Improving Symptom Management for Adolescents and Young Adults with Advanced Cancer: Development and Pilot Testing of a Novel Intervention

改善晚期癌症青少年和年轻人的症状管理：新型干预措施的开发和试点测试

• 批准号: 10527066
• 负责人: Caroline Dorfman
• 金额: $ 41.4万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10527066
• 关键词: Address; Adolescent and Young Adult; Adult; Advanced Malignant Neoplasm; Age; Anxiety; Area; Behavior; Behavioral Symptoms; Cancer Patient; Caregivers; Caring; Childhood; Complex; Coping Skills; Data; Development; Diagnosis; Disease; Distress; Education; Elderly; Family; Fatigue; Feasibility Studies; Feedback; Focus Groups; Fostering; Future; Goals; Incidence; Individual; Institutes; Intervention; Life; Malignant Neoplasms; Mental Depression; Morbidity - disease rate; Oncology; Outcome; Pain; Palliative Care; Parents; Participant; Patients; Pattern; Personal Satisfaction; Pilot Projects; Population; Positioning Attribute; Procedures; Prognosis; Provider; Psychotherapy; Quality of life; Randomized; Randomized Controlled Trials; Relationship-Building; Relaxation Therapy; Reporting; Research; Self Efficacy; Services; Severities; Structure; Symptoms; Techniques; Testing; Thinking; Time; Treatment Efficacy; United States; Value of Life; Videoconferencing; Work; acceptability and feasibility; advanced disease; age group; age related; aged; arm; associated symptom; care systems; career; critical developmental period; efficacy evaluation; emotional distress; emotional experience; experience; family building; feasibility testing; flexibility; improved; interest; mortality; novel; pain symptom; participant retention; peer; physical symptom; pilot test; pilot trial; primary care services; psychologic; psychological distress; psychological symptom; psychosocial; recruit; reduce symptoms; skills; symptom management; symptomatic improvement; therapy design; therapy development; treatment arm; tumor

Each year more than 30,000 adolescents and young adults (AYAs) aged 15 to 29 are diagnosed with cancer in the United States. AYAs are more likely to present with advanced disease and more aggressive tumors, and have worse prognosis when compared with younger and older cancer patients. AYAs with advanced cancer are also challenged by high psychological (e.g., anxiety, depression) and physical (e.g., pain) symptom burden. Despite this, AYAs with advanced cancer are underserved in palliative care. Adult palliative care services primarily treat older cancer patients (mean age 60-65); thus, the majority of psychosocial symptom management interventions have been tested among individuals aged >40. There too remains a gap in pediatric palliative care for AYA patients where services are typically focused on the needs of patients aged <15. AYAs are diagnosed during a critical developmental period when they are working to achieve complex, age-related goals (e.g., completing their educations, achieving autonomy, building their careers, fostering relationships, building families). The combination of physical symptoms, psychological distress, and challenges to achieving developmental milestones may exacerbate patient suffering; yet, the unique, age-related needs of AYAs with advanced cancer often go unrecognized. The proposed project will begin to fill this gap. The study aims to develop and test the feasibility and acceptability of a psychosocial symptom management intervention designed to meet the unique needs of AYAs with advanced cancer. The proposed intervention will combine traditional behavioral symptom management strategies commonly use in the palliative care setting with important skills and concepts from Meaning-Centered Psychotherapy and Acceptance and Commitment Therapy. Skills from these approaches may be particularly relevant to AYAs with advanced cancer who experience significant disruption in life goals from cancer and associated symptoms and may have greater difficulties understanding and finding meaning in their lives than older and younger patients. Intervention content, structure, and study procedures will be informed by qualitative data obtained during focus groups with patient (n=16) and caregiver (n=12) stakeholders as well as review by patient user testers (n=3). It is anticipated that the intervention will include four weekly sessions spaced over 6-8 weeks and be delivered using videoconferencing. Next, AYAs with advanced cancer (N=40) will be randomized to the intervention or education control arms using an allocation ratio of 1.5: 1. We will examine the feasibility of study recruitment and retention, acceptability, and changes in variables of interest (i.e., physical and psychological symptoms, symptom interference, self-efficacy for symptom management, experiential avoidance, values) over time for the intervention and control arms. Participants will also provide feedback on study materials, intervention format, and the appropriateness of the intervention to the population and advanced stage of disease. Information obtained from this pilot study will well position the PI and investigative team to examine the efficacy of the developed intervention in a larger randomized controlled trial.

每年有30,000多名15岁至29岁的青少年和年轻人被诊断出患有癌症 美国。AYA更有可能出现晚期疾病和更具侵袭性的肿瘤，以及 与年轻和年长的癌症患者相比，预后更差。患有晚期癌症的阿亚斯是 还受到高心理(如焦虑、抑郁)和身体(如疼痛)症状负担的挑战。 尽管如此，患有晚期癌症的AYA在姑息治疗方面得不到足够的服务。成人姑息治疗服务 主要治疗老年癌症患者(平均年龄60-65岁)；因此，大多数心理社会症状管理 干预措施已经在40岁的人群中进行了测试。在儿科姑息治疗方面也仍然存在差距 对于服务通常集中于15岁患者需求的AYA患者。AYA被诊断为 在他们努力实现复杂的、与年龄相关的目标的关键发展时期(例如， 完成学业，实现自主，建立事业，培养关系，建立 家庭)。身体症状、心理痛苦和实现目标的挑战相结合 发育里程碑可能会加剧患者的痛苦；然而，AYAS与年龄相关的独特需求 晚期癌症往往得不到治疗。拟议中的项目将开始填补这一空白。这项研究旨在 开发和测试设计的心理社会症状管理干预的可行性和可接受性 以满足AYA晚期癌症患者的独特需求。拟议的干预措施将结合传统的 行为症状管理策略通常用于姑息治疗环境中，具有重要的技能和 以意义为中心的心理治疗和接受与承诺治疗的概念。来自这些方面的技能 对于患有晚期癌症的AYA来说，这种方法可能特别相关，他们在 生活目标来自癌症和相关症状，可能会有更大的困难理解和查找 这意味着在他们的生活中比年龄更大和更年轻的患者。干预内容、结构和研究程序将 通过与患者(n=16)和护理者(n=12)的焦点小组期间获得的定性数据来了解情况 利益相关者以及患者用户测试员的审查(n=3)。预计此次干预将包括四项 每周会议间隔6-8周，并使用视频会议进行授课。接下来，AYAS与高级 癌症(N=40)将被随机分配到干预组或教育控制组，分配比例为1.5： 1.我们会研究学生招聘和保留的可行性、可接受性，以及变量的变化 兴趣(即生理和心理症状、症状干扰、症状自我效能 管理，经验回避，价值观)随着时间的推移而进行干预和控制。参与者将 还提供关于研究材料、干预形式和干预适当性的反馈 人口和疾病晚期。从这项初步研究中获得的信息将很好地定位PI和 研究小组在一项更大的随机对照试验中检查开发的干预措施的有效性。