Improving Symptom Management for Survivors of Young Adult Cancer

在美国，每年有超过6万名18-39岁的年轻人被诊断出患有癌症。最新进展 治疗后的五年存活率为70%，这表明大多数YAS将成为长期的 癌症幸存者。症状(如疼痛、疲劳、痛苦)的干预对于YA癌症幸存者和 影响他们实现规范生活目标的能力(例如，重返工作/学校，实现自主性， 追求社交/浪漫关系)，并坚持建议的后续护理。症状管理有 被医学研究所确定为YAS向生存过渡过程中的一个重要问题 国家癌症研究所，症状管理方面的援助被认为是一项重要的未得到满足的需求 被YA幸存者。然而，行为症状管理干预并没有针对这些人的需求 被诊断为YAS。拟议的研究旨在开发和测试小说的可行性和可接受性 为YA癌症幸存者设计的行为症状管理干预措施(癌症类型：血液病， 乳腺癌、胃肠癌、黑色素瘤或生殖细胞肿瘤)。混合干预措施将包括- 个人、组会话和集成的移动应用程序。干预将提供同行支持，同时 还教授改善症状、症状干预和症状管理自我效能的技能。 移动应用程序将帮助进行症状监测、家庭技能练习以及与小组建立联系 会员。干预的初步版本将以研究团队之前开发的工作为指导 和针对癌症幸存者的症状管理干预测试，YA肿瘤学国家指南， 咨询专家咨询委员会，以及来自患者(3组，n=10/组)和提供者(1组， N=10)在焦点小组期间获得的利益攸关方。在经过审查后，将进一步完善干预措施 患者用户测试者(n=10)。接下来，更改的可行性、可接受性和随时间的分布 结果变量之间的关系将通过一项试点随机临床试验来检验 发达的干预措施。参与者(N=60)将被随机分配到干预或等待名单控制武器。主要 研究结果是症状(疼痛、疲劳、痛苦)严重程度和症状干预。自我效能感和 还将审查支持作为结果变量变化的调解人的情况。拟议中的研究具有潜在的 通过瞄准服务不足的癌症幸存者群体做出几项重大贡献，解决 护理方面的重大差距，并解决与雅加达人的社会、经济和健康负担持续相关的变量。 它还将提供有关识别、招募和留住YA癌症幸存者的方法的重要信息 研究并为更大规模的试验提供试点数据。以下领域的正式培训将加强PI的 有能力成为制定、评估和传播YA干预措施的独立调查员 癌症幸存者：1)临床试验设计和统计方法，2)使用mHealth技术进行研究和 3)确诊为YAS的癌症幸存者的需求；4)职业发展。

More than 60,000 young adults (YAs) aged 18-39 are diagnosed with cancer in the US each year. Advances in treatment have yielded five year survival rates >70% suggesting that the majority of YAs will become long-term cancer survivors. Symptom (e.g., pain, fatigue, distress) interference is common for YA cancer survivors and impacts their abilities to achieve normative life goals (e.g., returning to work/school, achieving autonomy, pursuing social/romantic relationships) and adhere to recommended follow-up care. Symptom management has been identified as a significant issue in the transition to survivorship for YAs by the Institute of Medicine and National Cancer Institute, and assistance with symptom management is rated as an important and unmet need by YA survivors. Yet, behavioral symptom management interventions have not targeted the needs of those diagnosed as YAs. The proposed study aims to develop and test the feasibility and acceptability of a novel behavioral symptom management intervention designed for survivors of YA cancer (cancer types: hematologic, breast, or gastrointestinal cancers, melanoma, or germ cell tumors). The hybrid intervention will include in- person, group sessions and an integrated mobile application. The intervention will provide peer support while also teaching skills to improve symptoms, symptom interference, and self-efficacy for symptom management. The mobile application will assist with symptom monitoring, home skills practice, and connecting with group members. The preliminary version of the intervention will be guided by the research team’s prior work developing and testing symptom management interventions for cancer survivors, national guidelines for YA oncology, consultation with an expert advisory board, and input from patient (3 groups, n=10/group) and provider (1 group, N=10) stakeholders obtained during focus groups. The intervention will be further refined following review by patient user testers (n=10). Next, feasibility, acceptability, and distributions of change over time as well as relationships between outcome variables will be examined through a pilot randomized clinical trial of the developed intervention. Participants (N=60) will be randomized to intervention or wait-list control arms. Primary study outcomes are symptom (pain, fatigue, distress) severity and symptom interference. Self-efficacy and support will also be examined as mediators of change in outcome variables. The proposed study has the potential to make several significant contributions by targeting an underserved group of cancer survivors, addressing a critical gap in care, and addressing variables consistently linked to social, economic, and health burden for YAs. It will also provide important information about approaches to identify, recruit, and retain YA cancer survivors in research and provide pilot data for a larger trial. Formal training in the following areas will strengthen the PI’s ability to become an independent investigator developing, evaluating, and disseminating interventions for YA cancer survivors: 1) clinical trial design and statistical methods, 2) use of mHealth technology for research and intervention delivery, 3) needs of cancer survivors diagnosed as YAs, and 4) professional development.