Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial

基于网络的疼痛应对技能培训，以改善乳腺癌幸存者芳香酶抑制剂相关关节痛引起的疼痛和依从性差（SKIP-关节痛）：一项随机对照试验

• 批准号: 10439192
• 负责人: Christine Rini
• 金额: $ 65.36万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10439192
• 关键词: Address; Adherence; Adverse effects; Affect; Aftercare; Algorithms; Aromatase Inhibitors; Arthralgia; Behavior Therapy; Behavioral; Breast Cancer survivor; Caring; Cessation of life; Chronic; Clinical; Cognitive; Cognitive Therapy; Communities; Contralateral Breast; Coping Skills; Databases; Degenerative polyarthritis; Distress; Emotional; Exercise; Feedback; Future; Geographic Locations; Guidelines; Health; Hot flushes; Internet; Intervention; Interview; Knee Osteoarthritis; Knowledge; Link; Malignant Neoplasms; Measures; Mediating; Medical; Methods; Minority; Musculoskeletal; Night Sweating; Online Systems; Pain; Pain interference; Pain management; Participant; Patient Self-Report; Patient-Focused Outcomes; Patients; Personal Satisfaction; Persons; Physical Function; Postmenopause; Randomized; Randomized Controlled Trials; Relaxation; Reporting; Research; Resources; Self Efficacy; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Structure; Survivors; Symptoms; Testing; Therapeutic; Toxic effect; Training; Training Programs; Travel; Vasomotor; Woman; cancer recurrence; cancer risk; chronic musculoskeletal pain; clinical care; cognitive reappraisal; cost; design; disability; emotional distress; evidence base; experience; health related quality of life; hormone receptor-positive; improved; inhibitor therapy; innovation; joint stiffness; malignant breast neoplasm; non-drug; novel; novel strategies; pain catastrophizing; pain reduction; post intervention; primary endpoint; primary outcome; programs; rural area; secondary outcome; side effect; skills; skills training; therapy development; therapy duration; treatment as usual; tumor

Aromatase inhibitors (AIs) are standard post-treatment care for postmenopausal breast cancer survivors (BCS) with hormone-receptor positive (HR+) tumors. AIs improve survival and reduce risk for cancer recurrence, but they also cause significant adverse effects. The most common is arthralgia—joint pain and stiffness that affects about 50% of BCS beginning soon after starting an AI. Painful arthralgia causes emotional distress and poor health-related quality of life (HRQoL). It is also the AI side effect most strongly linked to AI adherence problems, which are a critical medical concern. Current medical and behavioral interventions for managing painful arthralgia help only a minority of BCS, cause toxicities that limit their use, or have weak evidence, revealing a critical gap limiting ability to reduce the impact of painful arthralgia on BCS using AIs. We propose to fill this critical gap with Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention. To our knowledge, no study has evaluated PCST for management of AI-associated painful arthralgia, although randomized controlled trials (RCTs) show that PCST and similar interventions delivered by trained therapists can improve pain and reduce disability in people with cancer, chronic musculoskeletal pain, and other pain conditions. Despite efficacy, PCST continues to be underused in clinical care due to barriers such as high resource costs, lack of availability in some geographic areas, travel requirements for patients, and a shortage of trained therapists. We developed a web-based PCST program called painTRAINER to overcome these barriers, using a novel approach to optimize engagement and retain therapeutically critical features of therapist-delivered PCST in an “automated” program that does not require therapist involvement. PainTRAINER mimics highly interactive and personalized therapist-delivered PCST. RCT evidence shows that painTRAINER is highly acceptable and engaging, and that it can reduce joint pain and stiffness in people with osteoarthritis (OA). We now seek to evaluate whether it can improve the severity of painful arthralgia and its associated interference and other adverse impacts on BCS on AI therapy. The proposed multi-site RCT will randomize 452 BCS with AI- associated painful arthralgia to enhanced usual care (EUC) or painTRAINER+EUC. Assessments will occur at baseline, post-intervention (12 weeks after baseline), and 3- and 6-months post-intervention. Aims are to determine whether painTRAINER+EUC, compared to EUC, improves pain severity and pain interference (Aim 1, primary outcomes) as well as distress, HRQoL, and AI adherence (Aim 2, secondary outcomes). We will also determine whether these effects on primary and secondary outcomes are at least partially mediated by increases in pain self-efficacy and reductions in pain catastrophizing (Aim 3). Finally, for an exploratory aim we will evaluate beneficial indirect effects on sleep problems and vasomotor symptoms in addition to gathering participant feedback on painTRAINER’s fit for their unique needs. This RCT could yield a highly disseminable intervention that could be quickly implemented clinically, including in geographic areas with limited access to PCST.

芳香酶抑制剂（AIS）是绝经后乳腺癌存活（BCS）的标准治疗后护理 伴有阳性（HR+）肿瘤。 AIS提高生存率并降低癌症复发的风险，但 它们还会造成严重的不利影响。最常见的是关节痛 - 影响的接头疼痛和僵硬 大约50％的BC开始在开始AI后不久就开始了。痛苦的关节痛会导致情绪困扰和差 与健康相关的生活质量（HRQOL）。它也是与AI依从性问题最密切相关的AI副作用， 这是一个关键的医疗问题。当前的医疗和行为干预措施用于管理痛苦的关节痛 仅帮助少数BC，导致限制其使用或证据较弱的毒性 使用AIS减少痛苦的关节痛对BC的影响的限制能力。我们建议用 疼痛应对技巧培训（PCST），一种认知行为疗法（CBT）的干预措施。向我们 知识，没有研究评估PCST用于管理AI相关的痛苦的关节痛，但是 随机对照试验（RCT）表明，训练有素的治疗师提供的PCST和类似干预措施 可以改善癌症患者，慢性肌肉骨骼疼痛和其他疼痛的疼痛 状况。尽管有效率，但由于诸如高的障碍，PCST仍在临床护理中不足 资源成本，某些地理区域缺乏可用性，患者的旅行要求以及短缺 训练有素的治疗师。我们开发了一个基于网络的PCST程序，称为Paintrainer，以克服这些障碍， 使用一种新颖的方法来优化参与度并保留治疗师的治疗特征 PCST在不需要治疗师参与的“自动化”程序中。止痛药模仿 交互式和个性化的治疗师分配了PCST。 RCT证据表明，止痛药高度 可以接受和引人入胜，并且可以减轻骨关节炎（OA）患者的关节疼痛和僵硬。我们 现在寻求评估它是否可以改善痛苦的关节痛及其相关干扰的严重程度 对BCS对AI疗法的其他不利影响。拟议的多站点RCT将与AI-452 BC随机进行452 BC 相关的痛苦的关节痛以增强常规护理（EUC）或止痛+EUC。评估将在 基线，干预后（基线后12周）以及干预后3个月和6个月。目的是 确定止痛药+EUC是否与EUC相比是否可以改善疼痛的严重程度和疼痛干扰（AIM 1，主要结果）以及困扰，HRQOL和AI依从性（AIM 2，次要结果）。我们也会 确定这些对主要结果和次要结果的影响是否至少通过增加而部分介导 在疼痛自我效能和疼痛灾难性的减轻中（AIM 3）。最后，对于探索目的，我们将评估 除了收集参与者之外，对睡眠问题和血管舒适症状的有益间接影响 止痛药的反馈适合其独特的需求。该RCT可能会产生高度可观的干预措施 可以在临床上快速实施，包括在访问PCST的地理区域。