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: 10016233
• 负责人: Caroline Dorfman
• 金额: $ 17.2万
• 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/10016233
• 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 environment; 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; Waiting Lists; Weight maintenance regimen; Work; aged; arm; base; cancer cell; cancer therapy; cancer type; career; emotional distress; evidence base; experience; follow-up; improved; 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.

在美国，每年有超过 60,000 名 18-39 岁的年轻人 (YA) 被诊断患有癌症。进展 治疗的五年生存率>70%，这表明大多数 YA 将成为长期患者 癌症幸存者。症状（例如疼痛、疲劳、痛苦）干扰对于 YA 癌症幸存者来说很常见 影响他们实现正常生活目标的能力（例如重返工作/学校、实现自主、 追求社交/浪漫关系）并遵守建议的后续护理。症状管理有 被医学研究所认为是青少年向生存过渡的一个重要问题 美国国家癌症研究所，症状管理援助被评为重要且未满足的需求 由YA幸存者撰写。然而，行为症状管理干预措施并未针对这些人的需求 诊断为 YA。拟议的研究旨在开发和测试新颖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：血液学、 乳腺癌或胃肠道癌症、黑色素瘤或生殖细胞肿瘤）。混合干预措施将包括： 个人、小组会议和集成的移动应用程序。干预措施将提供同伴支持，同时 还教授改善症状、症状干扰和症状管理自我效能的技能。 该移动应用程序将协助症状监测、家庭技能练习以及与团体联系 成员。干预措施的初步版本将以研究团队之前开发的工作为指导 并测试癌症幸存者的症状管理干预措施、国家青少年肿瘤学指南、 咨询专家咨询委员会，并听取患者（3 组，n=10/组）和提供者（1 组， N=10) 在焦点小组中获得的利益相关者。经审查后，干预措施将进一步完善 患者用户测试员 (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一项试点随机临床试验进行检查 制定了干预措施。参与者 (N=60) 将被随机分配到干预组或等待名单对照组。基本的 研究结果是症状（疼痛、疲劳、痛苦）的严重程度和症状干扰。自我效能感和 支持也将被视为结果变量变化的中介因素。拟议的研究有潜力 通过针对服务不足的癌症幸存者群体做出多项重大贡献，解决 护理方面的重大差距，并解决与青少年学生的社会、经济和健康负担始终相关的变量。 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增强 PI 的能力 有能力成为一名独立研究者，开发、评估和传播青少年青少年干预措施 癌症幸存者：1) 临床试验设计和统计方法，2) 使用移动医疗技术进行研究和 干预措施的实施，3) 诊断为 YA 的癌症幸存者的需求，以及 4) 专业发展。