A Randomized Controlled Trial using a Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults with Cancer

使用启发式工具改善青少年和年轻人癌症患者症状自我管理的随机对照试验

• 批准号: 10563510
• 负责人: Suzanne W Ameringer
• 金额: $ 69.41万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-09 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10563510
• 关键词: Address; Adolescent and Young Adult; Adolescent and young adult cancer patients; Affect; Age; Asthma; Awareness; Behavior; Chronic Disease; Clinical; Collaborations; Communication; Conscious; Data; Decision Making; Diabetes Mellitus; Diagnosis; Disease; Distress; Economics; Education; Electronic Health Record; Fatigue; Gender; Goals; Health Personnel; Image; Individual; Informal Social Control; Intervention; Malignant Neoplasms; Modeling; Nausea; Outcome; Outcome Study; Outcomes Research; Patients; Population; Problem Solving; Process; Psyche structure; Quality of life; Race; Randomized; Randomized, Controlled Trials; Research; Research Priority; Resources; Role; Self Efficacy; Self Management; Self Perception; Severities; Site; Social Functioning; Social isolation; Symptoms; Tablet Computer; Testing; Time; Unconscious State; Underserved Population; United States; Visit; Visualization; Work; acceptability and feasibility; active method; cancer diagnosis; cancer therapy; chemotherapy; clinical care; common symptom; comparative efficacy; computerized; contextual factors; coping; cost; design; effective intervention; experience; follow-up; group intervention; health care quality; heuristics; improved; innovation; insight; person centered; pilot test; post intervention; primary outcome; provider communication; reduce symptoms; satisfaction; secondary outcome; skills; social health determinants; symptom management; symptom self management; symptomatic improvement; therapy design; tool; treatment as usual; trial design; usual care arm

PROJECT SUMMARY Approximately 90,000 adolescents and young adults (AYAs) are diagnosed with cancer yearly in the United States. AYAs with cancer experience multiple co-occurring and related symptoms from their disease and treatment that adversely affect their day-to-day lives and are difficult to self-manage. Because undermanaged symptoms reduce quality of life and increase symptom severity and distress, effective person-centered symptom self-management (SS-M) is imperative for AYAs with cancer. A major barrier, however, is a lack of effective symptom self-management interventions that are tailored to this population. The proposed study addresses this gap by testing an intervention designed to improve SS-M behaviors in AYAs with cancer who are in active treatment. The Computerized Symptom Capture Tool (C-SCAT) is an intervention that uses a heuristics approach to promote AYAs’ self-awareness and insight about themselves and their symptoms and help them visualize the ‘big picture’ of their unique symptom experience. This use of heuristics contrasts with typical checklist approaches to symptom assessment which do not incorporate the patient’s perspective to identify symptoms of high priority, defined as the symptoms that are most important to them, and interrelationships among symptoms. The C-SCAT also facilitates AYAs in discussing the symptom issues that are of greatest importance to them with a clinician and jointly developing an effective plan for SS-M. This study is a two-group multi-site randomized controlled trial in which 126 AYAs with cancer in active treatment will be randomly assigned to the C-SCAT intervention group or usual care control group. The specific aims are to: 1) Determine the effects of the C-SCAT versus usual care on the primary outcomes of self-efficacy for symptom management and symptom self-management behaviors immediately post intervention (Time 1) and at follow- up one month later (Time 2); 2) Examine the effects of the C-SCAT versus usual care on secondary outcomes (symptom severity, symptom distress, social function, and satisfaction with social function) immediately post intervention (Time 1) and at follow-up one month later (Time 2); and 3) Explore the relationships of individual factors and social determinants of health with self-efficacy for symptom management and symptom self- management behaviors at baseline (Time 0).The long-term goal of this research is to mitigate the symptoms that AYAs experience during cancer treatment by supporting symptom self-management. If shown to be effective, the C-SCAT could be incorporated into clinical settings and possibly into the electronic health record as an efficient, low-cost approach to improve symptom self-management.

项目概要 在美国，每年约有 90,000 名青少年和年轻人 (AYA) 被诊断患有癌症 国家。患有癌症的 AYA 会经历多种与其疾病相关的并发症状和症状 对他们的日常生活产生不利影响且难以自我管理的治疗。因为管理不善 症状降低生活质量并增加症状严重程度和痛苦，有效以人为本 对于患有癌症的 AYA 来说，症状自我管理 (SS-M) 势在必行。然而，一个主要障碍是缺乏 针对该人群的有效症状自我管理干预措施。拟议的研究 通过测试旨在改善患有癌症的 AYA 的 SS-M 行为的干预措施来解决这一差距 正在积极治疗中。计算机化症状捕获工具 (C-SCAT) 是一种使用 启发式方法，以促进 AYA 的自我意识和对自己及其症状的洞察力， 帮助他们想象自己独特症状经历的“大局”。这种启发法的使用与 典型的症状评估清单方法没有纳入患者的观点 识别高优先级症状，定义为对他们来说最重要的症状，以及 症状之间的相互关系。 C-SCAT 还促进 AYA 讨论以下症状问题： 对他们来说最重要的是与临床医生共同制定有效的 SS-M 计划。这项研究 是一项两组多中心随机对照试验，其中 126 名接受积极治疗的癌症 AYA 将被 随机分配到 C-SCAT 干预组或常规护理对照组。具体目标是：1） 确定 C-SCAT 与常规护理对症状自我效能主要结果的影响 干预后（时间 1）和随后的管理和症状自我管理行为 一个月后（时间2）； 2) 检查 C-SCAT 与常规护理对次要结果的影响 （症状严重程度、症状困扰、社会功能和社会功能满意度）立即发布 干预（时间 1）和一个月后的随访（时间 2）； 3）探索个体之间的关系 健康因素和社会决定因素以及症状管理和症状自我效能的自我效能 基线（时间 0）的管理行为。这项研究的长期目标是减轻症状 AYA 在癌症治疗期间通过支持症状自我管理所经历的体验。如果显示为 有效，C-SCAT 可以纳入临床环境，并可能纳入电子健康记录 作为改善症状自我管理的有效、低成本方法。