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

针对医疗服务不足的社区中患有疼痛的乳腺癌患者的移动健康行为疼痛干预方案：随机对照试验

• 批准号: 10543415
• 负责人: Tamara J Somers
• 金额: $ 62.39万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-10 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10543415
• 关键词: Address; Adherence; Arthritis; Behavior Therapy; Behavioral; Breast Cancer Patient; Cancer Patient; Caring; Cellular Phone; Clinic; Communities; Control Groups; Coping Skills; Cost Analysis; Cost Savings; Data; Distress; Doctor of Philosophy; Education; Educational Intervention; Effectiveness; Face; Fatigue; Feedback; Focus Groups; Future; Goals; Health; Health Services Accessibility; Healthcare; Home; Home environment; Improve Access; Incidence; Individual; Intervention; Journals; Life; Malignant Neoplasms; Mediating; Mediator; Medical; Medical center; Medically Underserved Area; Mission; Modeling; Oncology; Outcome; Pain; Pain interference; Pain management; Participant; Patients; Persistent pain; Persons; Protocols documentation; Public Health; Quality of life; Randomized, Controlled Trials; Recommendation; Relaxation; Research; Resources; Rural Community; Sampling; Self Efficacy; Severities; Technology; Testing; Text; Time; Training; Transportation; Travel; United States National Institutes of Health; Videoconferencing; Woman; Work; arm; attentional control; behavioral health; cancer care; cancer pain; chronic pain patient; community clinic; community intervention; coping; cost; cost effective; cost effectiveness; cost per quality-adjusted life year; cost-effectiveness evaluation; design; disability; efficacious intervention; efficacy evaluation; efficacy testing; health care disparity; improved; improved outcome; incremental cost; innovation; literacy; mHealth; malignant breast neoplasm; medically underserved; mobile application; pain catastrophizing; pain outcome; pain reduction; patient population; patient-level barriers; physically handicapped; post intervention; primary outcome; psychological distress; psychosocial; recruit; remote therapy; skills training; symptom management; therapy design; underserved community

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.

移动健康(MHealth)行为癌症疼痛干预的有效性旨在减少疼痛和 在医疗服务不足的地区，乳腺癌患者的残疾情况尚未得到调查。长期的 这项工作的目标是利用移动健康技术来促进有效的 行为癌症疼痛干预--疼痛管理的非药理学方法。建议数 该项目的目标是展示一种创新的移动医疗疼痛应对技能培训的有效性 (mPCST-社区)旨在满足乳腺癌患者在医疗服务不足时疼痛的需求 区域。MPCST-社区解决医疗服务不足地区患者的干预障碍 由远程治疗师在患者社区肿瘤诊所提供视频会议，IS 使用简单的mHealth技术扩展到患者的家庭环境，并适应低识字率。这个 中心假设是，与mHealth教育相比，mPCST-Community将减少疼痛 注意对照组(mHealth-ED)。这项提议的基本原理是，如果mPCST-Community被证明是 它将迅速增加接受肿瘤内科治疗的个人的干预途径 在服务不足的地区，消除贫困，最终减少与疼痛有关的痛苦。在强劲的初步数据指导下，随机 对照试验将用于实现三个具体目标：1)测试MPCST-社区的程度 干预减少疼痛、疲劳、残疾和痛苦，2)检查自我效能感和疼痛灾难 MPCST-社区通过这些调解人减少疼痛、疲劳、残疾和痛苦，以及 3)评价MPCST-Community的成本-效果。对于目标1，基于研究团队的广泛 展示面对面疼痛应对技能培训方案的有效性的工作和展示前景的试点工作 对于mPCST-社区，预计mPCST-社区将减少疼痛和疲劳， 与mHealth-Ed相比，残疾和痛苦。对于目标2，预计MPCST--社区的影响 将通过提高疼痛控制的自我效能和减少疼痛灾难来实现。对于目标3，它是 预计MPCST-社区将展示由全因医疗评估的成本效益 资源使用、参与者和治疗师的时间、健康效用以及成功的总体收益、高主题 保留率和较高的干预依从性。这一创新的应用程序提出了第一项研究，以检查 旨在解决医疗服务不足的癌症患者疼痛的mPCST-Community的疗效 区域。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 照顾癌症患者的疼痛。重要的是，如果有效，这种干预可以提供一个必要的模式 其他慢性疼痛患者的非药理学疼痛管理方法。