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

通过互联网对癌症治疗幸存者进行疼痛管理 (IMPACTS)

• 批准号: 10219647
• 负责人: DONALD BAIRD PENZIEN
• 金额: $ 16.55万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10219647
• 关键词: Address; Administrative Supplement; Algorithms; Behavioral; Brief Pain Inventory; Cancer Survivor; Caring; Clinic Visits; Cognitive; Communities; Community Clinical Oncology Program; Coping Skills; Country; Databases; Educational Intervention; Expert Systems; Fees; Funding; Incentives; Internet; Intervention; Knowledge; Malignant Neoplasms; Medical; Modification; Online Systems; Outcome; Pain; Pain interference; Pain management; Parents; Participant; Patients; Persistent pain; Persons; Phase; Preparation; Quality of life; Randomized Controlled Clinical Trials; Reporting; Research; Research Design; Resources; Sample Size; Sampling; Self Management; Severities; Site; Survivors; Symptoms; Therapeutic; Time; Training; Training Programs; Travel; cancer therapy; chronic pain management; clinical care; clinical practice; common symptom; cost; design; experience; improved; mHealth; pain reduction; parent grant; post intervention; power analysis; practice setting; programs; skills training; treatment as usual; treatment guidelines

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).

抽象的 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。持续且管理不善的疼痛在癌症治疗幸存者中很常见。 治疗指南规定患者应该接受疼痛应对技能培训 (PCST) 干预措施， 教导患者认知和行为应对技巧，减少疼痛和疼痛干扰，提高质量 的生活。当亲自进行时，PCST 可以改善癌症患者的疼痛和功能，然而，这些 由于资源成本高、训练有素的人员短缺等障碍，干预措施在临床护理中未得到充分利用 治疗师、旅行要求以及就诊费用。为了解决障碍，我们开发了基于网络的 PCST 使用专家系统方法的计划旨在保留面对面 PCST 的治疗关键特征 这不需要治疗师的参与。该程序（painTRAINER）通过定制模仿面对面的 PCST 算法和知识数据库，应用我们团队的专业培训和交付经验 PCST。母试验正在评估 painTRAINER 对癌症相关患者的自我管理是否有效 与常规医疗护理相比，完成治疗的癌症幸存者中存在持续性疼痛。这 试验将通过 NCI 的国家社区肿瘤学在全国各地的社区站点进行 研究计划（NCORP）。 IMPACTS 正处于第 1 年 (UG3) 里程碑驱动的规划阶段 准备过渡到试实施阶段（UH3）。 IMPACTS 研究需要务实的、 随机对照临床试验，以确定 painTRAINER 加上常规护理是否产生显着效果 疼痛严重程度和疼痛干扰（简要疼痛清单）以及相关症状的改善 患有持续性疼痛的癌症幸存者从基线到干预后的结果（与常规护理相比） 独自的）。本行政补充文件要求提供资金以支持最初不可预见的行政和研究 在 IMPACTS 试验的 UG3 阶段并在以下人员的建议下进行的设计修改 NCI 工作人员，包括以下人员： 1) 提供额外资金以支付因 批准增加样本量（从 438 名增加到 456 名；n=18 名额外参与者） 考虑功效分析中标准差估计值和效应大小的变化（总计 54,000 美元）； 2） 提供额外资金来支付因批准的样本量增加而产生的参与者奖励 （从 438 人增加到 456 人；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 自 NCORP 实施以来，增加了标准场地应计费用 IMPACTS 研究获得资助（每位参与者增加 500 美元），最初提出的 n = 438 个样本 参与者（总计 219,000 美元）。