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Health-related quality of life and supportive care needs in young adult cancer survivors-a longitudinal population-based study. 年轻成年癌症幸存者的健康相关生活质量和支持性护理需求--一项基于人群的纵向研究。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-22 DOI: 10.1007/s00520-024-08896-3
Alexandra Wide, Johan Ahlgren, Karin E Smedby, Kristina Hellman, Roger Henriksson, Olof Ståhl, Claudia Lampic, Lena Wettergren

Purpose: To examine health-related quality of life (HRQoL) and supportive care needs among young adult (YA) cancer survivors up to 3 years post-diagnosis.

Methods: A national cohort of individuals diagnosed at 18-39 years with breast, cervical, ovarian, or testicular cancer, lymphoma or brain tumor was approached with surveys at 1.5 (n = 1010, response rate 67%) and 3 (n = 722) years post-diagnosis. HRQoL was measured using the EORTC QLQ-C30. Scores were dichotomized using cut-off scores to predict supportive care needs in the Supportive Care Needs Survey-Long Form 59 (SCNS-LF59). Swedish cancer quality registers provided clinical data. Factors predicting need of support at 1.5 and 3 years post-diagnosis were identified using logistic regression.

Results: HRQoL improvements over time were trivial to small. At both time points, a majority of respondents rated HRQoL levels indicating supportive care needs. At 1.5 years post-diagnosis, the risk of having support needs was lower among survivors with testicular cancer (compared to lymphoma) or university-level education, and higher among those on treatment (predominantly endocrine therapy). At 3 years post-diagnosis, when controlling for previous HRQoL scores, most correlations persisted, and poor self-rated household economy and chronic health conditions were additionally associated with supportive care needs.

Conclusion: A majority of YAs diagnosed with cancer rate HRQoL at levels indicating support needs up to 3 years post-diagnosis. Testicular cancer survivors are at lower risk of having support needs. Concurrent health conditions and poor finances are linked to lower HRQoL. More efforts are needed to provide adequate, age-appropriate support to YA cancer survivors.

目的:研究青壮年癌症幸存者在确诊后三年内与健康相关的生活质量(HRQoL)和支持性护理需求:对全国 18-39 岁确诊为乳腺癌、宫颈癌、卵巢癌或睾丸癌、淋巴瘤或脑瘤的人群进行了调查,调查时间为确诊后 1.5 年(n = 1010,回复率为 67%)和 3 年(n = 722)。HRQoL 采用 EORTC QLQ-C30 进行测量。评分采用临界值进行二分法,以预测支持性护理需求调查长表 59(SCNS-LF59)中的支持性护理需求。瑞典癌症质量登记册提供了临床数据。采用逻辑回归法确定了诊断后 1.5 年和 3 年的支持性护理需求预测因素:结果:随着时间的推移,HRQoL 的改善幅度很小。在这两个时间点,大多数受访者的 HRQoL 水平都表明需要支持性护理。在确诊后 1.5 年,睾丸癌(与淋巴瘤相比)幸存者或受过大学教育的幸存者有支持性护理需求的风险较低,而正在接受治疗(主要是内分泌治疗)的幸存者有支持性护理需求的风险较高。在确诊后3年,如果控制以前的HRQoL评分,大多数相关性仍然存在,自评家庭经济状况不佳和慢性健康状况也与支持性护理需求相关:结论:大多数确诊癌症的青年在确诊后三年内的 HRQoL 评分水平表明他们需要支持性护理。睾丸癌幸存者需要支持的风险较低。并发症和经济状况不佳与较低的 HRQoL 有关。需要做出更多努力,为亚健康癌症幸存者提供充分的、适合其年龄的支持。
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引用次数: 0
Feasibility, acceptability, and preliminary efficacy of a self-directed online psychosocial intervention for women with metastatic breast cancer: Finding My Way-Advanced. 针对转移性乳腺癌女性患者的自主在线心理干预的可行性、可接受性和初步疗效:寻找我的路--高级版
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-22 DOI: 10.1007/s00520-024-08924-2
Amy Rigg, Emma Kemp, Bogda Koczwara, Phyllis Butow, Afaf Girgis, Nicholas J Hulbert-Williams, Billingsley Kaambwa, Riki Long, Penelope Schofield, Jane Turner, Desmond Yip, Robyn Combes, Lisa Beatty

Purpose: Few digital interventions target patients with advanced cancer. Hence, we feasibility-tested Finding My Way-Advanced (FMW-A), a self-guided program for women with metastatic breast cancer.

Methods: A single-site randomised controlled pilot trial was conducted. Participants were recruited through clinicians, professional networks, and social media and randomised to intervention or usual-care control. Participants were randomly allocated to either the intervention (FMW-A; a 6-week, 6-module CBT-based online self-directed psychosocial program for women with MBC + usual care resources) or control (usual care resources: BCNA's Hope and Hurdles kit). Feasibility outcomes included rates of recruitment, uptake, engagement, and attrition. Distress, QOL, and unmet needs were evaluated for signals of efficacy, and qualitative feedback was collected to assess acceptability.

Results: Due to COVID-19 and funding constraints, the target recruitment of 40 was not reached (n = 60 approached; n = 55 eligible; n = 35 consented). Uptake was high (n = 35/55; 63.6%), engagement modest (median 3/6 modules per user), and attrition acceptable (66% completed post-treatment). Efficacy signals were mixed: compared to controls, FMW-A participants experienced small improvements in fear of progression (d = 0.21) and global QOL (d = 0.22) and demonstrated a trend towards improvements in cancer-specific distress (d = 0.13) and role functioning (d = 0.18). However, FMW-A participants experienced small-to-moderate deteriorations in general distress (d = 0.23), mental QOL (d = 0.51), and social functioning (d = 0.27), whereas controls improved. Qualitatively, participants (n = 4) were satisfied with the program, perceived it as appropriate, but noted some sections could evoke transient distress.

Conclusion: The study demonstrated feasibility (high uptake and acceptable retention) and generated realistic recruitment estimates. While FMW-A appears promising for targeting cancer-specific distress and fear of progression, the mixed findings in quality of life and general distress warrant further revisions and testing.

目的很少有针对晚期癌症患者的数字干预措施。因此,我们对Finding My Way-Advanced (FMW-A)进行了可行性测试:方法:我们进行了一项单点随机对照试点试验。参与者通过临床医生、专业网络和社交媒体招募,并随机分配到干预或常规护理对照组。参与者被随机分配到干预项目(FMW-A;为期 6 周、6 个模块、基于 CBT 的在线自我指导心理社会项目,适用于 MBC 女性患者 + 常规护理资源)或对照项目(常规护理资源:BCNA 的 "希望与障碍 "工具包)。可行性结果包括招募率、接受率、参与率和流失率。对苦恼、QOL和未满足的需求进行评估,以发现疗效信号,并收集定性反馈以评估可接受性:由于 COVID-19 和资金的限制,未达到招募 40 人的目标(接触人数 = 60 人;符合条件人数 = 55 人;同意人数 = 35 人)。接受率较高(n = 35/55; 63.6%),参与度适中(中位数为每个用户 3/6 个模块),自然减员率可接受(66% 完成治疗后)。疗效信号好坏参半:与对照组相比,FMW-A 参与者对病情恶化的恐惧(d = 0.21)和整体 QOL(d = 0.22)略有改善,癌症特异性困扰(d = 0.13)和角色功能(d = 0.18)也有改善趋势。然而,FMW-A 参与者在一般痛苦(d = 0.23)、心理 QOL(d = 0.51)和社会功能(d = 0.27)方面出现了小到中等程度的恶化,而对照组则有所改善。从质量上看,参与者(n = 4)对该计划表示满意,认为该计划是适当的,但指出某些部分可能会引起短暂的痛苦:该研究证明了其可行性(高接受率和可接受的保留率),并得出了切合实际的招募估算。虽然 FMW-A 在针对癌症特异性困扰和对病情恶化的恐惧方面似乎很有前景,但在生活质量和一般困扰方面的研究结果喜忧参半,需要进一步修订和测试。
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引用次数: 0
Enhancing patient-centered care: a randomized study on G-CSF administration preferences in chemotherapy-induced neutropenia. 加强以患者为中心的护理:化疗所致中性粒细胞减少症患者 G-CSF 给药偏好的随机研究。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-22 DOI: 10.1007/s00520-024-08929-x
Nathaniel Scher, Hanène Boudabous, Judith Partouche, Saeedeh Rezaee-Vessal, Paul Ihout, Claudia Rizzo, Hanah Lamallem, Olivier Bauduceau, Ilan Darmon, Marc Bollet, Clément Draghi, Alain Toledano

Purpose: Chemotherapy-induced neutropenia poses a significant risk to cancer patients, with pegfilgrastim being commonly used for its prevention. While pegfilgrastim can be administered via prefilled syringe or pen device, patient preferences and experiences with these delivery methods remain unclear.

Methods: We conducted a prospective, open-label, randomized, observational trial (NCT05910164) at the Rafael Institute, France, comparing patient preferences for pegfilgrastim administration using a prefilled syringe versus a prefilled pen device. Patients undergoing chemotherapy and requiring pegfilgrastim were enrolled and randomized 1:1 to receive either syringe or pen first, with crossover administration. Questionnaires assessed patient preferences, learning experiences, autonomy, pain levels, emotional responses, satisfaction with nursing care, and empowerment.

Results: Among 150 randomized patients (mean age 58 years; 69% female), both groups showed a preference for the pen device, with significantly higher mean scores favoring pen administration (4.94 ± 1.70 vs. 4.27 ± 1.84; p = 0.00106). Patients reported significantly lower perceived pain with pen administration and stronger positive emotions compared to syringe use. Satisfaction with nursing care was higher with syringe use. Empowerment levels were similar across groups but significantly stronger when using the pen in complete autonomy.

Conclusion: A preference for pegfilgrastim administration via the pen device was observed, though this may have been influenced by the administration sequence and the absence of syringe self-administration. The insights gained can help inform clinical decision-making and improve patient-centered care in managing chemotherapy-induced neutropenia.

Trial registration: NCT05910164 on June 15, 2023.

目的:化疗引起的中性粒细胞减少症对癌症患者构成重大风险,而 pegfilgrastim 常用于预防中性粒细胞减少症。虽然 pegfilgrastim 可通过预充式注射器或笔式装置给药,但患者对这些给药方法的偏好和体验仍不清楚:我们在法国拉斐尔研究所进行了一项前瞻性、开放标签、随机观察试验(NCT05910164),比较了患者对使用预充式注射器和预充式笔装置给药 pegfilgrastim 的偏好。接受化疗并需要使用 pegfilgrastim 的患者被纳入其中,并按 1:1 的比例随机分配,先使用注射器或笔,然后交叉给药。问卷调查评估了患者的偏好、学习经历、自主性、疼痛程度、情绪反应、对护理的满意度以及能力:在随机抽取的 150 名患者(平均年龄 58 岁;69% 为女性)中,两组患者均表示更倾向于使用笔式装置,笔式给药的平均得分明显更高(4.94 ± 1.70 vs. 4.27 ± 1.84;p = 0.00106)。与使用注射器相比,患者对笔式给药的疼痛感明显降低,积极情绪也更强烈。使用注射器时,患者对护理服务的满意度更高。各组的授权水平相似,但在完全自主的情况下使用笔时,授权水平明显更高:尽管这可能受到给药顺序和不使用注射器自主给药的影响,但观察到患者更倾向于通过笔式装置给药。所获得的见解有助于为临床决策提供依据,并在管理化疗引起的中性粒细胞减少症时改善以患者为中心的护理:试验注册:NCT05910164,2023年6月15日。
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引用次数: 0
Surgical and non-surgical predictors of long term erectile function after robot assisted radical prostatectomy. 机器人辅助根治性前列腺切除术后长期勃起功能的手术和非手术预测因素。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-21 DOI: 10.1007/s00520-024-08936-y
Tillier Cn, Cox Il, Hagens Mj, Nicolai Mpj, van Muilekom Ham, van Leeuwen Pj, van de Poll-Franse Lv, van der Poel Hg

Purpose: Robotic-assisted radical prostatectomy (RARP) impairs erectile function (EF) due to the surgical procedure and non-surgical factors. Non-surgical factors may contribute to recovery of erectile function (EFR) after RARP. This study assessed the role of non-surgical factors including physical activity in baseline EF and EFR after prostatectomy.

Methods: Patient Reported Measure Outcomes questionnaires from patients with localized prostate carcinoma who underwent a RARP with a postoperative follow up (FU) of 3 years. EFR was defined as at least 70% EF recovery of baseline IIEF-EF. Physical activities was defined as no activity at all, once a week and ≥ 2 a week.

Results: In total 804 patients were included. At baseline, age, lower urinary tract symptoms (LUTS), having a partner and former smoking were significantly associated (p < .001) of EF. Postoperatively, the extent of nerve sparing and baseline EF were strongly associated with EFR (p < .001). Physical activity ≥ 2 a week predicted EF but only beyond 6 months of FU (p = .005, p = .028 and p = .007 at 1, 2 and 3 year FU respectively). Comorbidities, BMI and the use of medications known to affect EF were not predictive of EFR.

Conclusions: Age, LUTS, having a partner and former smoking were baseline associated with EF prior to RARP. Baseline EF and extent of nerve sparing jointly predicted EFR. Intensive physical activity was an independent predictor of EFR beyond the first year after RARP. Our findings suggests that besides clinical factors, lifestyle may also play a role in recovery of erectile function.

目的:机器人辅助前列腺癌根治术(RARP)会损害勃起功能(EF),这是手术过程和非手术因素造成的。非手术因素可能有助于 RARP 术后勃起功能(EFR)的恢复。本研究评估了包括体育锻炼在内的非手术因素在前列腺切除术后基线勃起功能和勃起功能恢复中的作用:方法:对接受前列腺切除术(RARP)的局部前列腺癌患者进行患者报告测量结果问卷调查,术后随访(FU)3年。EFR的定义是EF至少恢复基线IIEF-EF的70%。体力活动定义为完全不活动、每周一次和每周≥2次:结果:共纳入 804 名患者。在基线时,年龄、下尿路症状(LUTS)、有伴侣和曾经吸烟有显著相关性(p 结论:年龄、下尿路症状(LUTS)、有伴侣和曾经吸烟有显著相关性:年龄、下尿路症状(LUTS)、有伴侣和曾吸烟与 RARP 前的 EF 基线相关。基线 EF 和神经疏通程度共同预测了 EFR。强化体育锻炼是 RARP 术后第一年后 EFR 的独立预测因素。我们的研究结果表明,除了临床因素外,生活方式也可能对勃起功能的恢复起到一定作用。
{"title":"Surgical and non-surgical predictors of long term erectile function after robot assisted radical prostatectomy.","authors":"Tillier Cn, Cox Il, Hagens Mj, Nicolai Mpj, van Muilekom Ham, van Leeuwen Pj, van de Poll-Franse Lv, van der Poel Hg","doi":"10.1007/s00520-024-08936-y","DOIUrl":"10.1007/s00520-024-08936-y","url":null,"abstract":"<p><strong>Purpose: </strong>Robotic-assisted radical prostatectomy (RARP) impairs erectile function (EF) due to the surgical procedure and non-surgical factors. Non-surgical factors may contribute to recovery of erectile function (EFR) after RARP. This study assessed the role of non-surgical factors including physical activity in baseline EF and EFR after prostatectomy.</p><p><strong>Methods: </strong>Patient Reported Measure Outcomes questionnaires from patients with localized prostate carcinoma who underwent a RARP with a postoperative follow up (FU) of 3 years. EFR was defined as at least 70% EF recovery of baseline IIEF-EF. Physical activities was defined as no activity at all, once a week and ≥ 2 a week.</p><p><strong>Results: </strong>In total 804 patients were included. At baseline, age, lower urinary tract symptoms (LUTS), having a partner and former smoking were significantly associated (p < .001) of EF. Postoperatively, the extent of nerve sparing and baseline EF were strongly associated with EFR (p < .001). Physical activity ≥ 2 a week predicted EF but only beyond 6 months of FU (p = .005, p = .028 and p = .007 at 1, 2 and 3 year FU respectively). Comorbidities, BMI and the use of medications known to affect EF were not predictive of EFR.</p><p><strong>Conclusions: </strong>Age, LUTS, having a partner and former smoking were baseline associated with EF prior to RARP. Baseline EF and extent of nerve sparing jointly predicted EFR. Intensive physical activity was an independent predictor of EFR beyond the first year after RARP. Our findings suggests that besides clinical factors, lifestyle may also play a role in recovery of erectile function.</p>","PeriodicalId":22046,"journal":{"name":"Supportive Care in Cancer","volume":"32 11","pages":"738"},"PeriodicalIF":2.8,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Constructing a picture of fatigue in the context of cancer: assessment of construct overlap in common fatigue scales. 构建癌症背景下的疲劳图景:评估常见疲劳量表的结构重叠。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-21 DOI: 10.1007/s00520-024-08930-4
Alexandria Muench, Elizabeth W Lampe, Sheila N Garland, Sammy Dhaliwal, Michael L Perlis

Purpose: Individuals diagnosed with cancer experience multiple inter-related short- and long-term side effects. Chief among such symptomology is cancer-related fatigue (CRF), which, if left unmanaged, can become chronic and result in increased disability and healthcare utilization. A growing number of self-report scales have been developed to measure CRF symptoms based on various theoretical conceptualizations with the aim of promoting targeted assessment and intervention efforts. It may be, however, unwise to assume that the various measures are conceptually similar (i.e., that they assess for the same constructs). Accordingly, we aimed to characterize item content among nine self-report scales, using a Jaccard index to quantify content overlap among scales.

Methods: We characterized construct assessment among nine self-report scales recommended to assess CRF by a recent clinical practice guideline, and used a Jaccard index to quantify content overlap among scales.

Results: Analysis of 208 items across nine rating scales resulted in 20 distinct symptoms of CRF assessed. The most common symptoms were energy level (captured in all nine scales), cognitive function, impaired task performance (in eight scales), sleepiness, and physical function (in seven scales). Mean overlap among all scales was low (Jaccard index = 0.455). Only one construct (duration of fatigue; 5.0%) was captured by a single scale, and one symptom (energy level; 5.0%) was common across all scales. The PFS, MFSI, and BFI each captured at least one symptom from each of the NCCN domains of CRF.

Conclusion: CRF scales are heterogeneous in the content they measure, critically impairing integration of knowledge across studies using disparate scales. Future work is urgently needed to build more integrated theoretical and/or computational models of CRF based on relevant mechanisms.

目的:被诊断为癌症的患者会经历多种相互关联的短期和长期副作用。这些症状中最主要的是癌症相关疲劳(CRF),如果不加以控制,可能会转变为慢性症状,导致残疾和医疗费用的增加。目前已开发出越来越多的自我报告量表,用于测量基于各种理论概念的 CRF 症状,目的是促进有针对性的评估和干预工作。然而,假设各种量表在概念上是相似的(即它们评估的是相同的构造)可能是不明智的。因此,我们旨在描述九个自我报告量表的项目内容特征,并使用 Jaccard 指数来量化量表之间的内容重叠:我们对近期临床实践指南推荐用于评估 CRF 的九个自我报告量表的构建评估进行了特征描述,并使用 Jaccard 指数对各量表之间的内容重叠进行了量化:结果:通过对九个评分量表的 208 个项目进行分析,共评估出 20 种不同的 CRF 症状。最常见的症状是能量水平(所有九个量表均包含)、认知功能、任务执行能力受损(八个量表)、嗜睡和身体功能(七个量表)。所有量表的平均重叠率较低(Jaccard 指数 = 0.455)。只有一个量表反映了一种症状(疲劳持续时间;5.0%),而所有量表都反映了一种症状(能量水平;5.0%)。PFS、MFSI和BFI每个量表至少捕捉到了NCCN CRF各领域中的一种症状:结论:CRF量表测量的内容各不相同,严重影响了使用不同量表的研究之间的知识整合。未来迫切需要开展工作,根据相关机制建立更加综合的 CRF 理论和/或计算模型。
{"title":"Constructing a picture of fatigue in the context of cancer: assessment of construct overlap in common fatigue scales.","authors":"Alexandria Muench, Elizabeth W Lampe, Sheila N Garland, Sammy Dhaliwal, Michael L Perlis","doi":"10.1007/s00520-024-08930-4","DOIUrl":"10.1007/s00520-024-08930-4","url":null,"abstract":"<p><strong>Purpose: </strong>Individuals diagnosed with cancer experience multiple inter-related short- and long-term side effects. Chief among such symptomology is cancer-related fatigue (CRF), which, if left unmanaged, can become chronic and result in increased disability and healthcare utilization. A growing number of self-report scales have been developed to measure CRF symptoms based on various theoretical conceptualizations with the aim of promoting targeted assessment and intervention efforts. It may be, however, unwise to assume that the various measures are conceptually similar (i.e., that they assess for the same constructs). Accordingly, we aimed to characterize item content among nine self-report scales, using a Jaccard index to quantify content overlap among scales.</p><p><strong>Methods: </strong>We characterized construct assessment among nine self-report scales recommended to assess CRF by a recent clinical practice guideline, and used a Jaccard index to quantify content overlap among scales.</p><p><strong>Results: </strong>Analysis of 208 items across nine rating scales resulted in 20 distinct symptoms of CRF assessed. The most common symptoms were energy level (captured in all nine scales), cognitive function, impaired task performance (in eight scales), sleepiness, and physical function (in seven scales). Mean overlap among all scales was low (Jaccard index = 0.455). Only one construct (duration of fatigue; 5.0%) was captured by a single scale, and one symptom (energy level; 5.0%) was common across all scales. The PFS, MFSI, and BFI each captured at least one symptom from each of the NCCN domains of CRF.</p><p><strong>Conclusion: </strong>CRF scales are heterogeneous in the content they measure, critically impairing integration of knowledge across studies using disparate scales. Future work is urgently needed to build more integrated theoretical and/or computational models of CRF based on relevant mechanisms.</p>","PeriodicalId":22046,"journal":{"name":"Supportive Care in Cancer","volume":"32 11","pages":"737"},"PeriodicalIF":2.8,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring the effect of exercise training on breast cancer's pathologic response and tumor immune microenvironment after neoadjuvant chemotherapy. 探索运动训练对乳腺癌新辅助化疗后病理反应和肿瘤免疫微环境的影响。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-21 DOI: 10.1007/s00520-024-08942-0
Helena Guedes, David João, Margarida Caldas, Pedro Antunes, Telma Costa, Alberto Alves, Luísa Helguero, Ana Joaquim

Background: Pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and the percentage of tumor-infiltrating lymphocytes (TILs) are established prognostic biomarkers in early breast cancer (BC). While exercise training is effective as supportive care throughout the BC journey, its impact on the efficacy of NAC is unknown. This study aims to investigate the influence of a supervised exercise training program (SETP) on pCR and TILs in BC women undergoing NAC.

Methods: Retrospective exploratory analysis of the subgroup of BC patients treated with NAC included in a clinical trial randomizing to STEP and control arm. Endpoints were pCR, biopsy, and stromal TILs.

Results: Sixty-four participants were included, with a mean age of 50.3 ± 10.1 years, predominantly stage II and III disease (n = 58, 90.6%), HER2 + (n = 23, 35.9%), or triple-negative (n = 19, 29.7%) tumors. pCR was achieved in 56.7% and 55.9% in the STEP and control arm (p = 0.950). In the STEP arm, median TILs were 5.0 (0.0-80.0) and 5.0 (5.0-30.0), while in the control arm, 5.0 (0.0-90.0) and 0.0 (0.0-30.0) for biopsy and tumor site, respectively. The difference in TILs between arms was 0.04 (confidence interval (CI 95%) - 13.6, 13.7; p = 0.995) and - 4.3 (CI 95% - 11.5, 2.9; (p = 0.233) for biopsy and tumor site, respectively. No statistically significant difference was discerned between the groups concerning TILs of the biopsy. However, a marginally higher TIL level at the tumor site was associated with the SETP arm.

Conclusions: No differences were discerned within and between groups on both pCR and TILs, in possible relation to the exploratory nature of the analysis. Future adequately powered research is warranted.

背景:新辅助化疗(NAC)后的病理完全反应(pCR)和肿瘤浸润淋巴细胞(TIL)的百分比是早期乳腺癌(BC)的既定预后生物标志物。虽然运动训练在乳腺癌的整个治疗过程中都是有效的支持性治疗,但它对 NAC 疗效的影响尚不清楚。本研究旨在调查接受NAC治疗的BC女性中,有监督的运动训练计划(SETP)对pCR和TILs的影响:方法:对一项临床试验中接受 NAC 治疗的 BC 患者亚组进行回顾性探索分析,随机分为 STEP 组和对照组。终点为pCR、活检和基质TILs:64名参与者的平均年龄为(50.3±10.1)岁,主要为II期和III期疾病(58人,占90.6%)、HER2+(23人,占35.9%)或三阴性(19人,占29.7%)肿瘤。在 STEP 治疗组,活检和肿瘤部位的 TIL 中位数分别为 5.0(0.0-80.0)和 5.0(5.0-30.0),而对照组分别为 5.0(0.0-90.0)和 0.0(0.0-30.0)。活检和肿瘤部位的 TILs 差异分别为 0.04(置信区间 (CI 95%) - 13.6, 13.7; p = 0.995)和 - 4.3(CI 95% - 11.5, 2.9; (p = 0.233))。在活检的 TILs 方面,各组之间没有发现明显的统计学差异。然而,SETP组肿瘤部位的TIL水平略高:结论:在pCR和TIL方面,组内和组间均未发现差异,这可能与分析的探索性有关。未来有必要进行充分的研究。
{"title":"Exploring the effect of exercise training on breast cancer's pathologic response and tumor immune microenvironment after neoadjuvant chemotherapy.","authors":"Helena Guedes, David João, Margarida Caldas, Pedro Antunes, Telma Costa, Alberto Alves, Luísa Helguero, Ana Joaquim","doi":"10.1007/s00520-024-08942-0","DOIUrl":"10.1007/s00520-024-08942-0","url":null,"abstract":"<p><strong>Background: </strong>Pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and the percentage of tumor-infiltrating lymphocytes (TILs) are established prognostic biomarkers in early breast cancer (BC). While exercise training is effective as supportive care throughout the BC journey, its impact on the efficacy of NAC is unknown. This study aims to investigate the influence of a supervised exercise training program (SETP) on pCR and TILs in BC women undergoing NAC.</p><p><strong>Methods: </strong>Retrospective exploratory analysis of the subgroup of BC patients treated with NAC included in a clinical trial randomizing to STEP and control arm. Endpoints were pCR, biopsy, and stromal TILs.</p><p><strong>Results: </strong>Sixty-four participants were included, with a mean age of 50.3 ± 10.1 years, predominantly stage II and III disease (n = 58, 90.6%), HER2 + (n = 23, 35.9%), or triple-negative (n = 19, 29.7%) tumors. pCR was achieved in 56.7% and 55.9% in the STEP and control arm (p = 0.950). In the STEP arm, median TILs were 5.0 (0.0-80.0) and 5.0 (5.0-30.0), while in the control arm, 5.0 (0.0-90.0) and 0.0 (0.0-30.0) for biopsy and tumor site, respectively. The difference in TILs between arms was 0.04 (confidence interval (CI 95%) - 13.6, 13.7; p = 0.995) and - 4.3 (CI 95% - 11.5, 2.9; (p = 0.233) for biopsy and tumor site, respectively. No statistically significant difference was discerned between the groups concerning TILs of the biopsy. However, a marginally higher TIL level at the tumor site was associated with the SETP arm.</p><p><strong>Conclusions: </strong>No differences were discerned within and between groups on both pCR and TILs, in possible relation to the exploratory nature of the analysis. Future adequately powered research is warranted.</p>","PeriodicalId":22046,"journal":{"name":"Supportive Care in Cancer","volume":"32 11","pages":"739"},"PeriodicalIF":2.8,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Multi-day vs single-day dexamethasone for the prophylaxis of chemotherapy-induced nausea and vomiting: systematic review and meta-analysis. 用于预防化疗引起的恶心和呕吐的多日地塞米松与单日地塞米松:系统综述和荟萃分析。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-21 DOI: 10.1007/s00520-024-08934-0
Ronald Chow, Luigi Celio, James Im, Saverio Caini, Lawson Eng, Elizabeth Prsic, Florian Scotté, Matti Aapro

Introduction: Over the past decade, several randomized controlled trials have compared single-day dexamethasone (dexamethasone-sparing) regimens to the current standard multi-day dexamethasone antiemetic regimen for chemotherapy-induced nausea and vomiting (CINV). The aim of this systematic review and meta-analysis is to compare the efficacy and safety of dexamethasone-sparing regimens to standard multi-day dexamethasone, used for the prophylaxis of CINV.

Methods: Ovid Medline and Embase were searched from database inception to March 2024. Studies were included if they reported on randomized controlled trials of adult cancer patients receiving different scheduling of dexamethasone, for the endpoints of complete response, complete control, no nausea, no vomiting, and no use of rescue medication. Safety was also assessed. Meta-analysis, leave-one-out meta-analysis, and cumulative meta-analysis were conducted to generate summary effect estimates and assess the influence of single trials on the summary effect estimate.

Results: Ten trials reporting on 2234 patients were included. Dexamethasone-sparing regimens were found to be no different to control arm in the acute (Risk Ratio [RR] 1.01; 95% CI, 0.94-1.08), delayed (RR 0.97; 95% CI, 0.89-1.05) and overall phases (RR 0.98; 95% CI, 0.90-1.06) for complete response. There was likewise no difference for complete control, no nausea, no vomiting, and no use of rescue medication. Safety profile was similar. There was no concern for bias in the published literature. No difference was found between studies reporting on anthracycline/cyclophosphamide-based highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).

Conclusion: In this comprehensive systematic review and meta-analysis, dexamethasone-sparing regimens were found to be no different to current multi-day regimens with respect to efficacy and safety for MEC and anthracycline/cyclophosphamide-based regimens. Clinicians and future guidelines should strongly consider greater adoption and endorsement of dexamethasone-sparing regimens.

简介:在过去十年中,多项随机对照试验对单日地塞米松(地塞米松保留方案)和目前标准的多日地塞米松止吐方案进行了比较,以治疗化疗引起的恶心和呕吐(CINV)。本系统综述和荟萃分析的目的是比较地塞米松稀释方案与用于预防 CINV 的标准多日地塞米松方案的有效性和安全性:方法:对 Ovid Medline 和 Embase 数据库中从开始到 2024 年 3 月的内容进行检索。如果研究报告了成年癌症患者接受不同剂量地塞米松治疗的随机对照试验,并以完全应答、完全控制、无恶心、无呕吐和未使用抢救药物为终点,则纳入该研究。此外,还对安全性进行了评估。研究人员进行了荟萃分析、剔除荟萃分析和累积荟萃分析,以得出总效应估计值,并评估单项试验对总效应估计值的影响:结果:共纳入了10项试验,报告了2234名患者的情况。在急性期(风险比[RR] 1.01;95% CI,0.94-1.08)、延迟期(RR 0.97;95% CI,0.89-1.05)和总体期(RR 0.98;95% CI,0.90-1.06),地塞米松保留治疗方案与对照组在完全应答方面没有差异。同样,在完全控制、无恶心、无呕吐和不使用抢救药物方面也没有差异。安全性情况相似。已发表的文献中不存在偏倚问题。以蒽环类/环磷酰胺为基础的高致呕吐化疗(HEC)和中度致呕吐化疗(MEC)的研究报告之间未发现差异:在这项全面的系统综述和荟萃分析中发现,在MEC和以蒽环类/环磷酰胺为基础的化疗方案中,地塞米松保留方案在疗效和安全性方面与目前的多日方案没有区别。临床医生和未来的指南应大力考虑更多地采用和认可地塞米松保留方案。
{"title":"Multi-day vs single-day dexamethasone for the prophylaxis of chemotherapy-induced nausea and vomiting: systematic review and meta-analysis.","authors":"Ronald Chow, Luigi Celio, James Im, Saverio Caini, Lawson Eng, Elizabeth Prsic, Florian Scotté, Matti Aapro","doi":"10.1007/s00520-024-08934-0","DOIUrl":"10.1007/s00520-024-08934-0","url":null,"abstract":"<p><strong>Introduction: </strong>Over the past decade, several randomized controlled trials have compared single-day dexamethasone (dexamethasone-sparing) regimens to the current standard multi-day dexamethasone antiemetic regimen for chemotherapy-induced nausea and vomiting (CINV). The aim of this systematic review and meta-analysis is to compare the efficacy and safety of dexamethasone-sparing regimens to standard multi-day dexamethasone, used for the prophylaxis of CINV.</p><p><strong>Methods: </strong>Ovid Medline and Embase were searched from database inception to March 2024. Studies were included if they reported on randomized controlled trials of adult cancer patients receiving different scheduling of dexamethasone, for the endpoints of complete response, complete control, no nausea, no vomiting, and no use of rescue medication. Safety was also assessed. Meta-analysis, leave-one-out meta-analysis, and cumulative meta-analysis were conducted to generate summary effect estimates and assess the influence of single trials on the summary effect estimate.</p><p><strong>Results: </strong>Ten trials reporting on 2234 patients were included. Dexamethasone-sparing regimens were found to be no different to control arm in the acute (Risk Ratio [RR] 1.01; 95% CI, 0.94-1.08), delayed (RR 0.97; 95% CI, 0.89-1.05) and overall phases (RR 0.98; 95% CI, 0.90-1.06) for complete response. There was likewise no difference for complete control, no nausea, no vomiting, and no use of rescue medication. Safety profile was similar. There was no concern for bias in the published literature. No difference was found between studies reporting on anthracycline/cyclophosphamide-based highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).</p><p><strong>Conclusion: </strong>In this comprehensive systematic review and meta-analysis, dexamethasone-sparing regimens were found to be no different to current multi-day regimens with respect to efficacy and safety for MEC and anthracycline/cyclophosphamide-based regimens. Clinicians and future guidelines should strongly consider greater adoption and endorsement of dexamethasone-sparing regimens.</p>","PeriodicalId":22046,"journal":{"name":"Supportive Care in Cancer","volume":"32 11","pages":"736"},"PeriodicalIF":2.8,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating a digital tool for supporting people affected by breast cancer: a prospective randomized controlled trial-the ADAPT study. 评估支持乳腺癌患者的数字工具:前瞻性随机对照试验--ADAPT 研究。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-21 DOI: 10.1007/s00520-024-08923-3
Noelle J M C Vrancken Peeters, Olga Husson, Rafal Kulakowski, Emma Hainsworth, Emma Lidington, Sophie E McGrath, Jillian Noble, Leyla Azarang, Susanne Cruickshank, Sofia Georgopoulou

Purpose: This study reports the findings from the ADAPT randomized controlled trial (RCT), concerning the impact of a digital tool for supported self-management in people affected by breast cancer on patient activation as the primary outcome, with health-related quality of life (HRQoL), and health status as secondary outcomes.

Methods: Women with early-stage breast cancer were randomly assigned to standard care (control) or standard care in addition to the breast cancer digital tool (intervention). Data were collected using a demographic questionnaire, the Patient Activation Measure (PAM-13), the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), and the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline, 6 weeks, 3 months, 6 months, and 1 year from diagnosis. Linear mixed effect model regression was used to assess the effect of the digital tool over the first year from diagnosis while correcting for intra-participant correlation.

Results: A total of 166 participants were included, with 85 being randomized into the intervention. No significant differences (p > 0.05) in the PAM-13 scores, EORTC QLQ-C30 scales (global QoL, physical functioning, emotional functioning, pain, fatigue), and EQ-5D-5L Index between the control and intervention groups were observed. It is important to note that there was significant non-adherence within the intervention group.

Conclusion: The breast cancer digital tool had no statistically significant impact on patient activation, HRQoL, and health status over time compared to standard care alone in women with early-stage breast cancer. Future research should focus on identifying and addressing barriers to digital tool engagement to improve efficacy. Clinical trial information The study was registered at https://clinicaltrials.gov (NCT03866655) on 7 March 2019 ( https://clinicaltrials.gov/study/NCT03866655 ).

目的:本研究报告了ADAPT随机对照试验(RCT)的结果,该试验以支持乳腺癌患者自我管理的数字工具对患者积极性的影响为主要结果,以健康相关生活质量(HRQoL)和健康状况为次要结果:方法:患有早期乳腺癌的妇女被随机分配到标准护理(对照组)或标准护理外加乳腺癌数字工具(干预组)。在基线期、确诊后 6 周、3 个月、6 个月和 1 年时,使用人口统计学问卷、患者激活测量(PAM-13)、欧洲癌症研究和治疗组织核心生活质量问卷(EORTC QLQ-C30)和 EuroQol 5 维 5 级问卷(EQ-5D-5L)收集数据。采用线性混合效应模型回归评估数字工具在确诊后第一年内的效果,同时校正参与者之间的相关性:共有 166 名参与者参与了研究,其中 85 人被随机纳入干预方案。对照组和干预组的 PAM-13 评分、EORTC QLQ-C30 量表(整体 QoL、身体功能、情绪功能、疼痛、疲劳)和 EQ-5D-5L 指数均无明显差异(P > 0.05)。值得注意的是,干预组存在严重的不依从现象:结论:与单纯的标准护理相比,乳腺癌数字化工具对早期乳腺癌女性患者的积极性、HRQoL和健康状况没有明显的统计学影响。未来的研究应侧重于识别和解决数字工具参与的障碍,以提高疗效。临床试验信息 该研究于2019年3月7日在https://clinicaltrials.gov(NCT03866655)上注册 ( https://clinicaltrials.gov/study/NCT03866655 )。
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引用次数: 0
Usefulness of urine dipstick test in the management of adverse events associated with immune checkpoint inhibitors. 免疫检查点抑制剂相关不良事件处理中尿液浸量检测的实用性。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-18 DOI: 10.1007/s00520-024-08928-y
Keishiro Izumi, Tomokazu Iyoda, Atsuko Yokota, Masahito Kanno, Masahiro Hoshi, Emi Tokuda, Eisaku Sasaki, Kenya Kanazawa, Junko Kuroda, Shigehira Saji

Purpose: The usefulness of urine dipstick tests (UDTs) in patients with diabetes has been reported. The aim of the present study was to investigate the utility of self-performed UDTs and patient diaries in the management of impaired glucose tolerance, one of the adverse events of immune checkpoint inhibitors (ICIs).

Methods: Patients receiving ICIs underwent self-checks with UDTs twice a week for up to 6 months. Pharmacists checked the results at every patient visit, and by phone every 3 months. The primary endpoint was to prospectively assess whether symptoms recorded in patient diaries and UDTs could reduce unscheduled hospital admissions due to impaired glucose tolerance. The secondary endpoint was the correlation between the symptoms in the patient diaries and UDT results.

Results: A total of 112 patients were enrolled in the study. Out of the 3197 planned self-UDTs, 3128 (97.8%) were performed. Forty-four patients (39.3%) were admitted to the hospital, two (1.8%) of whom were admitted due to abnormal glucose tolerance, with one having a positive UDT. There were 46 unscheduled outpatient visits (41.1%), of which five (4.5%) were due to abnormal glucose tolerance symptoms and four were due to a positive UDT. The correlation between descriptions of fatigue or dry mouth in the patient diaries and positive glucose UDTs was 52.4% in sensitivity and 62.4% in specificity.

Conclusion: Self-monitoring of symptoms and self-performing of UDTs could not reduce the emergency hospitalization rate. However, this approach could be effective in the objective monitoring of patient status, especially regarding glucose intolerance occurrences.

目的:有报道称,尿液定量检测(UDTs)对糖尿病患者很有用。本研究旨在探讨自我尿液定量检测和患者日记在管理糖耐量受损(免疫检查点抑制剂(ICIs)的不良反应之一)方面的效用:方法:接受 ICIs 治疗的患者在长达 6 个月的时间内,每周进行两次 UDT 自我检查。药剂师在每次患者就诊时检查结果,每 3 个月通过电话检查一次。主要终点是对患者日记和 UDT 中记录的症状是否能减少因糖耐量受损而导致的计划外入院进行前瞻性评估。次要终点是患者日记中的症状与 UDT 结果之间的相关性:共有 112 名患者参与了研究。在计划进行的 3197 次自我 UDT 中,3128 次(97.8%)已完成。44名患者(39.3%)入院治疗,其中2名患者(1.8%)因糖耐量异常入院,1名患者的UDT呈阳性。计划外门诊 46 人次(41.1%),其中 5 人次(4.5%)因糖耐量异常症状就诊,4 人次因 UDT 阳性就诊。患者日记中关于疲劳或口干的描述与葡萄糖尿定量检测阳性之间的相关性为:灵敏度 52.4%,特异度 62.4%:结论:自我监测症状和自我进行尿糖检测并不能降低急诊住院率。结论:自我监测症状和自我进行尿液定量检测并不能降低急诊住院率,但这种方法可以有效地客观监测患者状态,尤其是葡萄糖不耐受的发生情况。
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引用次数: 0
What individual needs do family caregivers have in palliative home care and how are they supported? A qualitative study of a supportive intervention. 居家姑息关怀中家庭照护者有哪些个人需求,如何为他们提供支持?一项支持性干预的定性研究。
IF 2.8 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-18 DOI: 10.1007/s00520-024-08904-6
Christiane Kreyer, Barbara Stecher, Sabine Pleschberger, Gail Ewing

Purpose: Family caregivers (FCGs) play a pivotal role in supporting patients in palliative care at home. Person-centred support is crucial to prevent negative outcomes; therefore, evidence-based approaches such as the Carer Support Needs Assessment Tool Intervention (CSNAT-I) are promising. To understand more about the delivery of the intervention, the study focuses on documentation of CSNAT-I in practice in Austria to identify which support needs were discussed with the FCGs and the types of support delivered to meet these needs.

Methods: A retrospective analysis of electronic records was conducted, focusing on documented entries related to the delivery of CSNAT-I over a 21-month period (Dec 2019 to Aug 2021). Both qualitative and quantitative methods were employed for data analysis.

Results: The analysis identified a wide spectrum of FCG support needs, categorised into enabling domains related to caregiving for the patient and direct support needs concerning FCGs' own health and well-being. The most frequently documented support needs included 'having time for oneself in the day' and 'dealing with feelings and worries', highlighting the challenges FCGs face in balancing caregiving responsibilities with personal life. Supportive input encompassed advice and information, counselling, education and training, coordination and arrangement, and signposting and referral.

Conclusion: The study stresses the importance of addressing both practical and psychosocial aspects of caregiving, utilising a person-centred approach. Nurses provided comprehensive support mostly directly delivered during their contact with FCGs. CSNAT-I demonstrated flexibility, accommodating the diverse needs of FCGs in different situations, and may contribute to a more supportive care environment.

目的家庭照护者(FCGs)在支持病人在家接受姑息治疗方面发挥着关键作用。以人为本的支持对于预防不良后果至关重要;因此,以证据为基础的方法,如照顾者支持需求评估工具干预(CSNAT-I)很有前景。为了进一步了解该干预措施的实施情况,本研究重点关注奥地利在实践中对 CSNAT-I 的记录,以确定与家庭护理小组讨论了哪些支持需求,以及为满足这些需求提供了哪些类型的支持:研究对电子记录进行了回顾性分析,重点关注 21 个月内(2019 年 12 月至 2021 年 8 月)与 CSNAT-I 实施相关的记录条目。数据分析采用了定性和定量两种方法:分析结果显示,家庭医生小组的支持需求范围广泛,可分为与患者护理相关的扶持领域和与家庭医生小组自身健康和福祉相关的直接支持需求。最常被记录的支持需求包括 "每天有自己的时间 "和 "处理情感和烦恼",这突显了家庭护理小组在平衡护理责任和个人生活方面所面临的挑战。支持性投入包括建议和信息、辅导、教育和培训、协调和安排以及指引和转介:这项研究强调了利用以人为本的方法解决护理工作中的实际问题和社会心理问题的重要性。护士提供了全面的支持,大部分是在与家庭护理小组接触时直接提供的。CSNAT-I显示出灵活性,可满足家庭护理小组在不同情况下的不同需求,并有助于营造一个更具支持性的护理环境。
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引用次数: 0
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Supportive Care in Cancer
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