Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

摘要 疼痛是癌症幸存者中最常见的症状之一，但它往往仍然存在。 治疗不当。持续性和管理不善的疼痛在癌症治疗幸存者中很常见。 治疗指南指出，患者应接受疼痛应对技能培训（PCST）干预， 教授患者认知和行为应对技能，以减少疼痛和疼痛干扰，提高质量 生命当亲自交付时，PCST可以改善癌症患者的疼痛和功能，然而，这些 干预措施在临床护理中未得到充分利用，原因是资源成本高、缺乏训练有素的 治疗师、旅行要求和诊所就诊费用。为了解决这些障碍，我们开发了一个基于Web的PCST 使用专家系统方法的程序，旨在保留亲自PCST的治疗关键特征 不需要治疗师参与的治疗该程序（painTRAINER）通过定制模拟亲自PCST 算法和知识数据库，应用我们团队的专业培训和经验， PCST。母试验正在评估painTRAINER是否有效用于癌症相关的自我管理。 与常规医疗护理相比，完成治疗的癌症幸存者持续疼痛。的 该试验将通过NCI的国家社区肿瘤学在全国各地的社区进行 研究计划（NCORP）。IMPPERT正处于第1年（UG 3）里程碑驱动的规划阶段， 准备过渡到试验实施阶段（UH 3）。IMPPERT研究需要一个务实的， 随机对照临床试验，以确定painTRAINER加常规护理是否能显著 疼痛严重程度和疼痛干扰（简明疼痛量表）以及相关症状的改善 持续性疼痛的癌症幸存者从基线到干预后的结局（与常规治疗相比 单独）。这一行政补充要求提供资金，以支持最初未预见的行政和研究 在IMPACT试验的UG 3阶段和在以下情况下开发的设计修改： NCI工作人员，包括：1）提供额外资金，以支付因 批准增加样本量（从438例增加到456例; n=18例额外参与者）， 在功效分析中考虑标准差估计值和效应量的变化（总计54，000美元）; 2） 提供额外资金，支付因核准增加样本规模而产生的参与者奖励 (from 438至456; n=18名额外参与者）（总计1，800美元），以及3）提供额外资金以支付 NCORP自2008年以来实施的标准研究中心应计费用增加， IMPACT研究获得资助（每名参与者增加500美元），用于最初提议的n = 438例样本， 参与者（共计219，000美元）。

ABSTRACT Pain is one of the most common symptoms reported among cancer survivors, and yet it often remains inadequately treated. Persistent and poorly managed pain is commonplace among cancer treatment survivors. Treatment guidelines state patients should have access to pain coping skills training (PCST) interventions that teach patients cognitive and behavioral coping skills to reduce pain and pain interference and enhance quality of life. When delivered in-person, PCST can improve pain and functioning in people with cancer, and yet, these interventions are underused in clinical care due to barriers such as high resource costs, shortage of trained therapists, travel requirements, and costs of clinic visits. To address barriers, we developed a web-based PCST program using an expert systems approach designed to retain therapeutically critical features of in-person PCST that does not require therapist involvement. This program (painTRAINER) mimics in-person PCST via tailoring algorithms and a knowledge database that applies our team’s specialized training and experience in delivering PCST. The parent trial is evaluating whether painTRAINER is effective for self-management of cancer-related persistent pain among cancer survivors who have completed treatment as compared to usual medical care. The trial will be conducted at community sites across the country through the NCI’s National Community Oncology Research Program (NCORP). IMPACTS is in its Year 1 (UG3) milestone-driven planning phase and in preparation for transition to the trial implementation phase (UH3). The IMPACTS study entails a pragmatic, randomized controlled clinical trial to determine whether painTRAINER plus usual care yields significant improvements in pain severity and pain interference (Brief Pain Inventory) as well as in related symptom outcomes from baseline to post-intervention for cancer survivors with persistent pain (as compared to usual care alone). This administrative supplement requests funding to support initially unforeseen administrative and study design modifications that developed during the UG3 phase of the IMPACTS trial and under the advisement of NCI staff, including the following: 1) Provide additional funding to pay site accrual fees resulting from the approved increase in sample size (from 438 to 456; n=18 additional participants) that was implemented to account for changes in standard deviation estimates and effect sizes in power analyses (totaling $54,000); 2) Provide additional funding to pay participant incentives resulting from the approved increase in sample size (from 438 to 456; n=18 additional participants) (totaling $1,800), and 3) Provide additional funding to pay the increase in the standard site accrual fees that has been implemented by NCORP in the time since the IMPACTS study was funded (an increase of $500 per participant) for the originally proposed n = 438 sample of participants (totaling $219,000).