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多名青少年和年轻人（AYA）15至29岁 美国。 AYA更有可能出现晚期疾病和更具侵略性的肿瘤，并且 与年轻和年龄较大的癌症患者相比，预后较差。患有晚期癌症的AYA是 还受到高心理（例如焦虑，抑郁）和身体（例如疼痛）症状负担的挑战。 尽管如此，患有晚期癌症的AYA在姑息治疗中仍服务不足。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，大多数社会心理症状管理 在年龄> 40岁的个体中已经测试了干预措施。小儿姑息治疗也仍然存在差距 对于AYA患者，服务通常集中在年龄<15岁的患者的需求上。 AYA被诊断出 在关键的发展时期，他们正在努力实现与年龄相关的复杂目标（例如， 完成他们的教育，实现自主权，建立职业，建立人际关系，建立 家庭）。身体症状，心理困扰和实现挑战的结合 发展里程碑可能会加剧患者的痛苦；然而，AYA与年龄相关的独特需求 晚期癌症常常无法识别。拟议的项目将开始填补这一空白。该研究旨在 设计和测试设计的社会心理症状管理干预的可行性和可接受性 为了满足AYA与晚期癌症的独特需求。拟议的干预将结合传统 行为症状管理策略通常在姑息治疗环境中使用重要技能和 以意义为中心的心理治疗以及接受和承诺疗法的概念。这些技能 方法可能与患有晚期癌症的AYA尤其相关，他们在 癌症和相关症状的生活目标，可能会有更大的理解和发现 与年龄较小的患者相比，他们的生活意义。干预内容，结构和研究程序将 可以通过患者（n = 16）和护理人员（n = 12）的焦点组中获得的定性数据告知 利益相关者以及患者用户测试人员的审查（n = 3）。预计干预将包括四个 每周的课程超过6-8周，并使用视频会议进行。接下来，AYAS高级 癌症（n = 40）将使用1.5的分配比率随机分配到干预或教育控制臂上： 1。我们将研究研究招聘和保留率，可接受性以及变量变化的可行性 兴趣（即身体和心理症状，症状干扰，症状的自我效能 随着时间的流逝，干预和控制臂的管理，避免体验式，价值）。参与者会 还提供有关研究材料，干预格式的反馈以及对干预的适当性 人口和疾病的晚期阶段。从本试验研究获得的信息将使PI和 调查团队检查开发干预措施在更大的随机对照试验中的功效。