Capturing the Impact of Craniofacial Damage after Radioiodine Therapy

了解放射性碘治疗后颅面损伤的影响

• 批准号: 9900576
• 负责人: KRISTI D. GRAVES
• 金额: $ 35.48万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9900576
• 关键词: Age; Altered Taste; Amylases; Behavioral Sciences; Biometry; Cancer Patient; Cancer Survivor; Categories; Characteristics; Clinical; Clinical Research; Conjunctivitis; Data; Dental caries; Development; Dimensions; Disease; Distress; Dose; Dried Foods; Eating; Endocrinology; Epistaxis; Evaluation; Excretory function; Eye; Face; Female; Focus Groups; Frequencies; Future; Goals; Gold; Incidence; Individual; Infection; Inflammation; Knowledge; Lead; Link; Malignant Neoplasms; Malignant neoplasm of thyroid; Mastication; Measurement; Measures; Methods; Morbidity - disease rate; Newly Diagnosed; Nose; Outcome; Outcome Measure; Pain; Patients; Phase; Physicians; Preventive measure; Procedures; Prospective cohort study; Provider; Psychometrics; Quality of life; Questionnaires; Radioactive Iodine; Radionuclide Imaging; Recurrence; Reporting; Research; Risk; Risk Factors; Salivary; Salivary Glands; Serum; Sialolithiasis; Sleep; Social Functioning; Swelling; Symptoms; Taste Perception; Technetium 99m; Techniques; Testing; Time; Tissues; Uncertainty; United States; Woman; Work; Xerostomia; associated symptom; cognitive testing; craniofacial; design; experience; eye dryness; functional outcomes; health related quality of life; high risk; improved; instrument; irritation; lacrimal; men; multidisciplinary; prevent; prospective; public health relevance; radioiodine therapy; response; sex; side effect; social relationships; sound; survival outcome; symptom management; tool; uptake

 DESCRIPTION (provided by applicant): Thyroid cancer is the most rapidly increasing cancer in the United States, with an annual percentage increase of 4.5% in women and 5.3% in men. High-risk thyroid cancer can be effectively treated by radioactive iodine, which leads to improved survival and decreased recurrence rates. The successful treatment of thyroid cancer has lead to an ever-increasing number of thyroid cancer survivors, many of whom are young. However, in addition to destroying thyroid cancer, radioactive iodine also damages salivary tissue, causing discomfort and swelling, recurrent salivary infections, decreased ability to taste, difficulty chewing dry foods, salivary gland stones, and increased dental caries. These side effects negatively impact quality of life. Despite recognition of salivary symptoms, risk factors and correlation with salivary function are less understood and represent knowledge gaps. Recently, additional craniofacial consequences of RAI treatment have been recognized. Lacrimal symptoms include dry eyes, over-flowing tears, and conjunctivitis. Nasal symptoms include nasal irritation, dry nose, and nose bleeds. The true incidence and consequences of lacrimal and nasal damage are unknown. Measurement of the range and impact of craniofacial side effects is essential before we can develop techniques to minimize RAI-related morbidity. We will develop and evaluate a patient-reported questionnaire of salivary, lacrimal and nasal symptoms in patients with differentiated thyroid cancer who are treated with radioactive iodine. We will use a mixed methods approach to develop the questionnaire (called SALANS) through two linked phases of research. In Phase I, we will conduct focus groups with 48 patients with thyroid cancer treated with radioactive iodine to identify the craniofacial symptoms and understand how these symptoms impact patients' quality of life. Following qualitative analyses and expert review of items, we will conduct cognitive testing of the newly designed SALANS questionnaire in 16 patients. After revision, we will conduct a pilot test of the SALANS questionnaire with a group of 80 patients with thyroid cancer (n=50 treated with radioactive iodine; n=30 not treated with radioactive iodine) to establish dimensionality and construct and discriminant validity. In Phase II, we will conduct a prospective cohort study with 50 patients newly diagnosed with differentiated thyroid cancer who will receive radioactive iodine treatment. We will conduct assessments prior to and then 7-days and 3, 6, 9 and 12 months post radioactive iodine therapy. We will correlate SALANS scores with objective measures of salivary function using salivary flow, performing salivary scintigraphy, and measurement of serum salivary amylase. The long-term goal of this research is to provide a valid and reliable questionnaire that can serve as the underpinning for future studies to prevent or ameliorate craniofacial damage in patients receiving radioactive iodine therapy.

 描述（由适用提供）：甲状腺癌是美国癌症最快的癌症，女性的年百分比增加了4.5％，男性为5.3％。可以通过放射性碘有效治疗高风险的甲状腺癌，从而提高了生存率和复发率的提高。甲状腺癌的成功治疗导致了数量不断增加的甲状腺癌冲浪者，其中许多人年轻。但是，除了破坏甲状腺癌外，放射性碘还会损害唾液组织，导致不适和肿胀，复发性唾液感染，降低味道的能力，降低 难以咀嚼干食品，唾液腺结石和牙齿增加。这些副作用会对生活质量产生负面影响。尽管认识到唾液症状，但危险因素和与唾液功能的相关性较少，并且代表知识差距。最近，已经认识到RAI治疗的其他颅面后果。泪液症状包括干眼，泪水过度和结膜炎。鼻部症状包括鼻部刺激，干鼻和鼻子流血。泪和鼻损伤的真实事件和后果尚不清楚。在我们开发技术以最大程度地减少与RAI相关的发病率之前，必须测量颅面副作用的范围和影响。我们将在分化的甲状腺癌患者中开发和评估一份患者报告的唾液，泪和鼻腔症状的问卷，这些患者接受了放射性碘的治疗。我们将使用混合方法方法通过两个链接的研究阶段来开发问卷（称为salans）。在第一阶段，我们将与48例用放射性碘治疗的甲状腺癌患者进行焦点小组，以识别颅面症状，并了解这些症状如何影响患者的生活质量。经过定性分析和对项目的专家审查，我们将对新设计的16名患者进行新设计的Salans问卷进行认知测试。经过修订后，我们将对一组80例甲状腺癌患者（用放射性碘治疗的50例； n = 30未用放射性碘治疗），以建立维度和构建和歧视有效性。在第二阶段，我们将对50例新诊断为分化甲状腺癌的患者进行前瞻性队列研究，这些患者将接受放射性碘治疗。我们将在放射性碘治疗后7天和3、6、9和12个月之前进行评估。我们将使用唾液流，唾液闪烁显像和血清唾液淀粉酶测量的唾液功能与唾液功能的客观测量相关联。这项研究的长期目标是提供有效且可靠的问卷，该问卷可以作为未来研究的基础，以预防或改善接受放射性碘治疗的患者的颅面损害。