/45804。
