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: 8342080
• 负责人: Tanya M Wildes
• 金额: $ 7.6万
• 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 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8342080
• 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. PUBLIC HEALTH RELEVANCE: The proposed research is relevant to public health because 10,000 people die of multiple myeloma each year, most of them older adults. While treatment for multiple myeloma can prolong life, the impact of these treatments on functional status and quality of survival is unknown. Thus, the proposed research is relevant to the National Institute of Aging's mission to extend the healthy, active years of life.

描述（由申请人提供）：在未来二十年内，患有多发性骨髓瘤（MM）的老年人数量将翻一番，但在基线老年综合征对老年MM患者治疗选择、毒性和结局的影响方面存在根本性的知识空白。迄今为止，尚无MM研究纳入全面的老年评估或评估治疗对老年领域随时间推移的影响。本项目的长期目标是：1）将老年评估纳入老年MM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下降; 2）通过检查老年MM治疗的真实有效性，促进临床医生和患者的决策。本项目的目的是比较接受高剂量治疗/自体干细胞移植（HDT/ASCT）与未接受高剂量治疗/自体干细胞移植的MM患者中老年综合征的患病率，并确定哪些患者容易出现功能状态下降。中心假设是，基线时存在至少一种IADL的合并症或依赖性的患者不太可能接受HDT/ASCT强化治疗，并且存在合并症的患者在6个月随访后更可能发生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，并确定哪些患者存在功能下降的风险，将允许对存在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实现：1）探索基线老年评估与新诊断多发性骨髓瘤老年患者初始治疗选择之间的关系; 2）确定基线老年综合征是否可预测新诊断多发性骨髓瘤老年患者6个月随访时功能状态的下降。目标1将在Siteman癌症中心/华盛顿大学的30例65岁以上近期诊断为MM的患者的前瞻性试点队列研究中实现。患者将完成癌症和衰老研究组老年评估工具;将评估基线老年评估与初始治疗策略（HDT/ASCT vs非移植）之间的相关性。对于目标2，入组目标1的队列将在3个月和6个月随访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要的，因为它是连续研究的第一步，预计将比较HDT/ASCT与非移植治疗策略在疾病控制和治疗对生存质量的影响方面的有效性。拟议的研究是创新的，因为它预计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MM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。 公共卫生关系：这项研究与公共卫生有关，因为每年有1万人死于多发性骨髓瘤，其中大多数是老年人。虽然多发性骨髓瘤的治疗可以延长生命，但这些治疗对功能状态和生存质量的影响尚不清楚。因此，拟议中的研究与国家老龄化研究所的使命有关，即延长健康、活跃的寿命。