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: 9077663
• 负责人: KRISTI D. GRAVES
• 金额: $ 19.44万
• 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 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9077663
• 关键词: Adverse effects; Age; Altered Taste; Amylases; Behavioral Sciences; Biometry; Cancer Patient; Cancer Survivor; Categories; Characteristics; Clinical; Clinical Research; Cohort Studies; Conjunctivitis; Data; Dental caries; Development; Diagnostic Neoplasm Staging; 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; 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; base; cognitive testing; craniofacial; design; experience; eye dryness; functional outcomes; health related quality of life; high risk; improved; instrument; irritation; lacrimal; men; prevent; prospective; public health relevance; radioiodine therapy; response; sex; social; 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（由申请人提供）：甲状腺癌是美国增长最快的癌症，女性的年增长率为4.5%，男性为5.3%。放射性碘可以有效治疗高危甲状腺癌，从而提高生存率并降低复发率。甲状腺癌的成功治疗导致越来越多的甲状腺癌幸存者，其中许多人是年轻人。然而，除了破坏甲状腺癌，放射性碘还会损害唾液组织，引起不适和肿胀，反复发生唾液感染，味觉能力下降， 咀嚼干燥食物困难、唾液腺结石和龋齿增加。这些副作用会对生活质量产生负面影响。尽管认识到唾液腺症状，风险因素和唾液腺功能的相关性了解较少，代表知识空白。最近，RAI治疗的额外颅面后果已被认识到。流泪症状包括眼睛干涩、溢泪和结膜炎。鼻症状包括鼻刺激、鼻干燥和鼻出血。泪管和鼻损伤的真实发生率和后果尚不清楚。在我们能够开发技术以最小化RAI相关的发病率之前，测量颅面副作用的范围和影响是必不可少的。我们将开发和评估患者报告的问卷调查唾液，泪腺和鼻腔症状的分化型甲状腺癌患者谁是放射性碘治疗。我们将使用混合方法的方法，通过两个相互关联的研究阶段来开发问卷（称为SALANS）。在第一阶段，我们将对48名接受放射性碘治疗的甲状腺癌患者进行焦点小组研究，以确定颅面症状，并了解这些症状如何影响患者的生活质量。在对项目进行定性分析和专家评审后，我们将对16名患者进行新设计的SALANS问卷的认知测试。修订后，我们将对80例甲状腺癌患者（n=50例接受放射性碘治疗; n=30例未接受放射性碘治疗）进行SALANS问卷的初步测试，以建立维度和结构效度和判别效度。在第二阶段，我们将对50例新诊断为分化型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前和治疗后7天和3、6、9和12个月进行评估。我们将SALANS评分与使用唾液流量、进行唾液腺造影和测量血清唾液淀粉酶的唾液功能客观测量相关联。本研究的长期目标是提供一个有效和可靠的问卷，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伤。