geriatric oncology

老年肿瘤学
  • 文章类型: Journal Article
    目的:老年血液肿瘤幸存者(HCS)的健康相关生活质量(HRQOL)受损程度尚未得到充分研究。因此,我们与社区样本(CS)相比,检查了老年HCS的HRQOL,并调查了社会人口统计学,疾病和治疗特异性,老年病学,和心理社会因素与HRQOL降低相关。
    方法:在这项基于癌症登记的横断面比较研究中,200例HCS,年龄≥70岁,252名年龄和性别匹配的CS人员完成了经过验证的问卷,包括EORTCQLQ-C30和EORTCQLQ-ELD14。
    结果:较老的HCS报告了全球QOL维度中的HRQOL降低,物理,角色,社会功能(临床意义小)和更高的疲劳症状负担,恶心和呕吐,食欲减退,与CS相比,流动性较差(中等强度的疲劳和流动性,其他临床意义较小)。共病的感知疾病负担,功能性残疾,心理困扰,在多元线性回归分析中,抑郁症和抑郁症对老年HCS患者的HRQOL降低有统计学意义(R2=.602,p<.001)。
    结论:功能限制和个体症状的筛查和治疗以及将老年评估纳入肿瘤学实践可以帮助确定支持性护理需求,为了实现个性化,以患者为中心的癌症生存护理计划和改善老年HCS的HRQOL。
    OBJECTIVE: The extent of health-related quality of life (HRQOL) impairments in older hematological cancer survivors (HCS) has not been sufficiently studied. We therefore examined HRQOL in older HCS compared to a community sample (CS) and investigated sociodemographic, disease- and treatment-specific, geriatric, and psychosocial factors associated with reduced HRQOL.
    METHODS: In this cancer-register-based cross-sectional comparative study 200 HCS, aged ≥70 years, and 252 persons of an age- and gender-matched CS completed validated questionnaires including the EORTC QLQ-C30 and EORTC QLQ-ELD14.
    RESULTS: Older HCS reported a reduced HRQOL in the dimensions of global QOL, physical, role, and social functioning (small clinical significance) and higher symptom burden of fatigue, nausea and vomiting, appetite loss, and poorer mobility compared to the CS (fatigue and mobility with medium, the others with small clinical significance). Perceived disease burden of comorbidities, functional disabilities, psychological distress, and depression showed statistical significance for reduced HRQOL in older HCS in multiple linear regression analysis (R2 = .602, p < .001).
    CONCLUSIONS: The screening and treatment of functional limitations and individual symptoms and the integration of a geriatric assessment into oncological practice can help to identify supportive care needs, to implement individualized, patient-centered cancer survivorship care programs and to improve older HCS\'s HRQOL.
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  • 文章类型: Observational Study
    暂无摘要。
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  • 文章类型: Journal Article
    背景:严重疾病对话可以帮助患者避免不必要的治疗。我们先前为患有急性髓细胞性白血病和骨髓增生异常综合征的老年人试行了远程健康严重疾病护理计划(SICP)。
    目的:在本研究中,我们旨在从临床医生的角度了解远程医疗SICP的经验。
    方法:我们研究了10名临床医生,他们向20名患有急性髓细胞性白血病或骨髓增生异常综合征的老年人提供了远程医疗SICP。定量结果包括置信度和可接受性。使用22项调查(范围1-7;得分越高越好)来衡量信心。使用11项调查(5点Likert量表)测量可接受性。由于试点性质和样本量小,在α=.10(2尾)进行了假设检验。临床医生在研究结束时参加了音频记录的定性访谈,以讨论他们的经验。
    结果:共有8名临床医生完成了置信度测量,7名临床医生完成了可接受性测量。我们发现总体置信度有统计学上的显着增加(平均增加0.5,SD0.6;P=0.03)。信心增加最大的是帮助家庭和解和告别(平均1.4,标准差1.5;P=.04)。大多数临床医生同意该格式简单(6/7,86%)且易于使用(6/7,86%)。临床医生认为远程医疗SICP可有效了解患者对临终关怀的价值(7/7,100%)。总共出现了三个定性主题:(1)远程医疗SICP加深了关系并重新建立了信任;(2)每次远程医疗SICP访问都以积极的方式感到独特和个性化;(3)不间断,不匆忙的时间优化了访问体验。
    结论:远程医疗SICP增加了进行严重疾病对话的信心,同时加深了患者与临床医生的关系。
    背景:ClinicalTrials.govNCT04745676;https://www.临床试验.gov/研究/NCT04745676。
    BACKGROUND: Serious illness conversations may help patients avoid unwanted treatments. We previously piloted the telehealth Serious Illness Care Program (SICP) for older adults with acute myeloid leukemia and myelodysplastic syndrome.
    OBJECTIVE: In this study, we aimed to understand the experience of the telehealth SICP from the clinician\'s perspective.
    METHODS: We studied 10 clinicians who delivered the telehealth SICP to 20 older adults with acute myeloid leukemia or myelodysplastic syndrome. Quantitative outcomes included confidence and acceptability. Confidence was measured using a 22-item survey (range 1-7; a higher score is better). Acceptability was measured using an 11-item survey (5-point Likert scale). Hypothesis testing was performed at α=.10 (2-tailed) due to the pilot nature and small sample size. Clinicians participated in audio-recorded qualitative interviews at the end of the study to discuss their experience.
    RESULTS: A total of 8 clinicians completed the confidence measure and 7 clinicians completed the acceptability measure. We found a statistically significant increase in overall confidence (mean increase of 0.5, SD 0.6; P=.03). The largest increase in confidence was in helping families with reconciliation and goodbye (mean 1.4, SD 1.5; P=.04). The majority of clinicians agreed that the format was simple (6/7, 86%) and easy to use (6/7, 86%). Clinicians felt that the telehealth SICP was effective in understanding their patients\' values about end-of-life care (7/7, 100%). A total of three qualitative themes emerged: (1) the telehealth SICP deepened relationships and renewed trust; (2) each telehealth SICP visit felt unique and personal in a positive way; and (3) uninterrupted, unrushed time optimized the visit experience.
    CONCLUSIONS: The telehealth SICP increased confidence in having serious illness conversations while deepening patient-clinician relationships.
    BACKGROUND: ClinicalTrials.gov NCT04745676; https://www.clinicaltrials.gov/study/NCT04745676.
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  • 文章类型: Journal Article
    身体活动对癌症患者很重要。患有癌症的老年人(OACA)对COVID-19感染及其结局的影响不成比例。这项研究调查了COVID-19大流行和相关限制如何影响加拿大一个省的OACA的身体活动。
    进行了在线横断面调查。使用描述性和推断性统计对定量数据进行分析,SPSS®版本27。对自由文本问题的答案进行了分组,基于主题类别。
    115个OACA参与了这项研究;自COVID-19大流行以来,超过46%的人报告称身体活动水平较低。参与者描述了久坐行为的增加和整体体力活动的减少。他们还描述了身体活动的障碍,并对远程提供的身体活动干预保持开放。
    大流行破坏了OACA的身体活动习惯。未来的努力应该包括加快与远程提供干预措施相关的研究,因为老年人越来越接受这种技术。
    UNASSIGNED: Physical activity is important for individuals with cancer. Older adults with cancer (OACA) have been disproportionally vulnerable to both COVID-19 infection and its outcomes. This study investigated how the COVID-19 pandemic and associated restrictions affected physical activity in OACA in one Canadian province.
    UNASSIGNED: An online cross-sectional survey was conducted. Quantitative data were analyzed using descriptive and inferential statistics, with SPSS® Version 27. Answers to free-text questions were grouped, based on thematic categories.
    UNASSIGNED: One hundred and fifteen OACA participated in this study; more than 46% reported lower levels of physical activity since the COVID-19 pandemic. Participants described increases in sedentary behaviour and reduced physical activity overall. They also described barriers to physical activity, and remained open to remotely delivered physical activity interventions.
    UNASSIGNED: The pandemic disrupted physical activity routines among OACA. Future efforts should include an acceleration of research related to remotely delivered interventions given older adults\' growing acceptance of such technologies.
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  • 文章类型: Journal Article
    酪氨酸激酶抑制剂(TKIs)大大改善了慢性粒细胞白血病(CML)的治疗,生存率接近普通人群。然而,对于老年人来说,稳健的数据仍然有限。这项研究的重点是评估合并症,治疗方法,回应,老年慢性粒细胞白血病患者的生存率。我们的研究是针对以色列四个中心和Moffitt癌症中心的123名老年(≥75岁)CML患者进行的。美国。诊断时的中位年龄为79.1岁,44.7%是八十岁老人。合并症非常常见;心血管危险因素(60%),心血管疾病(42%),年龄调整后的Charlson合并症指数(aaCCI)中位数为5。伊马替尼是领先的一线疗法(69%),而第二代TKIs的使用在2010年后有所增加。大多数患者达到了主要的分子反应(MMR,66.7%),一半实现了深层分子反应(DMR,50.4%)。超过一半(52.8%)的病人转到二线,近四分之一(23.5%)接受三线治疗,主要是因为不宽容。aaCCI评分低于5的患者和获得DMR的患者的总生存期(OS)明显更长。与预期相反,以色列队列显示实际预期寿命比预期短,表明CML对老年人生存有较大影响。总之,伊马替尼仍然是主要的初始治疗,但第二代TKIs在老年CML患者中呈上升趋势.老年CML患者的预后取决于合并症,TKI类型,回应,和年龄,强调需要个性化治疗和对TKI有效性和安全性的额外研究。
    Tyrosine kinase inhibitors (TKIs) have greatly improved chronic myeloid leukemia (CML) treatments, with survival rates close to the general population. Yet, for the very elderly, robust data remains limited. This study focused on assessing comorbidities, treatment approaches, responses, and survival for elderly CML patients. Our study was conducted on 123 elderly (≥ 75 years) CML patients across four centers in Israel and Moffitt Cancer Center, USA. The median age at diagnosis was 79.1 years, with 44.7% being octogenarians. Comorbidities were very common; cardiovascular risk factors (60%), cardiovascular diseases (42%), with a median age-adjusted Charlson Comorbidity Index (aaCCI) of 5. Imatinib was the leading first-line therapy (69%), while the use of second-generation TKIs increased post-2010. Most patients achieved a major molecular response (MMR, 66.7%), and half achieved a deep molecular response (DMR, 50.4%). Over half (52.8%) of patients moved to second-line, and nearly a quarter (23.5%) to third-line treatments, primarily due to intolerance. Overall survival (OS) was notably longer in patients with an aaCCI score below 5, and in patients who attained DMR. Contrary to expectations, the Israeli cohort showed a shorter actual life expectancy than projected, suggesting a larger impact of CML on elderly survival. In summary, imatinib remains the main initial treatment, but second-generation TKIs are on the rise among elderly CML patients. Outcomes in elderly CML patients depend on comorbidities, TKI type, response, and age, underscoring the need for personalized therapy and additional research on TKI effectiveness and safety.
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  • 文章类型: Journal Article
    背景:目前,64%的癌症幸存者年龄在65岁以上。老年癌症幸存者在化疗后有独特的并发症,通常被排除在癌症临床试验之外。尽管有关于老年癌症幸存者参与临床试验的障碍的研究,迄今为止,尚无研究探索农村老年癌症幸存者参与临床试验的障碍.
    方法:本研究是一项探索农村老年人生存挑战的研究的二次定性分析。符合条件的参与者是65岁以上的农村居民,他们在过去12个月内完成了治愈性化疗。参与者(n=27)完成了开放式半结构化访谈,其中包括有关参与临床试验障碍的问题。转录本由两名编码员使用主题分析独立编码。我们坚持报告定性研究的标准。
    结果:参与者报告了各种障碍,包括对临床试验的知识有限和恐惧,交通挑战,他们的医生没有通知他们临床试验,认为他们年龄太大,无法参与临床试验。然而,参与者还报告了参与临床试验的促进者,包括承认对自己的健康和社会的好处,了解临床试验的重要性。
    结论:农村老年癌症幸存者面临着许多人际关系,内心,以及参与临床试验的组织障碍。集中于患者的对年龄和位置敏感的干预措施,他们的照顾者,和卫生保健提供者可能会导致农村老年成年幸存者更好地参与临床试验.
    BACKGROUND: Currently, 64% of cancer survivors are aged 65+. Older cancer survivors have unique complications after chemotherapy and are often excluded from cancer clinical trials. Although there is research on barriers to clinical trial participation of older adult cancer survivors, to date no research has explored barriers to clinical trial participation unique to rural older adult cancer survivors.
    METHODS: This study is a secondary qualitative analysis from a study exploring survivorship challenges of rural older adults. Eligible participants were rural residents over age 65 who have completed curative-intent chemotherapy in the past 12 months. Participants (n = 27) completed open-ended semi-structured interviews that included questions on barriers to clinical trial participation. Transcripts were coded independently by two coders using thematic analysis. We have adhered to the standards for reporting qualitative research.
    RESULTS: Participants reported a variety of barriers that included limited knowledge and fear about clinical trials, transportation challenges, their physicians not informing them of clinical trials, and thinking they are too old to participate in clinical trials. However, participants also reported facilitators to participating in clinical trials, including acknowledging benefits to their own health and society, and understanding the importance of clinical trials.
    CONCLUSIONS: Rural older cancer survivors face numerous interpersonal, intrapersonal, and organizational barriers to clinical trial participation. Aging- and location-sensitive interventions that focus on patients, their caregivers, and health care providers may lead to improved participation of rural older adult survivors into clinical trials.
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  • 文章类型: Journal Article
    背景:本研究的目的是评估术前同步放化疗(preCRT)治疗经老年综合评估(CGA)分类为“适合”的老年人局部晚期直肠癌的安全性和有效性。
    方法:单臂,多中心,设计了II期试验。如果患者年龄在70岁或以上,并且符合CGA评估的“适合”(SIOG1)标准和局部晚期风险类别,则符合本研究的条件。主要终点是2年无病生存期(DFS)。患者计划接受预CRT(50Gy)与雷替曲塞(第1天和第22天3mg/m2)。
    结果:通过CGA评估了109例患者,其中八十六人,11和12被归类为适合的,中级和脆弱类别。纳入68名年龄中位数为74岁的患者。64例(94.1%)患者完成放疗,未减少剂量。54例(79.3%)患者按计划完成了规定的雷替曲塞治疗。在24名患者中观察到严重毒性(3级或以上)(35.3%),14例患者(20.6%)出现非血液学副作用。在36.0个月的中位随访时间内(范围:5.9-63.1个月),2年总生存期(OS),癌症特异性生存率(CSS)和无病生存率(DFS)为89.6%(95%CI:82.3-96.9),92.4%(95%CI:85.9-98.9)和75.6%(95%CI:65.2-86.0),分别。48例患者(70.6%)接受了手术(R0切除95.8%,R1切除4.2%),在直肠系膜筋膜状态阳性的患者中,相应的R0切除率为76.6%(36/47).
    结论:这项II期试验表明,在基于CGA评估为适合的老年直肠癌患者中,预CRT具有可耐受的毒性。
    背景:ClinicalTrials.gov上的注册号为NCT02992886(2016年14月12日)。
    BACKGROUND: The purpose of this study was to evaluate the safety and efficacy of preoperative concurrent chemoradiotherapy (preCRT) for locally advanced rectal cancer in older people who were classified as \"fit\" by comprehensive geriatric assessment (CGA).
    METHODS: A single-arm, multicenter, phase II trial was designed. Patients were eligible for this study if they were aged 70 years or above and met the standards of \"fit\" (SIOG1) as evaluated by CGA and of the locally advanced risk category. The primary endpoint was 2-year disease-free survival (DFS). Patients were scheduled to receive preCRT (50 Gy) with raltitrexed (3 mg/m2 on days 1 and 22).
    RESULTS: One hundred and nine patients were evaluated by CGA, of whom eighty-six, eleven and twelve were classified into the fit, intermediate and frail category. Sixty-eight fit patients with a median age of 74 years were enrolled. Sixty-four patients (94.1%) finished radiotherapy without dose reduction. Fifty-four (79.3%) patients finished the prescribed raltitrexed therapy as planned. Serious toxicity (grade 3 or above) was observed in twenty-four patients (35.3%), and fourteen patients (20.6%) experienced non-hematological side effects. Within a median follow-up time of 36.0 months (range: 5.9-63.1 months), the 2-year overall survival (OS), cancer-specific survival (CSS) and disease-free survival (DFS) rates were 89.6% (95% CI: 82.3-96.9), 92.4% (95% CI: 85.9-98.9) and 75.6% (95% CI: 65.2-86.0), respectively. Forty-eight patients (70.6%) underwent surgery (R0 resection 95.8%, R1 resection 4.2%), the corresponding R0 resection rate among the patients with positive mesorectal fascia status was 76.6% (36/47).
    CONCLUSIONS: This phase II trial suggests that preCRT is efficient with tolerable toxicities in older rectal cancer patients who were evaluated as fit based on CGA.
    BACKGROUND: The registration number on ClinicalTrials.gov was NCT02992886 (14/12/2016).
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  • 文章类型: Journal Article
    背景:我们试图确定在年龄≥70岁的T1N0HR+乳腺癌患者中,针对老年人的特定考虑因素如何影响腋窝手术使用的外科医生内变异。
    方法:确定2013年至2015年在SEER-Medicare中诊断为T1N0HR+/HER2阴性乳腺癌的女性≥70岁,并与美国医学协会Masterfile相关联。感兴趣的结果是腋窝手术。关键患者水平变量包括Charlson合并症指数(CCI)评分,脆弱(基于基于索赔的脆弱指数得分),和年龄(≥75vs<75)。使用具有外科医生集群的多级混合模型来估计内相关系数(ICC)(外科医生之间的方差),1-ICC代表外科医生内部差异。
    结果:在4410名参与者中,6.1%的CCI评分≥3,20.7%的患者虚弱,58.3%≥75岁;86.1%接受了腋窝手术。没有外科医生在所有患者中省略腋窝手术,但42.3%的外科医生在所有患者中进行了腋窝手术。在空模型中,腋窝评估中10.5%的差异归因于外科医生之间的差异。调整CCI分数后,脆弱,混合模型中的年龄,外科医生之间的差异增加到13.0%。
    结论:在这个人群中,外科医生之间的腋窝手术差异更大,这表明外科医生没有采取“要么全有要么全无”的方法。合并症,脆弱,年龄在变异中所占的比例很小,建议细微差别的决策可能包括额外的,无法测量的因素,如外科医生与患者沟通的差异。
    BACKGROUND: We sought to determine how considerations specific to older adults impact between- and within-surgeon variation in axillary surgery use in women ≥70 years with T1N0 HR+ breast cancer.
    METHODS: Females ≥70 years with T1N0 HR+/HER2-negative breast cancer diagnosed from 2013 to 2015 in SEER-Medicare were identified and linked to the American Medical Association Masterfile. The outcome of interest was axillary surgery. Key patient-level variables included the Charlson Comorbidity Index (CCI) score, frailty (based on a claims-based frailty index score), and age (≥75 vs <75). Multilevel mixed models with surgeon clusters were used to estimate the intracluster correlation coefficient (ICC) (between-surgeon variance), with 1-ICC representing within-surgeon variance.
    RESULTS: Of the 4410 participants included, 6.1% had a CCI score of ≥3, 20.7% were frail, and 58.3% were ≥ 75 years; 86.1% underwent axillary surgery. No surgeon omitted axillary surgery in all patients, but 42.3% of surgeons performed axillary surgery in all patients. In the null model, 10.5% of the variance in the axillary evaluation was attributable to between-surgeon differences. After adjusting for CCI score, frailty, and age in mixed models, between-surgeon variance increased to 13.0%.
    CONCLUSIONS: In this population, axillary surgery varies more within surgeons than between surgeons, suggesting that surgeons are not taking an \"all-or-nothing\" approach. Comorbidities, frailty, and age accounted for a small proportion of the variation, suggesting nuanced decision-making may include additional, unmeasured factors such as differences in surgeon-patient communication.
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  • 文章类型: Journal Article
    背景:高强度临终(EoL)护理对患者来说可能是繁重的,看护者,和卫生系统,并不赋予任何有意义的临床益处。然而,关于高强度EoL护理的预测因素存在显著的知识差距.在这项研究中,我们在患有四种最常见恶性肿瘤的老年人中确定了与高强度EoL护理相关的危险因素,包括乳房,前列腺,肺,还有结直肠癌.
    方法:使用SEER-Medicare数据,我们对65岁及以上死于乳腺癌的医疗保险受益人进行了回顾性分析,前列腺,肺,或结直肠癌在2011年至2015年之间。我们使用多变量逻辑回归来确定临床,人口统计学,社会经济,以及高强度EoL护理的地理预测因子,我们定义为在急性护理医院死亡,在死亡后14天内接受任何口服或肠胃外化疗,在死亡后30天内有一次或多次入住重症监护室,死亡后30天内两次或两次以上的急诊科就诊,或在死亡后30天内两次或两次以上住院。
    结果:在59,355名死者中,与接受高强度EOL护理的可能性增加相关的因素是合并症负担增加(比值比[OR]:1.29;95%置信区间[CI]:1.28-1.30),女性(OR:1.05;95%CI:1.01-1.09),黑人种族(OR:1.14;95%CI:1.07-1.23),其他种族/民族(OR:1.20;95%CI:1.10-1.30),III期疾病(OR:1.11;95%CI:1.05-1.18),生活在人口>1,000,000的县(OR:1.23;95%CI:1.16-1.31),生活在10%-<20%贫困(OR:1.09;95%CI:1.03-1.16)或20%-100%贫困(OR:1.12;95%CI:1.04-1.19)的人口普查区域,并拥有国家补贴的医疗保险保费(OR:1.18;95%CI:1.12-1.24)。在年龄较大的患者中,高强度EoL护理的风险较低(OR:0.98;95%CI:0.98-0.99),居住在中西部(OR:0.69;95%CI:0.65-0.75),南部(OR:0.70;95%CI:0.65-0.74),或西部(OR:0.81;95%CI:0.77-0.86),大部分生活在农村地区(OR:0.92;95%CI:0.86-1.00),并且表现不佳(OR:0.26;95%CI:0.25-0.28)。不同癌症类型的结果基本一致。
    结论:我们研究中确定的危险因素可以为可能接受高强度EoL治疗的癌症患者提供新干预措施的开发。卫生系统应考虑将这些风险因素纳入决策支持工具,以帮助临床医生确定哪些患者应接受临终关怀和姑息治疗。
    BACKGROUND: High-intensity end-of-life (EoL) care can be burdensome for patients, caregivers, and health systems and does not confer any meaningful clinical benefit. Yet, there are significant knowledge gaps regarding the predictors of high-intensity EoL care. In this study, we identify risk factors associated with high-intensity EoL care among older adults with the four most common malignancies, including breast, prostate, lung, and colorectal cancer.
    METHODS: Using SEER-Medicare data, we conducted a retrospective analysis of Medicare beneficiaries aged 65 and older who died of breast, prostate, lung, or colorectal cancer between 2011 and 2015. We used multivariable logistic regression to identify clinical, demographic, socioeconomic, and geographic predictors of high-intensity EoL care, which we defined as death in an acute care hospital, receipt of any oral or parenteral chemotherapy within 14 days of death, one or more admissions to the intensive care unit within 30 days of death, two or more emergency department visits within 30 days of death, or two or more inpatient admissions within 30 days of death.
    RESULTS: Among 59,355 decedents, factors associated with increased likelihood of receiving high-intensity EoL care were increased comorbidity burden (odds ratio [OR]:1.29; 95% confidence interval [CI]:1.28-1.30), female sex (OR:1.05; 95% CI:1.01-1.09), Black race (OR:1.14; 95% CI:1.07-1.23), Other race/ethnicity (OR:1.20; 95% CI:1.10-1.30), stage III disease (OR:1.11; 95% CI:1.05-1.18), living in a county with >1,000,000 people (OR:1.23; 95% CI:1.16-1.31), living in a census tract with 10%-<20% poverty (OR:1.09; 95% CI:1.03-1.16) or 20%-100% poverty (OR:1.12; 95% CI:1.04-1.19), and having state-subsidized Medicare premiums (OR:1.18; 95% CI:1.12-1.24). The risk of high-intensity EoL care was lower among patients who were older (OR:0.98; 95% CI:0.98-0.99), lived in the Midwest (OR:0.69; 95% CI:0.65-0.75), South (OR:0.70; 95% CI:0.65-0.74), or West (OR:0.81; 95% CI:0.77-0.86), lived in mostly rural areas (OR:0.92; 95% CI:0.86-1.00), and had poor performance status (OR:0.26; 95% CI:0.25-0.28). Results were largely consistent across cancer types.
    CONCLUSIONS: The risk factors identified in our study can inform the development of new interventions for patients with cancer who are likely to receive high-intensity EoL care. Health systems should consider incorporating these risk factors into decision-support tools to assist clinicians in identifying which patients should be referred to hospice and palliative care.
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  • 文章类型: Clinical Trial Protocol
    背景:老年癌症患者从健康到虚弱,有各种合并症和对化疗的韧性。除了恶心和疲劳,大量患者在化疗后出现头晕和行走平衡受损,这对他们的功能能力和健康相关的生活质量有很大影响。症状很容易被忽视,因此经常被低估和管理,这就是为什么症状最终会成为持久的副作用。这项研究的目的是调查头晕的发展,行走平衡下降,和肌肉减少症以及全面的老年评估和12周的分组运动对这些症状的影响。运动干预包括前庭和平衡练习,和渐进式阻力训练,以抵消接受化疗的老年结直肠癌患者的症状。
    方法:这是一项随机对照试验,包括≥65岁开始(neo)辅助或一线姑息性化疗治疗结直肠癌的患者。患者将接受全面的评估计划,包括前庭功能的测量,balance,肌肉力量,质量,和耐力,外周和自主神经功能,和头晕的主观测量,担心坠落,和健康相关的生活质量。测试将在基线处进行,12、24周。患者将根据化疗方案和随机1:1进行全面的老年病评估和锻炼三次/周或对照进行三个不同的随机对照试验。两组参与者将继续接受常规护理,包括标准化的肿瘤治疗。总的来说,需要150名患者来评估以下两个主要结果:(1)用动态步态指数评估的步行平衡的维持,以及(2)在12周时用30秒的坐姿测试评估的下肢力量和耐力。主要结果将使用调查组间差异的混合线性回归模型进行分析。
    结论:试验注册于2023年4月开始,是第一个评估头晕原因的试验,行走平衡下降,接受化疗的老年患者的肌肉减少症。该试验将提供新的和有价值的知识,如何评估,管理,防止头晕,行走平衡下降,老年结直肠癌患者的肌肉减少症。
    背景:区域道德委员会(j。nr.H-22064206)。丹麦数据保护署(P-2023-86)和ClinicalTrials.gov(NCT05710809)。
    BACKGROUND: Older patients with cancer range from fit to frail with various comorbidities and resilience to chemotherapy. Besides nausea and fatigue, a significant number of patients experience dizziness and impaired walking balance after chemotherapy, which can have great impact on their functional ability and health related quality of life. Symptoms are easily overlooked and therefore often underreported and managed, which is why symptoms could end up as long-lasting side effects. The aim of this study is to investigate the development of dizziness, decline in walking balance, and sarcopenia and the effect of a comprehensive geriatric assessment and 12 weeks of group-based exercise on these symptoms. The exercise intervention includes vestibular and balance exercises, and progressive resistance training, to counteract the symptoms in older patients with colorectal cancer treated with chemotherapy.
    METHODS: This is a randomized controlled trial including patients ≥65 years initiating (neo)adjuvant or first-line palliative chemotherapy for colorectal cancer. Patients will undergo a comprehensive assessment program including measures of vestibular function, balance, muscle strength, mass, and endurance, peripheral and autonomic nerve function, and subjective measures of dizziness, concern of falling, and health related quality of life. Tests will be performed at baseline, 12, and 24 weeks. Patients will be placed in three different randomized controlled trials depending on chemotherapy regimen and randomized 1:1 to comprehensive geriatric assessment and exercise three times/week or control. Participants in both groups will continue with usual care, including standardized oncological treatment. In total, 150 patients are needed to assess the two primary outcomes of (1) maintenance of walking balance assessed with Dynamic Gait Index and (2) lower limb strength and endurance assessed with 30 Second Sit-to-Stand Test at 12 weeks. The primary outcomes will be analyzed using a mixed linear regression model investigating the between-group differences.
    CONCLUSIONS: Trial enrollment began in April 2023 and is the first trial to evaluate reasons for dizziness, decline in walking balance, and sarcopenia in older patients receiving chemotherapy. The trial will provide new and valuable knowledge in how to assess, manage, and prevent dizziness, decline in walking balance, and sarcopenia in older patients with colorectal cancer.
    BACKGROUND: The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).
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