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

摘要中重度癌痛在晚期癌症患者中很常见，处方阿片类药物往往能有效地治疗这种疼痛。有效的疼痛管理对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阿片类止痛药使用的广泛担忧，因为它可能会产生成瘾和过量等负面后果。尽管免除了限制性阿片类药物政策，癌症患者仍会经历解决阿片类药物危机的努力的不良后果，包括与处方阿片类药物使用有关的耻辱(“阿片类药物耻辱”)。根据我们最近发表的阿片污名框架，我们预计阿片污名会导致几种近期的(例如，患者与提供者的沟通受损、健康行为不佳、情绪困扰、适应不良的应对技能)和长期的健康后果(例如，疼痛管理效果降低，与健康相关的生活质量下降)。新出现的证据表明，阿片类药物污名是常见的、普遍的，并有可能严重影响患者的福祉。然而，目前还没有已知的干预措施来减轻晚期癌症患者的阿片类药物耻辱。此外，缺乏来自服务不足的高风险疼痛治疗社区-有色人种、农村地区的人和妇女-的视角，了解这些经历对于建立强有力的、包容性的阿片污名干预至关重要。因此，拟议的项目将开发和测试一种新的阿片污名行为干预措施，以努力满足这一未得到满足的需求。首席研究员布尔斯博士将与她的导师一起，使用严格的概念图方法(目标1)探索阿片类药物耻辱的经历和由75名晚期疼痛癌症患者组成的不同群体报告的治疗重点。接下来，布尔斯博士将设计一项基于理论的干预措施，以减少阿片类药物污名对晚期癌症患者的近期负面影响，在试点之前征求患者和社区参与资源的反馈(目标2)。最后，布尔斯博士将对45名晚期癌症疼痛患者进行干预的试点试验，以评估为全面随机对照试验(AIM 3)做准备的可行性和可接受性。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方面的高级技能，行为干预开发的深入培训，以及进行临床试验的专业知识。布尔斯博士召集了一个专门的、多学科的 26个在基本内容和方法领域(包括姑息治疗肿瘤学)具有专业知识的指导团队， 27阿片类疼痛管理、与健康相关的污名、概念图、行为干预发展和 28在服务不足的群体中进行测试和研究等。这项建议代表了一种全面的培训， 29指导和研究计划，以支持布尔斯博士转变为一名成功的独立调查员。在 30在获奖期结束时，布尔斯博士将作为行为方法的领导者为该领域做出重大贡献 31改善晚期癌症患者的阿片污名。 32 33