Improving Symptom Management for Survivors of Young Adult Cancer

改善年轻成人癌症幸存者的症状管理

• 批准号: 10474989
• 负责人: Caroline Dorfman
• 金额: $ 17.16万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-11 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10474989
• 关键词: Achievement; Address; Aftercare; Area; Award; Behavior; Behavioral; Behavioral Symptoms; Breast Cancer survivor; Cancer Intervention; Cancer Survivor; Caring; Clinical; Clinical Trials Design; Cognitive; Consultations; Coping Skills; Data; Development; Diagnosis; Diet; Distress; Economics; Education; Educational process of instructing; Fatigue; Focus Groups; Funding; Germ cell tumor; Goals; Guidelines; Health; Healthcare; Hematologic Neoplasms; Home; Hybrids; Institute of Medicine (U.S.); Institutes; Intervention; Late Effects; Lead; Life; Link; Long-Term Effects; Malignant Neoplasms; Malignant neoplasm of gastrointestinal tract; Mediating; Mediator of activation protein; Melanoma Cell; Mentors; Monitor; National Cancer Institute; Notification; Oncology; Outcome; Outcome Study; Pain; Participant; Patient Outcomes Assessments; Patients; Pattern; Personal Satisfaction; Persons; Physical activity; Provider; Psychologist; Randomized; Randomized Clinical Trials; Research; Research Design; Research Personnel; Resources; Schools; Self Efficacy; Severities; Statistical Methods; Structure; Survival Rate; Survivors; Symptoms; Technology; Teenagers; Testing; Time; Training; Underserved Population; Waiting Lists; Weight maintenance regimen; Work; acceptability and feasibility; aged; arm; base; cancer cell; cancer therapy; cancer type; career; emotional distress; evidence base; experience; feasibility testing; follow-up; improved; intervention delivery; mHealth; malignant breast neoplasm; member; mobile application; novel; oncology program; peer; peer support; physical symptom; pilot trial; prevent; programs; prototype; psychological symptom; recruit; skills; skills training; social; social cognitive theory; social relationships; survivorship; symptom management; symptomatic improvement; therapy design; treatment arm; young adult

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.

每年美国，有60,000多名18-39岁的年轻人（YAS）被诊断出患有癌症。进步 治疗已产生五年的生存率> 70％，这表明大多数YA将成为长期 癌症存活。症状（例如，疼痛，疲劳，困扰）干扰对于YA癌症存活和 影响他们实现正常生活目标的能力（例如，返回工作/学校，实现自治， 追求社会/浪漫关系）并坚持推荐的后续护理。症状管理具有 在医学研究所和 国家癌症研究所（National Cancer Institute）和症状管理协助被评为重要且未满足的需求 由YA表面。然而，行为症状管理干预措施并未针对那些的需求 被诊断为Yas。拟议的研究旨在发展和测试新颖的可行性和可接受性 为YA癌症生存而设计的行为症状管理干预措施（癌症类型：血液学， 乳腺癌或胃肠道癌，黑色素瘤或生殖细胞肿瘤）。混合干预将包括 人，小组会议和集成的移动应用程序。干预将提供同伴支持 还可以教授改善症状，症状管理的症状，干扰和自我效能感。 移动应用程序将有助于症状监测，家庭技能练习以及与小组的联系 成员。干预的初步版本将由研究团队先前的工作进行指导 以及测试癌症生存的SYM管理干预措施，国家肿瘤学指南， 与专家顾问委员会协商，并提供患者的意见（3组，n = 10/组）和提供商（1组， n = 10）在焦点小组中获得的利益相关者。在审查后，将进一步完善干预措施 患者用户测试人员（n = 10）。接下来，随着时间的推移，可行性，可接受性和变化的分布以及 结果变量之间的关系将通过试点的随机临床试验进行检查 发展干预。参与者（n = 60）将被随机分为干预或等待名单控制臂。基本的 研究结果是症状（疼痛，疲劳，遇险）严重程度和症状干扰。自我效能和 支持还将作为结果变量变化的介体进行检查。拟议的研究具有潜力 通过针对服务欠缺的癌症存活来做出一些重要的贡献，以解决 护理的临界差距以及解决与YA的社会，经济和健康烧伤的变量。 它还将提供有关识别，招募和保留YA癌症存活方法的重要信息 研究并为大型试验提供试验数据。以下领域的正式培训将加强PI的 能够成为开发，评估和传播YA干预措施的独立研究者 癌症存活：1）临床试验设计和统计方法，2）使用MHealth技术进行研究和 干预措施，3）诊断为YA的癌症存活需求，以及4）专业发展。