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

芳香酶抑制剂(Ais)是绝经后乳腺癌幸存者(Bcs)的标准治疗后护理。 激素受体阳性(HR+)肿瘤。人工智能可提高存活率，降低癌症复发风险，但 它们还会造成严重的不利影响。最常见的是关节痛--影响关节的疼痛和僵硬 大约50%的BCS在开始人工智能后不久开始。痛性关节痛会导致情绪困扰和贫穷 健康相关生活质量(HRQOL)。这也是与人工智能坚持问题联系最紧密的人工智能副作用， 这是一个严重的医疗问题。治疗痛性关节痛的现代医学和行为干预 只帮助一小部分BCS，导致限制其使用的毒性，或者证据薄弱，暴露出严重的差距 使用AIS减少疼痛关节痛对BCS的影响的能力有限。我们建议用以下方式填补这一关键空白 疼痛应对技能培训(PCST)，一种认知行为疗法(CBT)知情的干预。致我们的 知识，还没有研究评估PCST治疗AI相关的疼痛关节痛，尽管 随机对照试验(RCT)显示，PCST和类似的干预措施由训练有素的治疗师提供 可以改善癌症、慢性肌肉骨骼疼痛和其他疼痛患者的疼痛并减少残疾 条件。尽管有效，但PCST在临床护理中仍未得到充分利用，原因是 资源成本、一些地理区域缺乏可获得性、患者的旅行要求以及缺乏 训练有素的心理医生。我们开发了一个基于网络的PCST程序，名为PainTRAINER来克服这些障碍， 使用一种新方法来优化参与度并保留治疗师提供的治疗关键特征 PCST是一种“自动”程序，不需要治疗师的参与。PainTRAINER高度模仿 互动和个性化治疗师提供的PCST。RCT证据显示PainTRAINER对 它是可接受和吸引人的，它可以减轻骨关节炎(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疼痛关节痛的严重程度及其相关的干预和 人工智能治疗对BCS的其他不良影响。拟议的多站点随机对照试验将使用人工智能随机选择452个BCS- 与疼痛相关的关节痛与加强日常护理(EUC)或疼痛治疗+EUC有关。评估将在 基线、干预后(基线后12周)、干预后3个月和6个月。目标是 确定与EUC相比，PainTRAINER+EUC是否可以改善疼痛严重程度和疼痛干预(AIM 1，主要结果)以及苦恼、HRQL和AI依从性(目标2，次要结果)。我们还将 确定这些对主要和次要结果的影响是否至少部分地通过增加来调节 在疼痛自我效能感和减少疼痛灾难方面(目标3)。最后，为了探索性的目的，我们将评估 除了聚集参与者外，还对睡眠问题和血管舒缩症状产生有益的间接影响 对PainTRAINER适合他们独特需求的反馈。这种随机对照试验可以产生高度可传播的干预措施。 这可能很快在临床上实施，包括在获得PCST机会有限的地理地区。

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.