An mHealth Pain Coping Skills Training Intervention for Hematopoietic Stem Cell Transplantation Patients: Development and Pilot Randomized Controlled Trial.
An mHealth Pain Coping Skills Training Intervention for Hematopoietic Stem Cell Transplantation Patients: Development and Pilot Randomized Controlled Trial.
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DOI：
10.2196/mhealth.8565
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发表时间：
2018-03-19
影响因子：
5
通讯作者：
Keefe FJ
中科院分区：
文献类型：
--
作者：
Somers TJ;Kelleher SA;Dorfman CS;Shelby RA;Fisher HM;Rowe Nichols K;Sullivan KM;Chao NJ;Samsa GP;Abernethy AP;Keefe FJ
疼痛是造血干细胞移植（HCT）后患者面临的挑战。本研究旨在开发和测试基于Web的移动的疼痛应对技能培训（mPCST）方案的可行性、可接受性和初步疗效，该方案旨在满足HCT患者的需求。参与者接受了HCT并报告了移植后疼痛（N=68）。为了指导干预措施的制定，从焦点小组参与者（n=25）和完成用户测试的参与者（n=7）中收集定性数据。在他们的输入被整合到mPCST干预后，进行了一项试点随机对照试验（RCT，n=36），以检查干预的可行性，可接受性和初步疗效。收集可接受性、疼痛严重程度、疼痛残疾、疼痛自我效能、疲劳和身体残疾（自我报告和2分钟步行试验[2 MWT]）的测量结果。焦点小组和用户测试的参与者提供了定性数据，用于迭代完善mPCST方案。焦点小组定性数据包括参与者在移植后的疼痛经历，科普疼痛方法的观点，以及对其他HCT患者疼痛管理的建议。用户测试参与者提供了关于HCT协议的反馈和关于使用视频会议的信息。mPCST干预的最终版本旨在桥接强化门诊（1次面对面会议）和家庭环境（5次视频会议）。干预的一个关键组成部分是一个网站，该网站根据对疼痛和活动的日常评估提供个性化信息。该网站还提供干预材料（即电子讲义、短视频和音频文件）。干预内容包括来自其他移植患者的疼痛应对建议，以及如何在从事有意义的休闲活动时应用疼痛应对技能的指导。在本研究的RCT阶段，HCT患者（n=36）被随机分配接受mPCST干预或照常进行治疗。结果显示，mPCST参与者平均完成了6次会议中的5次。参与者报告说，干预是高度可接受的（平均3/4），他们发现会议是有帮助的（平均8/10）和容易理解的（平均7/7）。mPCST参与者在治疗前至治疗后疼痛、自我效能（P= 0.03，d=0.61）和2 MWT（P= 0.03，d=0.66）方面表现出显著改善，而常规治疗组的患者未报告任何此类改善。在两组中均发现疼痛残疾和疲劳的显著变化（多个P<0.02）; mPCST组的效应量幅度大于对照组（疼痛残疾：d=0.79 vs 0.69;疲劳：d=0.94 vs 0.81）。两组的疼痛严重程度均无显著变化。通过焦点小组和用户测试，我们开发了一种mPCST方案，该方案对患有疼痛的HCT患者是可行的、可接受的和有益的。ClinicalTrials.gov NCT 01984671; https://clinicaltrials.gov/ct2/show/NCT01984671（由WebCite在http：//www.webcitation.org/6xbpx3clZ上存档）
Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT). This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability (self-report and 2-min walk test [2MWT]) were collected. Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants’ experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio files). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36) were randomized to receive the mPCST intervention or to proceed with the treatment as usual. Results revealed that the mPCST participants completed an average of 5 out of 6 sessions. The participants reported that the intervention was highly acceptable (mean 3/4), and they found the sessions to be helpful (mean 8/10) and easy to understand (mean 7/7). The mPCST participants demonstrated significant improvements in pre- to post-treatment pain, self-efficacy (P=.03, d=0.61), and on the 2MWT (P=.03, d=0.66), whereas the patients in the treatment-as-usual group did not report any such improvements. Significant changes in pain disability and fatigue were found in both groups (multiple P<.02); the magnitudes of the effect sizes were larger for the mPCST group than for the control group (pain disability: d=0.79 vs 0.69; fatigue: d=0.94 vs 0.81). There were no significant changes in pain severity in either group. Using focus groups and user testing, we developed an mPCST protocol that was feasible, acceptable, and beneficial for HCT patients with pain. ClinicalTrials.gov NCT01984671; https://clinicaltrials.gov/ct2/show/NCT01984671 (Archived by WebCite at http://www.webcitation.org/6xbpx3clZ)