Improving Symptom Management for Survivors of Young Adult Cancer

在美国，每年有超过60，000名18-39岁的年轻人（YAs）被诊断患有癌症。进展 治疗产生了>70%的五年生存率，这表明大多数YA将成为长期的 癌症幸存者症状（例如，疼痛，疲劳，痛苦）干扰是常见的YA癌症幸存者， 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， 追求社会/浪漫关系），并坚持建议的后续护理。症状管理 被确定为一个重要的问题，在过渡到生存的YAs由医学研究所和 国家癌症研究所，并协助症状管理被评为一个重要的和未满足的需求 幸存者们。然而，行为症状管理干预措施并没有针对那些 被诊断为雅。这项研究旨在开发和测试一部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（癌症类型：血液学， 乳腺癌或胃肠癌、黑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的应用程序。干预措施将提供同伴支持， 还教授改善症状、症状干预和症状管理的自我效能的技能。 移动的应用程序将协助症状监测、家庭技能练习和与小组联系 成员干预措施的初步版本将以研究小组先前的工作为指导， 和测试癌症幸存者的症状管理干预措施，国家YA肿瘤学指南， 咨询专家咨询委员会，以及患者（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相关者。在审查后，将进一步完善干预措施， 患者用户测试者（n=10）。其次，可行性，可接受性，以及随时间变化的分布， 结果变量之间的关系将通过一项试验性随机临床试验进行检查， 发展干预。受试者（N=60）将被随机分配至干预组或等待名单对照组。初级 研究结果是症状（疼痛、疲劳、痛苦）严重程度和症状干扰。自我效能感与 还将审查支助作为结果变量变化的媒介。这项研究有可能 通过针对得不到充分服务的癌症幸存者群体， 关键差距的护理，并解决变量始终与社会，经济和健康负担的青年。 它还将提供有关方法的重要信息，以确定，招募和保留YA癌症幸存者， 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 有能力成为一名独立的调查员，为YA开发，评估和传播干预措施 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， 干预交付，3）诊断为YAs的癌症幸存者的需求，以及4）专业发展。

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.