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.

每年有超过 30,000 名 15 至 29 岁的青少年和年轻人 (AYA) 被诊断患有癌症 美国。 AYA 更有可能出现晚期疾病和更具侵袭性的肿瘤，并且 与年轻和老年癌症患者相比，预后较差。患有晚期癌症的 AYA 是 还面临着较高的心理（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 仍得不到姑息治疗服务。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 干预措施已在 40 岁以上的个体中进行了测试。儿科姑息治疗也仍存在差距 针对 AYA 患者，服务通常侧重于 15 岁以下患者的需求。 AYA 被确诊 在关键的发展时期，他们正在努力实现复杂的、与年龄相关的目标（例如， 完成教育、实现自主、建立职业生涯、培养人际关系、建立 家庭）。身体症状、心理困扰和实现目标的挑战的结合 发育里程碑可能会加剧患者的痛苦；然而，AYA 的独特的、与年龄相关的需求 晚期癌症常常未被识别。拟议的项目将开始填补这一空白。该研究旨在 开发并测试所设计的心理社会症状管理干预措施的可行性和可接受性 满足患有晚期癌症的 AYA 的独特需求。拟议的干预措施将结合传统的 姑息治疗环境中常用的行为症状管理策略具有重要的技能和 来自以意义为中心的心理治疗和接受与承诺治疗的概念。技能来自于这些 方法可能与患有晚期癌症的 AYA 特别相关，他们的生活经历了严重的破坏。 癌症和相关症状的生活目标可能会更难理解和找到 与年老和年轻的患者相比，他们的生活意义重大。干预内容、结构和研究程序将 通过与患者 (n=16) 和护理人员 (n=12) 进行焦点小组讨论时获得的定性数据来了解信息 利益相关者以及患者用户测试人员的审查（n=3）。预计干预措施将包括四项 每周会议间隔 6-8 周，并通过视频会议进行。接下来，具有高级功能的 AYA 癌症 (N=40) 将使用 1.5 的分配比率随机分配到干预组或教育对照组： 1. 我们将审查研究招募和保留的可行性、可接受性以及变量的变化 兴趣（即身体和心理症状、症状干扰、症状的自我效能） 随着时间的推移，干预组和控制组的管理、经验性回避、价值观）。参与者将 还提供有关学习材料、干预形式以及干预对目标的适当性的反馈 人群和疾病晚期。从这项试点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所开发的干预措施的有效性。