A Mobile Health Behavioral Pain Intervention Protocol for Breast Cancer Patients with Pain in Medically Underserved Communities: A Randomized Controlled Trial

旨在减少疼痛和疼痛的移动的健康（mHealth）行为癌症疼痛干预的疗效 尚未对医疗服务不足地区的乳腺癌患者的残疾情况进行调查。长期 这项工作的目标是利用移动医疗技术，以促进广泛实施有效的 行为癌症疼痛干预-疼痛管理的非药物方法。拟议 项目的目标是展示创新的移动的健康疼痛应对技能培训的有效性 （mPCST-社区）旨在满足医疗服务不足的乳腺癌疼痛患者的需求 地区mPCST-社区解决了医疗服务不足地区患者的干预障碍，因为它是 由远程治疗师在患者社区的肿瘤诊所通过视频会议提供， 使用简单的移动健康技术扩展到患者的家庭环境，并适应低识字率。的 中心假设是，与移动健康教育相比，mPCST社区将导致疼痛减少 注意力控制组（mHealth-Ed）。该建议的基本原理是，如果mPCST社区被证明是 它将迅速增加接受肿瘤治疗的个人的干预机会， 并最终减少与疼痛有关的痛苦。在强有力的初步数据的指导下， 对照试验将用于追求三个具体目标：1）测试mPCST-社区 干预减少疼痛，疲劳，残疾和痛苦，2）检查自我效能和疼痛灾难化， 介导mPCST-社区导致疼痛、疲劳、残疾和痛苦减少的介质，以及 3)评估mPCST-社区的成本效益。对于目标1，根据研究小组的广泛研究， 工作证明了面对面疼痛应对技能培训方案的有效性，试点工作显示出希望 对于mPCST-Community，预期mPCST-Community将导致疼痛和疲劳减少， 对于目标2，预计mPCST-社区的影响 将通过增加疼痛控制的自我效能和减少疼痛灾难化来介导。对于目标3来说，它是 预计mPCST社区将证明全因医疗评估的成本效益 资源使用、参与者和治疗师时间、健康效用以及成功的总体应计，高受试者 保持和高干预依从性。这项创新的应用提出了第一项研究，以检查 mPCST社区旨在解决医疗服务不足的癌症患者的疼痛的疗效 地区虽然改善获得护理的机会至关重要，但提供有效的护理也同样重要。如果mPCST- 社区被证明是有效的，它将提供一种干预措施，可以迅速实施到 癌症患者的疼痛护理。重要的是，如果有效，这种干预可以提供一个必要的模式， 其他慢性疼痛患者人群的非药物疼痛管理方法。

The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention – a non-pharmacological approach to pain management. The proposed project’s objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients with pain in medically underserved areas. mPCST-Community addresses intervention barriers for patients in medically underserved areas as it is delivered with video-conferencing in the patients’ community based oncology clinic by a remote therapist, is extended to the patients’ home environment using simple mHealth technology, and is low-literacy adapted. The central hypothesis is that mPCST-Community will result in decreased pain compared to a mHealth education attention control group (mHealth-Ed). The rationale of this proposal is that if mPCST-Community is shown to be efficacious it will rapidly increase intervention access for individuals who receive their oncology care in medically underserved areas and ultimately reduce pain-related suffering. Guided by strong preliminary data, a randomized controlled trial will be used to pursue three specific aims: 1) Test the extent to which the mPCST-Community intervention reduces pain, fatigue, disability, and distress, 2) Examine self-efficacy and pain catastrophizing as mediators through which the mPCST-Community leads to reductions in pain, fatigue, disability, and distress, and 3) To evaluate the cost-effectiveness of mPCST-Community. For Aim 1, based on the study team’s extensive work demonstrating the efficacy of in-person pain coping skills training protocols and pilot work showing promise for mPCST-Community, it is expected that mPCST-Community will lead to decreased pain as well as fatigue, disability, and distress compared to mHealth-Ed. For Aim 2, it is expected that the effects of mPCST-Community will be mediated by increased self-efficacy for pain control and decreased pain catastrophizing. For Aim 3, it is expected that mPCST-Community will demonstrate cost-effectiveness as assessed by all-cause medical resource use, participant and therapist time, and health utilities as well as successful overall accrual, high subject retention, and high intervention adherence. This innovative application proposes the first study to examine the efficacy of mPCST-Community that is designed to address pain in cancer patients in medically underserved areas. While improving access to care is critical, providing efficacious care is just as important. If mPCST- Community is shown to be efficacious, it will provide an intervention that can be rapidly implemented into the care of cancer patients with pain. Importantly, if efficacious this intervention could provide a needed model for non-pharmacological approaches to pain management for other populations of patients with chronic pain.