Development and piloting of an intervention to reduce the impact of opioid stigma in cancer pain

开发和试点一项干预措施，以减少阿片类药物耻辱对癌症疼痛的影响

• 批准号: 10448644
• 负责人: Hailey Waddell Bulls
• 金额: $ 14.57万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-07 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10448644
• 关键词: Address; Advanced Development; Advanced Malignant Neoplasm; Adverse event; Area; Assertiveness; Award; Behavior; Behavior Therapy; Behavioral; Cancer Center; Cancer Pain Management; Caregivers; Caring; Cessation of life; Characteristics; Client satisfaction; Clinical Practice Guideline; Communication; Communities; Conduct Clinical Trials; Coping Skills; Data; Development; Elements; Enrollment; Feedback; Foundations; Fright; Future; Health; Health behavior; High Risk Woman; Impairment; Intervention; Intervention Trial; Label; Link; Literature; Malignant Neoplasms; Mentors; Mentorship; Methodology; Mission; Not Hispanic or Latino; Oncology; Opioid; Opioid Analgesics; Outcome; Outcome Assessment; Overdose; Pain; Pain management; Pain quality; Participant; Patients; Personal Satisfaction; Persons; Preparation; Principal Investigator; Process; Publishing; Qualitative Research; Quality of life; Randomized; Reporting; Research; Research Methodology; Research Personnel; Research Support; Resources; Social isolation; Stereotyping; Stress and Coping; Surveys; Symptoms; Testing; Time; Training; Underserved Population; United States; Woman; acceptability and feasibility; addiction; adherence rate; adverse outcome; base; cancer pain; cancer therapy; career; career development; concept mapping; design; efficacy testing; efficacy trial; emotional distress; experience; health related quality of life; high risk; improved; innovation; internalized stigma; multidisciplinary; novel; opioid epidemic; opioid policy; opioid use; palliative; patient-clinician communication; people of color; pilot test; pilot trial; post intervention; prescription opioid; primary outcome; randomized trial; rural area; skills; social; social cognitive theory; social stigma; theories; therapy development; tool; treatment as usual; underserved community

ABSTRACT Moderate-to-severe cancer pain is common in patients with advanced cancer and is often effectively treated with prescription opioids. Effective pain management is crucial for optimal quality of life and health outcomes in these patients. However, the emergence of the opioid crisis in the United States has sparked widespread fears about the use of opioid pain medications, given the potential for negative outcomes such as addiction and overdose. Despite being exempted from restrictive opioid policies, patients with cancer experience adverse consequences of efforts to address the opioid crisis, including stigma associated with prescription opioid use (“opioid stigma”). Based on our recently published Opioid Stigma Framework, we anticipate that opioid stigma results in several proximal (e.g., impaired patient-provider communication, suboptimal health behaviors, emotional distress, maladaptive coping skills) and long-term health consequences (e.g., less effective pain management, reduced health-related quality of life). Emerging evidence indicates that opioid stigma is common, pervasive, and has the potential to seriously impact patient well-being. However, there are no known interventions to mitigate opioid stigma in patients with advanced cancer. Additionally, perspectives from underserved communities at high risk for pain undertreatment – people of color, people in rural areas, and women – are lacking, and understanding these experiences is critical to build a robust, inclusive opioid stigma intervention Thus, the proposed project will develop and test a novel behavioral intervention for opioid stigma in an effort to fill this unmet need. Together with her mentors, Principal Investigator Dr. Bulls will explore opioid stigma experiences and treatment priorities reported by a diverse group of 75 patients with advanced, painful cancer using rigorous concept mapping methodology (Aim 1). Next, Dr. Bulls will design a theory-based intervention to reduce negative proximal impacts of opioid stigma in patients with advanced cancer, soliciting feedback from patients and community-engaged resources prior to piloting (Aim 2). Finally, Dr. Bulls will conduct a pilot trial of the intervention with 45 patients with advanced cancer pain to evaluate feasibility and acceptability in preparation for a full-scale randomized controlled trial (Aim 3). This project will facilitate training crucial to Dr. Bulls' career development: advanced skills in participatory and stakeholder-engaged research methods, in-depth training in behavioral intervention development, and expertise in conducting clinical trials. Dr. Bulls has convened a dedicated, multidisciplinary 26 mentorship team with expertise in essential content and methodological areas including palliative oncology, 27 opioid pain management, health-related stigma, concept mapping, behavioral intervention development and 28 testing, and research in underserved groups, among others. This proposal represents a comprehensive training, 29 mentoring, and research plan to support Dr. Bulls' transition into a successful independent investigator. At the 30 end of the award period, Dr. Bulls will contribute substantially to the field as a leader in behavioral approaches to 31 improve opioid stigma in patients with advanced cancer. 32 33

摘要 中度至重度癌症疼痛在晚期癌症患者中很常见，通常可以通过处方阿片类药物有效治疗。有效的疼痛管理对于这些患者的最佳生活质量和健康结果至关重要。然而，美国阿片类药物危机的出现引发了人们对使用阿片类止痛药的广泛担忧，因为它可能会导致成瘾和服用过量等负面后果。尽管不受限制性阿片类药物政策的约束，但癌症患者在解决阿片类药物危机的努力中仍会遭受不良后果，包括与处方阿片类药物使用相关的耻辱（“阿片类药物耻辱”）。根据我们最近发布的阿片类药物耻辱框架，我们预计阿片类药物耻辱会导致一些近端（例如，患者与提供者沟通受损、健康行为不佳、情绪困扰、适应不良的应对技巧）和长期健康后果（例如，疼痛管理效果较差、健康相关生活质量下降）。新的证据表明，阿片类药物的耻辱是常见的、普遍的，并且有可能严重影响患者的健康。然而，尚无已知的干预措施可以减轻晚期癌症患者的阿片类药物耻辱感。此外，缺乏来自疼痛治疗不足高风险的服务不足社区（有色人种、农村地区的人和妇女）的观点，了解这些经验对于建立强有力的、包容性的阿片类药物耻辱干预措施至关重要。因此，拟议的项目将开发和测试一种针对阿片类药物耻辱的新型行为干预措施，以努力满足这一未满足的需求。首席研究员 Bulls 博士将与她的导师一起，使用严格的概念图方法（目标 1），探索由 75 名患有晚期、疼痛癌症的不同群体报告的阿片类药物耻辱经历和治疗重点。接下来，Bulls 博士将设计一种基于理论的干预措施，以减少阿片类药物耻辱对晚期癌症患者的负面近端影响，在试点之前征求患者和社区参与资源的反馈（目标 2）。最后，Bulls 博士将对 45 名晚期癌症疼痛患者进行干预试点试验，以评估可行性和可接受性，为全面随机对照试验（目标 3）做准备。该项目将促进对 Bulls 博士的职业发展至关重要的培训：参与式和利益相关者参与的研究方法的高级技能、行为干预开发的深入培训以及进行临床试验的专业知识。 Bulls 博士召集了一个专门的多学科团队 26 名导师团队在重要内容和方法领域拥有专业知识，包括姑息肿瘤学、 27 阿片类药物疼痛管理、与健康相关的耻辱、概念图、行为干预开发和 28 对服务不足的群体进行测试和研究等。该提案代表了全面的培训， 29 指导和研究计划，支持 Bulls 博士转变为成功的独立研究者。在 30 奖励期结束后，布尔斯博士将作为行为方法领域的领导者为该领域做出重大贡献 31 改善晚期癌症患者对阿片类药物的耻辱。 32 33