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: 10630101
• 负责人: Christine Rini
• 金额: $ 62.88万
• 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/10630101
• 关键词: Address; Adherence; Adverse effects; Affect; Aftercare; Algorithms; Aromatase Inhibitors; Arthralgia; Behavior Therapy; Behavioral; Breast Cancer survivor; Caring; Cessation of life; Clinical; Cognitive; Cognitive Therapy; Communities; Contralateral Breast; Coping Skills; Databases; Degenerative polyarthritis; Distress; Educational process of instructing; Exercise; Feedback; Future; Geographic Locations; Guidelines; Health; Hot flushes; Internet; Intervention; Interview; Knee Osteoarthritis; Knowledge; Link; Malignant Neoplasms; Measures; Mediating; Medical; Methods; Minority; 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; Recurrent Malignant Neoplasm; Relaxation; Reporting; Research; Resources; Risk Reduction; Self Efficacy; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Structure; Survivors; Symptoms; Telephone; Testing; Therapeutic; Toxic effect; Training; Training Programs; Travel; Woman; cancer pain; cancer recurrence; chronic musculoskeletal pain; clinical care; cognitive reappraisal; contactin; cost; design; disability; emotional distress; evidence base; experience; health related quality of life; hormone receptor-positive; improved; inhibitor therapy; innovation; joint stiffness; knee pain; 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; symposium; therapy development; therapy duration; treatment as usual; tumor; vasomotor symptoms

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 (AI) 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+) 肿瘤的 AI 可以提高生存率并降低癌症复发的风险。 它们还会造成严重的副作用，最常见的是关节痛——关节疼痛和僵硬。 大约 50% 的 BCS 在开始 AI 后不久就开始出现疼痛性关节痛，导致情绪困扰和贫困。 与健康相关的生活质量（HRQoL）也是与人工智能依从性问题最密切相关的人工智能副作用， 这是当前治疗疼痛关节痛的一个重要的医学问题。 仅帮助少数BCS，导致限制其使用的毒性，或证据薄弱，揭示了关键差距 使用 AI 来减少疼痛性关节痛对 BCS 的影响的能力有限，我们建议用 AI 来填补这一关键空白。 疼痛应对技能训练 (PCST)，一种基于认知行为疗法 (CBT) 的干预措施。 据了解，目前还没有研究评估 PCST 治疗 AI 相关疼痛性关节痛的效果，尽管 随机对照试验 (RCT) 表明，经过培训的治疗师提供 PCST 和类似干预措施 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 尽管有效，但由于高等障碍，PCST 在临床护理中的使用仍然不足。 资源成本、某些地理区域缺乏可用性、患者的旅行需求以及短缺 我们开发了一个名为 painTRAINER 的基于网络的 PCST 程序来克服这些障碍， 使用一种新颖的方法来优化参与并保留治疗师交付的治疗关键特征 PCST 是一个“自动化”程序，不需要治疗师参与，可以高度模仿。 治疗师提供的交互式和个性化 PCST 证据表明 painTRAINER 高度有效。 可接受且有吸引力，并且它可以减轻骨关节炎 (OA) 患者的关节疼痛和僵硬。 现在寻求评估它是否可以改善疼痛性关节痛的严重程度及其相关的干扰和 AI 治疗对 BCS 的其他不利影响 拟议的多中心随机对照试验将随机分组 452 名接受 AI 治疗的 BCS。 与疼痛性关节痛相关的强化常规护理 (EUC) 或 painTRAINER+EUC 评估将在以下时间进行。 基线、干预后（基线后 12 周）以及干预后 3 个月和 6 个月。 确定与 EUC 相比 painTRAINER+EUC 是否改善疼痛严重程度和疼痛干扰（目标 1，主要结果）以及痛苦、HRQoL 和 AI 依从性（目标 2，次要结果）。 确定这些对主要和次要结果的影响是否至少部分是由增加所介导的 最后，我们将评估一个探索性目标。 除了参与者聚集之外，对睡眠问题和血管舒缩症状也有有益的间接影响 关于 painTRAINER 适合他们独特需求的反馈 该随机对照试验可以产生高度传播的干预措施。 可以在临床上快速实施，包括在 PCST 获取机会有限的地理区域。