The development of a technology-based information support intervention (iSupport) among patients with differentiated thyroid cancer post radioactive iodine therapy

针对放射性碘治疗后分化型甲状腺癌患者开发基于技术的信息支持干预 (iSupport)

• 批准号: 10581121
• 负责人: Alaina L Carr
• 金额: $ 13.1万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-02 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10581121
• 关键词: Address; Adverse effects; Aftercare; Appointment; Behavior Therapy; Behavioral; Behavioral Model; Cancer Control; Cancer Patient; Caring; Cellular Phone; Clinical; Clinical Trials Design; Computers; Control Groups; Coping Skills; Data; Development; Devices; Diagnosis; Distress; Education; Educational Intervention; Eligibility Determination; Endocrine; Enrollment; European Organization for Research and Treatment of Cancer; Evidence based intervention; Feedback; Focus Groups; Follicular thyroid carcinoma; Frequencies; Frustration; Functional disorder; Future; Goals; Gold; Grant; Individual; Information Management; Intervention; Interview; Knowledge; Lacrimal gland structure; Late Effects; Leadership; Malignant Neoplasms; Malignant neoplasm of thyroid; Measures; Mentors; Mentorship; Nose; Online Systems; Oral health; Pain; Papillary Carcinoma; Participant; Patient Selection; Patient-Focused Outcomes; Patients; Persons; Phase; Population; Prognosis; Provider; Radioactive Iodine; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Research Design; Research Personnel; Salivary; Salivary Glands; Second Primary Cancers; Self Efficacy; Sleep; Social Functioning; Stress; Survival Rate; Symptoms; System; Technology; Testing; Training; Treatment Efficacy; Treatment Side Effects; Writing; acceptability and feasibility; alternative treatment; cancer therapy; cancer type; career development; common symptom; coping; design; digital health; digital technology; empowerment; experience; follow-up; health related quality of life; improved; intervention effect; lacrimal; novel; oral mucositis; patient population; pilot test; primary outcome; radioiodine therapy; reduce symptoms; secondary outcome; side effect; skills; social cognitive theory; support tools; survival outcome; survivorship; symptom management; symptom treatment; therapy design; therapy development; tool; treatment as usual; treatment comparison; treatment effect; understudied cancer; usability; web-based intervention

Abstract Radioactive iodine (RAI) therapy is routinely used among patients diagnosed with differentiated thyroid cancer (DTC), with approximately 76% of patients receiving RAI. Patients with DTC post RAI treatment report extensive short-term and late effects of treatment, symptom burden, and unmet informational needs about treatment related side effects. However, thyroid cancer is frequently referred to as the “good cancer” and is an understudied cancer population for survivorship research and web-based interventions. One way to address these gaps is through digital technologies such as a web-based intervention, which can empower patients with direct access to educational and support tools to reduce symptom burden. I propose to develop and evaluate a web-based intervention, called iSupport (informational support among patients post RAI treatment), to reduce symptom burden among patients diagnosed with DTC post RAI. I propose the following aims: Aim 1 (K99). Develop iSupport, a web-based intervention, for patients with DTC post RAI therapy. Aim 2 (K99). Test the usability of the newly developed iSupport intervention among patients with DTC post RAI. Aim 3 (R00). Assess the feasibility and acceptability of the iSupport intervention. Aim 4 (R00). Test the preliminary efficacy of the iSupport intervention vs. treatment as usual (TAU) among patients with DTC on symptom burden. The K99 phase will involve: 1) conducting patient focus groups (N=32) and individual stakeholder interviews (N=12) to develop iSupport and 2) testing the usability of the iSupport intervention among patients with DTC post RAI therapy (N=8). The R00 phase will involve conducting a pilot randomized controlled trial (RCT; N=72) to: 1) assess the feasibility and acceptability of iSupport and 2) test the preliminary efficacy of iSupport compared to a (TAU) control group with DTC patients on RAI-related symptom burden, patient bioheath indicators (oral mucositis; oral health problems), knowledge of DTC and RAI, self-efficacy for coping with side effects, cancer- related distress, and health-related quality of life. The overall objective of the K99/R00 is to provide Dr. Carr with training and mentorship to become an independent cancer control investigator with expertise in digital technology evidenced-based interventions among cancer patients. The K99 training goals include: 1) increase knowledge of clinical concerns and symptoms among patients with DTC post RAI, 2) obtain advanced training in technology-based intervention design and development, 3) develop expertise in behavioral intervention clinical trials design and testing, and 4) refine grant writing and leadership skills for future independence. Dr. Carr’s mentorship team includes Drs. Kristi Graves (primary), Jacqueline Jonklaas (co-mentor), and Kristen Miller (co-mentor) who are committed to her career development. The proposed training plan will facilitate Dr. Carr’s transition to independence as a cancer control researcher with expertise in digital health interventions to reduce symptom burden and improve health-related quality of life in cancer patient outcomes after treatment.

摘要 放射性碘(RAI)治疗是诊断为分化型甲状腺癌患者的常规治疗方法。 (DTC)，大约76%的患者接受RAI。RAI治疗后DTC患者报告 治疗的广泛短期和晚期影响、症状负担和未得到满足的信息需求 与治疗相关的副作用。然而，甲状腺癌通常被称为“良癌”，是一种 未充分研究癌症人群的生存研究和基于网络的干预。一种解决问题的方法 这些差距是通过数字技术实现的，例如基于网络的干预，它可以赋予患者 直接访问教育和支持工具，以减轻症状负担。我建议开发和评估一个 基于网络的干预，称为iSupport(RAI治疗后患者的信息支持)，以减少 RAI后诊断为DTC的患者的症状负担。我提出以下目标：目标1(K99)。 为RAI治疗后DTC患者开发iSupport，这是一种基于网络的干预措施。目标2(K99)。测试 新开发的iSupport干预在RAI后DTC患者中的可用性。目标3(R00)。 评估iSupport干预的可行性和可接受性。目标4(R00)。初步药效试验 在DTC患者的症状负担方面，iSupport干预与常规治疗(TAU)的比较。这个 K99阶段将包括：1)开展患者焦点小组(N=32)和个人利益相关者访谈(N=12) 开发iSupport和2)测试iSupport在RAI后DTC患者中的可用性 治疗组(N=8)。R00阶段将包括进行试点随机对照试验(RCT；N=72)至：1) 评估iSupport的可行性和可接受性，以及2)测试iSupport与 A组(TAU)为对照组，对DTC患者RAI相关症状负荷、患者生物健康指标(口服 粘膜炎；口腔健康问题)，DTC和RAI的知识，应对副作用的自我效能，癌症- 相关的痛苦和与健康相关的生活质量。K99/R00的总体目标是为Carr博士提供 通过培训和指导，成为拥有数字专业知识的独立癌症控制调查员 在癌症患者中进行以技术为基础的干预。K99培训目标包括：1)增加 对RAI后DTC患者的临床关注和症状的知识，2)接受高级培训 在基于技术的干预设计和开发中，3)开发行为干预方面的专业知识 临床试验设计和测试，以及4)完善未来独立性的拨款撰写和领导技能。Dr。 卡尔的导师团队包括Kristi Graves博士(主要导师)、Jacqueline Jonklaas博士(共同导师)和Kristen 米勒(共同导师)致力于她的职业发展。拟议的培训计划将为Dr。 作为一名癌症控制研究人员，卡尔过渡到独立，拥有数字健康干预方面的专业知识 减轻癌症患者治疗后症状负担，提高与健康相关的生活质量。