Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
Population Health Sciences, Duke University Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA.
Contemp Clin Trials. 2021 Mar;102:106287. doi: 10.1016/j.cct.2021.106287. Epub 2021 Jan 23.
Women with breast cancer in medically underserved areas are particularly vulnerable to persistent pain and disability. Behavioral pain interventions reduce pain and improve outcomes. Cancer patients in medically underserved areas receive limited adjunctive cancer care, as many lack access to pain therapists trained in behavioral interventions, face travel barriers to regional medical centers, and may have low literacy and limited resources. mHealth technologies have the potential to decrease barriers but must be carefully adapted for, and efficacy-tested with, medically underserved patients. We developed an mHealth behavioral pain coping skills training intervention (mPCST-Community). We now utilize a multisite randomized controlled trial to: 1) test the extent mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress; 2) examine potential mediators of intervention effects; and 3) evaluate the intervention's cost and cost-effectiveness.
METHODS/DESIGN: Breast cancer patients (N = 180) will be randomized to mPCST-Community or an attention control. mPCST-Community's four-session protocol will be delivered via videoconferencing at an underserved community clinic by a remote pain therapist at a major medical center. Videoconference sessions will be supplemented with a mobile application. Participants will complete self-report measures at baseline, post-intervention, and 3- and 6-month follow-ups.
mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas. This is one of the first trials to test an mHealth behavioral cancer pain intervention developed specifically for medically underserved communities. If successful, it could lead to widespread implementation and decreased health disparities.
医疗资源匮乏地区的乳腺癌女性特别容易持续疼痛和残疾。行为疼痛干预可减轻疼痛并改善预后。医疗资源匮乏地区的癌症患者接受的辅助癌症护理有限,因为许多人无法获得接受过行为干预培训的疼痛治疗师,前往区域医疗中心存在旅行障碍,并且可能文化程度低、资源有限。移动健康技术有可能减少障碍,但必须针对医疗资源匮乏的患者进行仔细调整,并进行疗效测试。我们开发了一种移动健康行为疼痛应对技能培训干预措施(mPCST-Community)。现在,我们利用一项多中心随机对照试验来:1)测试 mPCST-Community 减轻乳腺癌患者疼痛严重程度的程度(主要结果)、疼痛干扰、疲劳、身体残疾和心理困扰;2)研究干预效果的潜在介导因素;3)评估干预的成本和成本效益。
方法/设计:将 180 名乳腺癌患者随机分配至 mPCST-Community 或对照组。mPCST-Community 的四节方案将由远程疼痛治疗师在一个主要医疗中心通过视频会议在一个服务不足的社区诊所提供。视频会议将辅以移动应用程序。参与者将在基线、干预后以及 3 个月和 6 个月的随访时完成自我报告的测量。
mPCST-Community 有可能减轻疼痛和残疾,并减少医疗资源匮乏地区癌症患者的障碍。这是第一个测试专门为医疗资源匮乏社区开发的移动健康行为癌症疼痛干预措施的试验之一。如果成功,它可能会导致广泛实施并减少健康差距。