PILOT STUDY OF GERIATRIC ASSESSMENTS IN SENIOR ADULTS WITH MULTIPLE MYELOMA

患有多发性骨髓瘤的老年人老年评估的试点研究

• 批准号: 8518212
• 负责人: Tanya M Wildes
• 金额: $ 7.18万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8518212
• 关键词: Adult; Affect; Age; Aging; Attention; Autologous; Benefits and Risks; Blinded; Cancer Center; Caring; Chronic Disease; Clinical Trials; Cohort Studies; Comorbidity; Data; Decision Making; Dependence; Diagnosis; Disease; Disease Outcome; Dose; Effectiveness; Elderly; Enrollment; Epidemiologist; Future; Geriatric Assessment; Geriatrics; Goals; Hematology; Institutes; Intervention; Knowledge; Life; Malignant Neoplasms; Mission; Modeling; Multiple Myeloma; Newly Diagnosed; Oncologist; Outcome; Patients; Physicians; Pilot Projects; Positioning Attribute; Prevalence; Public Health; Quality of life; Reporting; Research; Research Project Grants; Risk; Risk Factors; Selection for Treatments; Site; Solid Neoplasm; Stem cell transplant; Syndrome; Therapeutic Agents; Time; Toxic effect; Toxicity due to chemotherapy; Training; Transplant Recipients; Universities; Walking; Washington; Work; cancer therapy; chemotherapy; cohort; comparative effectiveness; compare effectiveness; disability; disorder control; experience; falls; follow-up; functional decline; functional outcomes; functional status; hearing impairment; improved; innovation; instrumental activity of daily living; novel therapeutics; older patient; oncology; prospective; response; tool; treatment strategy

DESCRIPTION (provided by applicant): The number of older adults with multiple myeloma (MM) will double in the next two decades, yet there is a fundamental gap in knowledge of the impact of baseline geriatric syndromes on treatment selection, toxicity and outcomes in older adults with MM. No MM study to date has included comprehensive geriatric assessments or assessed the impact of therapy on geriatric domains over time. The long-term goals of this project are 1) to integrate geriatric assessments into the care of senior adults with MM so that clinicians may predict toxicity and functional decline due to MM therapy and 2) to facilitate decision-making for clinicians and patients by examining the real-world effectiveness of MM therapy in older adults. The objectives of this project are to compare the prevalence of geriatric syndromes in MM patients who receive high dose therapy/autologous stem cell transplant (HDT/ASCT) versus those who do not, and to identify which patients are vulnerable to decline in functional status. The central hypotheses are that patients with comorbidities or dependence in at least one IADL at baseline will be less likely to undergo intense therapy with HDT/ASCT and that patients with comorbidities will be more likely to develop disability in their IADLs after 6 months of followup. The rationale for the proposed research is that understanding the impact of baseline geriatric factors on treatment decisions and identifying which patients are at risk for functional decline will allow more personalized decision-making and targeted interventions for older MM patients at risk for decline. The objectives will be accomplished through two specific aims: 1) To explore the relationship between baseline geriatric assessments and initial treatment selection in older adults with newly diagnosed multiple myeloma; and 2) To determine whether baseline geriatric syndromes predict decline in functional status at 6 months of follow-up in older adults with newly diagnosed multiple myeloma. Aim 1 will be accomplished in an prospective pilot cohort study of 30 patients over the age of 65 with recently diagnosed MM seen at Siteman Cancer Center/ Washington University. Patients will complete the Cancer and Aging Research Group geriatric assessment tool; associations between baseline geriatric assessments and initial treatment strategy (HDT/ASCT vs nontransplant) will be evaluated. For Aim 2, the cohort enrolled in Aim 1 will undergo repeat geriatric assessments at 3 and 6-months of follow-up; risk factors for functional decline will be identified. The contribution of this propsed research is significant because it is the first step in a continuum of research expected to compare the effectiveness of HDT/ASCT to non-transplant treatment strategies both in terms of disease-control and the impact of therapy on quality of survival. The proposed research is innovative because it anticipates an impending paradigm shift wherein cancer is becoming a chronic illness, using MM as a model malignancy to study the interrelationships among geriatric syndromes, treatment selection, long-term toxicities of cancer treatment and survival.

描述（由申请人提供）：未来二十年，患有多发性骨髓瘤 (MM) 的老年人数量将增加一倍，但对于基线老年综合征对老年人治疗选择、毒性和结果的影响，人们的认识存在根本差距。大人MM。迄今为止，尚无 MM 研究包含全面的老年病评估或评估治疗随时间推移对老年病领域的影响。该项目的长期目标是 1) 将老年评估纳入患有 MM 的老年患者的护理中，以便临床医生可以预测 MM 治疗引起的毒性和功能衰退，2) 通过检查来促进临床医生和患者的决策MM 治疗在老年人中的真实有效性。该项目的目标是比较接受高剂量治疗/自体干细胞移植 (HDT/ASCT) 的多发性骨髓瘤患者与未接受高剂量治疗/自体干细胞移植 (HDT/ASCT) 的患者的老年综合征患病率，并确定哪些患者容易出现功能状态下降。中心假设是，基线时患有合并症或至少有一项 IADL 存在依赖性的患者接受 HDT/ASCT 强化治疗的可能性较小，并且患有合并症的患者在 6 个月的随访后更有可能出现 IADL 残疾。拟议研究的基本原理是，了解基线老年因素对治疗决策的影响并确定哪些患者面临功能下降的风险，将有助于对面临功能下降风险的老年 MM 患者进行更个性化的决策和有针对性的干预。这些目标将通过两个具体目标来实现：1）探讨新诊断多发性骨髓瘤老年人的基线老年评估与初始治疗选择之间的关系； 2) 确定基线老年综合征是否预示新诊断多发性骨髓瘤老年人在 6 个月随访时功能状态下降。目标 1 将通过一项前瞻性试点队列研究来实现，该研究纳入了 30 名 65 岁以上、近期在华盛顿大学 Siteman 癌症中心就诊的 MM 患者。患者将完成癌症与衰老研究小组老年评估工具；将评估基线老年评估和初始治疗策略（HDT/ASCT 与非移植）之间的关联。对于目标 2，参与目标 1 的队列将在随访 3 个月和 6 个月时接受重复老年评估；将确定功能下降的风险因素。这项研究的贡献是重大的，因为它是一系列研究的第一步，预计将在疾病控制和治疗对生存质量的影响方面比较 HDT/ASCT 与非移植治疗策略的有效性。拟议的研究具有创新性，因为它预测了即将发生的范式转变，其中癌症正在成为一种慢性疾病，使用多发性骨髓瘤作为模型恶性肿瘤来研究老年综合征、治疗选择、癌症治疗的长期毒性和生存之间的相互关系。