【作者】 马俊；

【导师】 王红红；

【作者基本信息】 中南大学 ， 健康与慢病管理学， 2025， 博士

【摘要】 目的:(1)构建青少年恶性肿瘤患者过渡管理框架;(2)评估我国青少年恶性肿瘤患者过渡准备现状,验证前期构建的概念框架;(3)基于前期研究结果,以骨肉瘤为例,构建适用于青少年恶性肿瘤患者过渡准备的干预方案“过渡期导航计划”;(4)通过实证研究,初步评估过渡期导航计划在提升我国青少年骨肉瘤患者过渡准备的可行性及应用效果。方法:根据研究技术路线,本研究共包含以下4个阶段:(1)青少年恶性肿瘤患者过渡管理框架构建:在现实主义整合方法论的指导下,以现有过渡相关的理论为初始概念框架,从文献证据中挖掘与青少年恶性肿瘤患者过渡相关的情境、机制及结局因素,对初始概念框架进行验证和完善,形成适应本研究的青少年恶性肿瘤患者过渡管理框架。(2)青少年恶性肿瘤患者过渡准备的现状调查:采用横断面研究设计,于2023年3-7月采取便利抽样选取了湖南省4所三甲医院符合纳入排除标准的217例青少年恶性肿瘤患者进行问卷调查。调查指标基于前期构建的过渡管理框架选取,包括一般人口学及临床疾病特征、过渡准备(过渡自我管理问卷)、癌症担忧(癌症担忧量表)、过渡期望(过渡期望量表)、患者积极度(患者积极度量表)、社会支持(领悟社会支持量表)。使用使用SPSS25.0、Rstadio及Mplus;采用多元线性回归分析人口学特征与过渡准备的关联;采用网络结构分析探索过渡准备内部维度间的相关关系;建立中介效应模型,分析情境因素(家庭支持、医疗支持和朋辈支持)-机制因素(过渡期望、癌症担忧、患者积极度)-结局因素(过渡准备4个维度)的相关性,验证前期构建的过渡管理框架。(3)青少年恶性肿瘤患者过渡准备干预方案“过渡期导航计划”的构建:(1)基于前期文献研究及横断面研究结果,优先选择青少年骨肉瘤患者作为干预对象;(2)以干预映射为指导,基于文献回顾、现实主义整合、横断面调查及利益相关者咨询,融入患者导航和游戏化的干预理念,初步拟定适用于青少年骨肉瘤患者过渡准备的干预方案;(3)通过专家评议,修订干预方案,并命名为“过渡期导航计划”。(4)青少年恶性肿瘤患者过渡准备干预方案“过渡期导航计划”的初步应用:采用非随机分配的自然对照设计,采用连续性抽样将湖南省2所综合医院的骨肿瘤科于2024年8月至2025年1月收治的所有新诊断骨肉瘤患者纳入研究,对照组数据在2024年8月到11月收集,干预组数据在2024年10月到2025年1月收集。所有参与者均符合统一的纳排标准。最终对照组招募到27名青少年骨肉瘤患者,干预组招募到32名。对照组的研究对象接受常规护理方案,干预组的研究对象在接受常规护理的基础上,还接受为期约8周的过渡期导航计划的干预,两组患者均接受随访1个月。分别于干预前、干预后即刻、干预后1个月对两组青少年骨肉瘤患者的过渡准备(主要结局指标)、癌症担忧、过渡期望、患者积极度、社会支持(次要结局指标)进行调查。根据CONSORT可行性研究拓展指南的建议,从招募策略、干预实施及数据收集3个层面评估可行性,使用可接受度理论框架通用问卷对干预的可接受度进行评价,采用自行设计的问卷对满意度进行调查。借助SPSS25.0软件进行统计分析,采用广义估计方程分析过渡期导航计划对青少年骨肉瘤患者各结局变量的影响。结果:(1)青少年恶性肿瘤患者过渡管理框架构建:本阶段共纳入27篇高度相关文献作为数据提取的来源。共提取3个情境因素(家庭支持、医疗支持和朋辈支持),3个机制因素(态度及期望、自主性、心理状态),1个结局因素(过渡准备),并生成了多个情境-机制-结局的路径,形成了青少年恶性肿瘤患者过渡管理框架。在形成的过渡管理框架中,青少年恶性肿瘤患者过渡准备包含患者在过渡前对疾病治疗及管理的知识,以及患者进行疾病管理的能力及技巧,包括药物管理、医患沟通及医疗参与3个方面。习得知识和能力的关键作用机制包括提升患者对过渡的期望,在过渡前及过渡过程中对疾病管理的自主性以及心理状态。机制因素和结局受家庭照护者,医护人员及朋辈3个角色所引起的情境因素的影响。(2)青少年恶性肿瘤患者过渡准备的现状调查:(1)217例青少年恶性肿瘤患者过渡准备总分均值为59.95±11.34分;其中疾病知识得分最低,条目均分为2.97±0.93;网络分析结果显示药物管理维度的中心度均低于其他三个维度,而医患沟通和医疗参与(2.22 vs.1.94)是青少年恶性肿瘤患者过渡准备网络结构中最核心的要素;(2)年龄及诊断时长是过渡准备的重要影响因素,年龄越大(t=7.186,P<0.001),诊断时长越长(t=2.268,P=0.024),过渡准备得分越高;此外,诊断时长越长,医患沟通得分越高(t=2.129,P=0.034),已经中断学业的青少年医疗参与得分较低(t=-2.344,P=0.020),与白血病患者相比,骨肉瘤的患者疾病知识得分更低(t=-2.263,P=0.025)。中介效应分析结果显示,医疗支持对疾病知识,药物管理,医疗参与及医患沟通的直接效应不显著(P>0.05),而医疗支持-患者积极度-药物管理/医疗参与/医患沟通/疾病知识这4条简单中介的间接路径效应值分别为0.072、0.114、0.111、0.046,且95%可信区间不包含0,中介效应成立。朋辈支持对疾病知识,药物管理,医疗参与及医患沟通的直接效应不显著(P>0.05),而朋辈支持-患者积极度-药物管理/医疗参与/医患沟通/疾病知识这4条简单中介的间接路径效应值分别为0.082、0.130、0.121、0.053,且95%可信区间不包含0,中介效应成立。此外,朋辈支持还可以通过过渡期望及患者积极度的链式中介作用对医患沟通这一维度产生间接影响,间接效应值为0.009。家庭支持、癌症担忧与过渡准备的4个维度、患者积极度、过渡期望等均不相关。(3)青少年恶性肿瘤患者过渡准备干预方案“过渡期导航计划”构建:(1)基于流行病学特征和前期研究结果,选定骨肉瘤患者为干预对象,构建了针对青少年骨肉瘤患者过渡准备的干预方案;(2)基于名义群体法和剧场测试,进一步对干预方案进行修订。在内容上,从知识、管理技能、过渡期望、癌症担忧及患者积极度多个层面对青少年骨肉瘤患者进行了干预。在形式上,以护理导航员全程引导,以互动式情景游戏为干预策略载体,与骨肉瘤患者实际需求相契合,也符合青少年的认知和兴趣特点,为干预实施提供了可靠的保障。整合“过渡期”和“患者导航项目”的特点,将干预方案命名为“过渡期导航计划”。(4)青少年恶性肿瘤患者过渡准备干预方案“过渡期导航计划”初步应用:(1)过渡期导航计划的可行性和可接受性评估:过渡导航计划在招募率(81.9%)、干预完成率(84.4%)、随访完成率(100%)及问卷资料完整性方面表现良好,具备良好的实施可行性。干预后,可接受度在情感态度、伦理适配性、感知有效性、自我效能等多个维度均显著提升(P均<0.05),总体可接受度提升0.78分(P<0.001),表明过渡导航计划受到患者高度认可。满意度调查亦显示所有患者均认为该项目有帮助、内容重要且具有趣味性,干预形式和人员互动整体获得积极评价。综合结果验证了本干预在目标人群中的适宜性和推广潜力。(2)过渡期导航计划的初步有效性:过渡期导航计划能有效提高青少年骨肉瘤患者的过渡准备,组间比较结果显示在干预结束时和干预后1个月,对照组过渡准备得分较干预组分别低8.834(P<0.001)和-7.972(P=0.001);组内比较结果显示干预组在干预结束时的过渡准备得分较基线时高6.74分(P<0.001),干预组在干预后1个月的过渡准备得分较基线时高7.52分(P<0.001)。对过渡准备的各维度得分进行进一步分析,组间比较结果显示在干预结束时和干预后一个月,药物管理、医患沟通及疾病知识得分均低于干预组(P<0.05);组内比较结果干预组干预结束时的医疗参与、医患沟通和疾病知识均显著高于基线(P<0.05);并且在干预结束后1个月,医患沟通和疾病知识得分与基线间的差异仍有统计学意义(P<0.05);过渡期导航计划对医疗参与维度的干预效果不显著。其次,过渡期导航计划能有效改善青少年骨肉瘤患者积极度、医疗支持及朋辈支持,但对癌症担忧、过渡期望及家庭支持的效果不显著。结论:(1)青少年恶性肿瘤患者过渡管理框架明确了过渡准备的核心要素,包括疾病知识,药物管理、医患沟通和医疗参与能力,并识别了提升过渡期望、自主性和心理状态的关键机制及家庭、医护人员和朋辈层面的情境因素,并厘清了情境-机制-结局之间的作用路径,为未来的过渡准备干预方案的构建提供了理论指导。(2)青少年恶性肿瘤患者过渡准备现状不佳,其中疾病知识严重不足,而医患沟通和医疗参与在网络结构分析中中心性更高,是提升过渡准备的核心维度。患者积极度是过渡准备的重要中介变量,医疗支持和朋辈支持通过患者积极度对过渡准备产生间接效应,均对提升过渡准备起到关键作用。(3)本研究干预方案的构建过程,将心理建设、行为激励、知识教育和技能训练相结合,形成一个全面的支持体系;采用具备专业的肿瘤护理知识,且为患者及家属熟悉的肿瘤科护士作为导航员,进行全程引导,并将干预策略进行游戏化呈现,形成的过渡期导航计划兼具可靠性和实践意义。(4)患者、照护者及导航员对过渡期导航计划的内容和形式均表示认可,接受度和满意度较高,过渡期导航计划具有科学性、新颖性、趣味性等优势;过渡期导航计划可以有效地改善青少年骨肉瘤患者的过渡准备、患者积极度、医疗支持和朋辈支持,但对医疗参与、癌症担忧、过渡期望及家庭支持无显著效果;本研究结果为其他类型的青少年恶性肿瘤患者过渡准备干预方案构建提供参考,也为未来大规模随机对照试验的进行提供了实证依据。图24幅,表44个,参考文献234篇更多还原

【Abstract】 Objectives:(1)To construct a conceptual framework of transition readiness for adolescent patients with malignant tumors.(2)To evaluate the current status of transition readiness among Chinese adolescents with malignant tumors and validate the proposed framework.(3)To develop a transition navigation program tailored to adolescent patients with malignant tumors—taking osteosarcoma as a representative case—based on the previous findings.(4)To conduct a pilot study to preliminarily assess the effectiveness of the navigation program in improving transition readiness among adolescent osteosarcoma patients.Methods:According to the technical roadmap,this study was conducted in four stages:(1)Construction of the Transition Management Framework:Guided by the realist synthesis methodology,a preliminary conceptual framework was developed based on existing theories and refined through literature synthesis.This process identified relevant contextual,mechanistic,and outcome factors associated with the transition of adolescents with malignant tumors,forming the basis of the transition management framework.(2)Cross-sectional Survey on Transition Readiness:A cross-sectional study was conducted from March to July 2023 across four tertiary hospitals in Hunan Province,involving 217 eligible adolescent cancer patients selected via convenience sampling.Data collection tools included questionnaires assessing demographic and clinical characteristics,transition readiness(Transition Readiness Questionnaire),cancer-related worry(Cancer Worry Scale),transition expectations,patient activation(Patient Activation Measure),and perceived social support.Statistical analyses were performed using SPSS 25.0,RStudio,and Mplus,including multiple linear regression,network analysis,and mediation modeling to examine associations and validate the framework.(3)Development of the Transition Navigation Program:Based on the epidemiological profile and cross-sectional findings,adolescent osteosarcoma patients were selected as the target population.Using the Intervention Mapping approach,a game-based,patient-navigation-inspired intervention was designed through literature review,stakeholder consultation,and expert panel evaluation.The program content addressed disease knowledge,management skills,cancer-related worry,transition expectations,and patient activation.(4)Application of the Navigation Program:A non-randomized natural control trial was implemented from August 2024 to January 2025 at two tertiary hospitals in Hunan.Patients diagnosed with osteosarcoma were divided into control and intervention groups based on clinical department clusters.The control group received routine care,while the intervention group participated in the navigation program for approximately 8 weeks in addition to standard care.Outcomes—including transition readiness(primary outcome),cancer worry,transition expectations,patient activation,and social support(secondary outcomes)—were measured at baseline,immediately post-intervention,and at 1-month follow-up.Feasibility was evaluated following the CONSORT extension for feasibility trials,and acceptability was assessed using standardized frameworks and self-designed satisfaction questionnaires.Data were analyzed using Generalized Estimating Equations(GEE)in SPSS 25.0.Results:(1)Transition Management Framework:A total of 27 relevant studies were included to identify 3 contextual factors(family,healthcare,peer support),3 mechanisms(attitudes and expectations,autonomy,psychological state),and 1 outcome(transition readiness).Transition readiness was defined as the accumulation of disease-related knowledge and the development of management skills(medication adherence,medical communication,and engagement).The framework identified critical pathways linking contextual and mechanistic factors to readiness outcomes.(2)Current Status of Transition Readiness:The mean total transition readiness score among 217 participants was 59.95±11.34,with disease knowledge scoring the lowest(2.97±0.93).Network analysis identified medical communication and participation as the most central readiness dimensions.Age and diagnosis duration were significant predictors(older age and longer diagnosis correlated with higher readiness).Osteosarcoma patients scored lower in disease knowledge compared to leukemia patients.Mediation analyses confirmed that patient activation mediated the effects of healthcare and peer support on all readiness dimensions.Family support showed no significant associations.(3)Development of the Transition Navigation Program:Osteosarcoma patients were selected due to their high incidence in adolescents and lower transition readiness observed in earlier findings.The final program included gamified modules,scenario-based learning,and nurse-led guidance.The intervention was structured to align with adolescent cognitive and emotional development.(4)Implementation and Evaluation:Feasibility&Acceptability:The program demonstrated high feasibility with a recruitment rate of 81.9%,intervention completion rate of 84.4%,100%follow-up rate,and no missing data.Acceptability scores significantly improved post-intervention in all dimensions(e.g.,perceived effectiveness,coherence,self-efficacy),with an overall acceptability score of 4.74 out of 5.Satisfaction ratings were uniformly positive,confirming high content and delivery suitability.Preliminary Effectiveness:The navigation program significantly improved transition readiness in the intervention group compared to the control group(mean differences of 8.834 and 7.972 at post-intervention and follow-up,respectively,p<0.001).Improvements were observed particularly in disease knowledge and communication.Patient activation,peer and healthcare support were also significantly enhanced.However,no significant effects were observed on cancer worry,transition expectations,or family support.Conclusions:(1)The constructed framework clarified the multidimensional structure of transition readiness,identified key mechanisms(expectations,autonomy,psychological state),and established evidence-based pathways linking support systems to readiness outcomes.(2)Transition readiness among Chinese adolescents with cancer remains suboptimal,especially in knowledge acquisition.Patient activation emerged as a critical mechanism mediating the effects of support on readiness outcomes.(3)The developed navigation program integrated psychological,behavioral,and educational components with interactive game-based delivery,led by oncology nurses familiar to the patients.This approach demonstrated high feasibility,engagement,and practical applicability.(4)The program was well-received by patients,caregivers,and navigation staff.It effectively improved readiness and support-related outcomes while highlighting areas needing further refinement.These findings support the validity of the proposed framework and lay the groundwork for future large-scale randomized controlled trials.更多还原