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， 美国的AYA更有可能出现晚期疾病和更具侵袭性的肿瘤， 与年轻和老年癌症患者相比，预后更差。患有晚期癌症的AYA 还受到高心理（例如，焦虑，抑郁）和身体（例如，疼痛）症状负担。 尽管如此，患有晚期癌症的AYA在姑息治疗方面服务不足。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，大多数心理社会症状管理 在40岁以上的人中测试了干预措施。儿科姑息治疗也存在差距 对于AYA患者，服务通常集中在15岁以下患者的需求上。AYA诊断 在关键的发展时期，当他们正在努力实现复杂的，与年龄相关的目标（例如， 完成他们的教育，实现自主权，建立他们的职业生涯，培养关系，建立 家庭）。身体症状、心理困扰和实现目标的挑战 发育里程碑可能会加剧患者的痛苦;然而，AYA的独特，与年龄相关的需求， 晚期癌症往往无法被发现。拟议的项目将开始填补这一空白。该研究旨在 开发和测试心理社会症状管理干预的可行性和可接受性， 以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联合收割机传统的 行为症状管理策略通常用于姑息治疗环境的重要技能， 意义中心心理治疗和接受与承诺治疗的概念。从这些技能 这种方法可能特别适用于患有晚期癌症的AYA，他们在治疗过程中受到了严重的破坏。 癌症和相关症状的生活目标，并可能有更大的困难理解和发现 对他们生命意义的影响。干预内容、结构和研究程序将 通过患者（n=16）和护理人员（n=12）焦点小组期间获得的定性数据了解情况 利益相关者以及患者用户测试人员的评审（n=3）。预计干预措施将包括四个 每周会议，间隔6-8周，并通过视频会议进行。下一篇：AYAs with Advanced 癌症患者（N=40）将被随机分配至干预或教育对照组，分配比例为1.5： 1.我们将检查研究招募和保留的可行性、可接受性以及 兴趣（即，身心症状，症状干预，症状自我效能感 管理，经验回避，价值观）随时间的干预和控制武器。参与者将 还提供关于学习材料、干预形式和干预对学生的适当性的反馈。 人口和疾病晚期。从该初步研究中获得的信息将很好地定位PI， 研究小组在一个更大的随机对照试验中检查开发的干预措施的有效性。