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癌症幸存者复发恐惧模型的构建与验证研究

Construction and Validation of A Model of Fear of Cancer Recurrence in Cancer Survivors

【作者】 张旭;

【导师】 李小寒;

【作者基本信息】 中国医科大学 , 护理学, 2022, 博士

【摘要】 目的:复发恐惧被证明是癌症幸存者中最常报道的未满足的心理需求之一。本研究首先通过量性研究了解我国主要癌症发病类型幸存者复发恐惧的发生率,并以个体为中心对癌症幸存者复发恐惧发生水平进行分类深入探讨群体间的异质性和影响因素;通过质性研究方法进一步明确癌症幸存者复发恐惧的发展过程,分析复发恐惧发展过程中的各主要阶段及其特点并挖掘复发恐惧的危险和保护因素;基于疾病不确定感理论和恐惧管理理论构建并验证癌症幸存者复发恐惧模型,探讨复发恐惧与各概念因素之间的路径关系。方法:混合型研究方法第一部分:基于潜在剖面分析的癌症幸存者复发恐惧分型及影响因素研究该部分为横断面研究设计,采用按比例分配连续性抽样的方法,选取2021年2月~2021年6月在中国医科大学肿瘤医院住院并接受治疗的肺癌、胃肠道癌、乳腺癌及妇科肿瘤的癌症幸存者按照1:1:1:1的比例进行抽取作为调查对象。研究工具包括:一般资料调查表、疾病不确定感量表、医院焦虑抑郁量表、领悟社会支持量表及癌症复发恐惧量表简版。采用SPSS 24.0统计软件对数据进行录入和预处理,应用SPSS 24.0软件和Mplus 8.3软件对数据进行统计分析,采用潜在剖面分析的方法对癌症幸存者复发恐惧进行分型并探讨其影响因素。第二部分:癌症幸存者复发恐惧发展阶段的质性研究采用质性研究中解释性现象学的研究方法,通过目的性抽样并结合最大差异的抽样策略,根据纳入和排除标准,选取2021年2月~2021年6月在中国医科大学肿瘤医院住院治疗的10例癌症幸存者(样本量以资料饱和为标准)进行面对面的半结构式访谈,应用Giorgi分析法并借助Nvivo11软件对访谈内容进行转录、整理及分析。第三部分:癌症幸存者复发恐惧模型的构建与验证采用量性研究方法,根据按比例分配连续性抽样,选取2021年7月到2021年10月在中国医科大学肿瘤医院住院并接受治疗的肺癌、胃肠道癌、乳腺癌及妇科肿瘤的癌症幸存者按照1:1:1:1的比例进行抽取作为调查对象。研究工具包括:一般资料调查表、疾病不确定感量表(不明确性分量表)、医院焦虑抑郁量表(焦虑分量表)、领悟社会支持量表(家庭支持分量表)、安德森症状评估量表(核心症状分量表)、事件影响量表-修订版及癌症复发恐惧量表简版。以疾病不确定感理论和恐惧管理理论为基础构建癌症幸存者复发恐惧模型并应用Amos 24.0对模型进行拟合、修正、评价及检验,分析各个概念因素之间的相关关系及作用机制。结果:第一部分:基于潜在剖面分析的癌症幸存者复发恐惧分型及影响因素研究研究共对符合纳入和排除标准的研究对象发放问卷400份,其中有效问卷390份,问卷的有效回收率为97.5%。(1)调查的390例癌症幸存者平均年龄为54.39±10.22岁,癌症类型分布为肺癌107例(27.5%)、消化道癌93例(23.8%)、乳腺癌97例(24.9%)及妇科肿瘤93例(23.8%)。(2)癌症幸存者复发恐惧平均得分为16.98±5.35分(存在复发恐惧占比高达76.7%),可能有焦虑和抑郁的癌症幸存者约为70%,存在中等水平疾病不确定感的人数占据了调查样本的89.0%,超过90%的癌症幸存者均能感受到中或高水平的社会支持。(3)通过潜在剖面分析可以将癌症幸存者复发恐惧分为3类:(1)低复发恐惧-外向型(n=76);(2)中复发恐惧-常规型(n=233);(3)高复发恐惧-神经质型(n=81)。(4)单因素分析:三类别在性别、月收入、文化程度、职业状况、主要照顾者、癌症类型、癌症分期及疾病确诊时长方面具有统计学差异(p<0.05)。其中,低复发恐惧-外向型的癌症幸存者对比其他类别文化程度较低、疾病的确诊时间普遍较短并且退休人数所占的比例高。在高复发恐惧-神经质型的癌症幸存者类别中,肺癌的比例为46.9%与其他类别相比处于较高水平。此外,不同复发恐惧类别的癌症幸存者在焦虑、抑郁、疾病不确定感及社会支持等方面均具有显著差异(p<0.001)。(5)多因素分析:构建无序多分类Logistic回归,以低复发恐惧-外向型为参照组,结果显示焦虑和社会支持是中复发恐惧-常规型和高复发恐惧-神经质型的共同预测因子(p<0.05),焦虑水平与复发恐惧间表现为正相关(OR=1.282;1.378),社会支持与复发恐惧负相关(OR=0.948;0.900)。高水平的疾病不确定感是高复发恐惧-神经质型的预测因子(OR=1.078,p=0.012)。收入水平越低发生高复发恐惧-神经质型的可能性越大(OR=10.653,p=0.023)。初中及以下学历者发生低复发恐惧-外向型的概率较大(OR=0.272;0.229)。第二部分:癌症幸存者复发恐惧发展阶段的质性研究本研究所纳入的10名受访者由4名男性和6名女性癌症幸存者组成,其中肺癌3名,消化道癌3名,乳腺癌和妇科肿瘤各2名;平均年龄为51.8岁;治疗方式分别为手术(4/10)、化疗(2/10)、手术和化疗(4/10);存在复发恐惧(≥13)的受访者占比70%(7/10)。对癌症幸存者复发恐惧发展过程中的各个阶段和感受进行归纳和描述发现复发恐惧形成主要分为5个阶段,依次是:(1)激发阶段:包括侵入性思维、疾病症状、等候检查等三个主题;(2)不确定性阶段:包括疾病不确定性、计划不确定性及治疗不确定性等三个主题;(3)情绪困扰阶段:主要表现为各种负面情绪,如焦虑、抑郁、内疚、孤独及崩溃等;(4)应对策略阶段:包括直面和回避两个主题;(5)复发恐惧阶段:包括恐惧的对象和危险及保护因素两个主题。虽然多数癌症幸存者复发恐惧是通过这5个阶段逐渐发展而来,但需要注意的是复发恐惧发展的5个阶段也并非完全固定或缺一不可。第三部分:癌症幸存者复发恐惧模型的构建与验证研究共回收有效问卷277份,问卷有效的回收率为92.3%,满足本研究样本量的要求。(1)癌症幸存者平均年龄为53.77±10.11岁,癌症类型分布为肺癌73例(26.4%)、消化道癌67例(24.2%)、乳腺癌75例(27.1%)及妇科肿瘤62例(22.4%)。(2)Spearman相关分析结果,复发恐惧与焦虑、疾病不确定感、疾病症状及创伤后应激症状等之间存在正相关(r=0.284~0.602);家庭支持与复发恐惧、焦虑、疾病不确定感、疾病症状及创伤后应激症状等之间存在负相关(r=-0.230~-0.582)。(3)Harman单因子检验可以提取4个公因子,而且第一个因子解释的变异量为43.558%,小于50%的临界标准,故本研究不存在明显的共同方法偏差。(4)在本研究中所有潜变量的因子载荷路径均达到显著(p<0.001),并且大多数显变量的标准载荷系数均在0.70以上,平均变异萃取量(Average Variance Extracted,AVE)的取值范围在0.529~0.814,CR值均在0.765~0.929之间,表明本研究数据具有较好的聚合效度。各因子的AVE平方根值均大于它们与其它因子的相关系数值,因而说明研究数据的区别效度良好。(5)癌症幸存者复发恐惧模型路径系数结果:(1)癌症幸存者的家庭支持状况能够显著负向预测其疾病不确定感(β=-0.24,p=0.004)和焦虑(β=-0.37,p<0.001);(2)癌症幸存者的疾病症状能够显著正向预测其疾病不确定感(β=0.18,p=0.011);(3)癌症幸存者的创伤后应激症状能够显著正向预测其疾病不确定感(β=0.38,p<0.001)、焦虑(β=0.30,p<0.001)及复发恐惧(β=0.32,p<0.001);(4)疾病不确定感能够显著正向预测焦虑(β=0.27,p<0.001)和复发恐惧(β=0.37,p<0.001);(5)焦虑能够显著正向预测复发恐惧(β=0.24,p=0.008)。(6)模型的中介效应检验:(1)疾病不确定感和焦虑在家庭支持、疾病症状及创伤后应激症状与复发恐惧之间起多重中介作用;(2)家庭支持、疾病症状及创伤后应激症状与复发恐惧之间存在间接效应;(3)创伤后应激症状还与复发恐惧之间存在直接效应。(7)模型的拟合评价:卡方自由度比值为1.073,CN=258.576>200,RMSEA=0.016<0.05,GFI、AGFI、NFI、IFI、CFI及TLI均大于0.90,代表本研究各评价指标均满足结构方程模型适配度要求。结论:(1)我国癌症幸存者复发恐惧的发生率较高,临床医护人员应该给予足够的重视。(2)潜在剖面分析发现癌症幸存者复发恐惧存在明显的分类特征,提示医护人员在临床实践过程应根据不同类别癌症幸存者的特征采取有针对性的干预措施。(3)对癌症幸存者一般人口学资料(学历、月收入、工作状况及癌症分期)的调查可能有助于识别复发恐惧风险的患者,而癌症幸存者社会心理因素(焦虑、疾病不确定感及社会支持)可以作为减轻或避免复发恐惧发生的干预方向。(4)质性研究揭示了复发恐惧发展的五个阶段分别为:激发阶段、不确定性阶段、情绪困扰阶段、应对策略阶段及复发恐惧阶段。各个阶段都有其不同的特点,根据不同阶段的特点制定或构建相应的干预策略是未来研究的重要方向。(5)癌症幸存者的家庭支持、疾病症状及创伤后应激症状可以通过疾病不确定感和焦虑对复发恐惧产生直接和/或间接的影响。

【Abstract】 Objective: Fear of cancer recurrence(FCR)has been demonstrated to be one of the most frequently reported and unmet psychological needs among cancer survivors.In this study,we firstly understood the incidence of FCR among survivors of major cancer incidence types in China through quantitative studies,and categorized the level of FCR among cancer survivors by individual to deeply explore the heterogeneity and impact factors among groups;further clarified the formation process of FCR among cancer survivors through qualitative research methods,analyzed each major stage of FCR formation process and its characteristics and explored the risk and protective factors of FCR.The model of FCR in cancer survivors was constructed based on Uncertainty In Illness Theory and Terror Management Theory,and the pathway relationship between FCR and various factors was explored.METHODS: A mixed-methods study Part I: FCR typing and impact factors of cancer survivors based on latent profile analysis This part is a cross-sectional study design,using a proportionally assigned stratified random sampling method,cancer survivors of lung cancer,gastrointestinal cancer,breast cancer and gynecologic tumors who were hospitalized and treated in Cancer Hospital of China Medical University from February 2021 to June 2021 were randomly selected as respondents in the ratio of 1:1:1:1.The survey instruments included: General Information Questionnaire,Illness Uncertainty Scale,Hospital Anxiety and Depression Scale,Perceived Social Support Scale and Fear of Recurrence of Cancer Scale short version.SPSS 24.0 statistical software was used to enter and analyze the data,and SPSS 24.0 software and Mplus 8.3 software were applied to statistically analyze the data,and the method of potential profile analysis was used to typify FCR and explore its impact factors.Part II: A qualitative study of FCR among cancer survivors Using the interpretive phenomenological approach in qualitative research,10 cancer survivors hospitalized at the Cancer Hospital of China Medical University from February 2021 to June 2021(sample size was based on data saturation)were selected for face-to-face semi-structured interviews by purposive sampling combined with a maximum difference sampling strategy according to inclusion and exclusion criteria,and the interviews were transcribed,organized and analyzed by applying Giorgi analysis and with the assistance of Nvivo11 software.Part III: Construction and validation of FCR model for cancer survivors Using a quantitative research method,cancer survivors of lung cancer,gastrointestinal cancer,breast cancer and gynecological tumors who were hospitalized and treated at the Cancer Hospital of China Medical University from July 2021 to October 2021 were randomly selected as respondents according to the ratio of 1:1:1:1 based on stratified random sampling by proportional allocation.The survey instruments included: General Information Questionnaire,Illness Uncertainty Scale(Uncertainty Subscale),Hospital Anxiety and Depression Scale(Anxiety Subscale),Perceived Social Support Scale(Family Support Subscale),Anderson Symptom Assessment Scale(Core Symptom Subscale),Impact of Events Scale-Revised and Fear of Cancer Recurrence Scale Short Version.The FCR model for cancer survivors was constructed based on the theoretical basis and Amos 24.0 was applied to fit,modify,evaluate and test the model,and analyze the correlations and mechanisms of effects among the factors.Results: Part I: FCR typing and factors impacting cancer survivors based on latent profile analysis A total of 400 questionnaires were distributed to study participants who met the inclusion and exclusion criteria in this study.A total of 390 valid questionnaires were returned,with a valid questionnaire return rate of 97.5%.(1)The average age of the 390 cancer survivors surveyed was 54.39±10.22 years,and the distribution of cancer types was 107 cases(27.4%)of lung cancer,93 cases(23.8%)of gastrointestinal cancer,97 cases(24.9%)of breast cancer and 93 cases(23.8%)of gynecological tumors.(2)The mean FCR score of cancer survivors was 16.98±5.35(76.7% of cancer survivors had FCR),about 70% of cancer survivors were likely to have anxiety and depression,the number of people with moderate level of illness uncertainty occupied 89.0% of the survey sample,and more than 90% of cancer survivors felt moderate or high level of social support.(3)Potential profile analysis allowed the classification of cancer survivors FCR into three categories:(1)low FCR-extroverted(n=76);(2)medium FCR-regular(n=233);and(3)high FCR-neurotic(n=81).(4)Univariate analysis: The three categories were statistically different in terms of gender,monthly income,education level,occupational status,primary caregiver,cancer type,cancer stage and length of disease diagnosis(P < 0.05).Among them,low-FCRextroverted cancer survivors were less educated,generally had a shorter time to disease diagnosis,and had a higher proportion of retirees than the other categories.In the highFCR-neurotic cancer survivor category,the proportion of lung cancer was 46.9% which was high compared to the other categories.In addition,cancer survivors in different FCR categories had significant differences in anxiety,depression,disease uncertainty and social support(p < 0.001).(5)Multifactor analysis: Unordered multicategorical logistic regression was constructed,and the results showed that anxiety and social support were common predictors for medium FCR-regular and high FCR-neurotic types(P < 0.05),and a positive association was shown between anxiety level and FCR(OR=1.282;1.378),and social support was negatively association(OR=0.948;0.900).High levels of illness uncertainty were a predictor of high FCR-neuroticism(OR=1.078,p=0.012).The lower the income level the greater the likelihood of occurrence of high FCR-neurotic type(OR=10.653,P=0.023).The probability of occurrence of low FCR-extroverted type was greater in those with junior high school or lower education(OR=0.272;0.229).Part II: A qualitative study of FCR in cancer survivors The 10 respondents included in this study consisted of 4 male and 6 female cancer survivors,including 3 with lung cancer,3 with gastrointestinal cancer,and 2 each with breast cancer and gynecologic tumors;mean age was 51.8 years;treatment modalities were surgery(4/10),chemotherapy(2/10),and surgery and chemotherapy(4/10);and 70%(7/10)of respondents had FCR(≥13).The stages and feelings of cancer survivors in the process of FCR formation were summarized and described,and it was found that FCR formation was mainly divided into five stages,in order:(1)the triggering stage included three themes,such as intrusive thinking,disease symptoms and waiting for examination;(2)the uncertainty stage included three themes,such as illness uncertainty,planning uncertainty and treatment uncertainty;(3)the emotional distress stage was mainly manifested by various negative,such as anxiety,depression,guilt,loneliness,and breakdown;(4)the coping strategy stage includes two themes,namely,confrontation and avoidance;(5)the FCR stage includes two themes,namely,the object of fear and risk and protective factors.Although most cancer survivors develop FCR gradually through these five stages,it should be noted that the five stages of FCR formation are not completely fixed or missing.Part III: Construction and validation of FCR model for cancer survivors A total of 277 valid questionnaires were collected in the study,and the valid questionnaire return rate was 92.3%,which satisfied the sample size requirement of this study.(1)The mean age of cancer survivors was 53.77±10.11 years,and the distribution of cancer types were 73 cases(26.4%)of lung cancer,67 cases(24.2%)of gastrointestinal cancer,75 cases(27.1%)of breast cancer and 62 cases(22.4%)of gynecological tumors.(2)Spearman’s correlation analysis showed that there was a positive correlation between FCR and anxiety,illness uncertainty,disease symptoms and post-traumatic stress symptoms(r=0.284-0.602);there was a negative correlation between family support and FCR,anxiety,illness uncertainty,disease symptoms and post-traumatic stress symptoms(r=-0.230-0.582).(3)Harman one-way test could extract four common factors,and the variance explained by the first factor was 43.558%,which was less than the critical criterion of 50%,thus there was no significant common method bias in this study.(4)The factor loading paths of all latent variables in this study reached significance(p < 0.001),and the standard loading coefficients of most of the significant variables were above 0.70,and the values of Average Variance Extracted(AVE)ranged from 0.529 to 0.814,and the CR values range from 0.765 to 0.929,indicating excellent convergent validity of the scale data.The AVE square root values of each factor were greater than their correlation coefficient values with other factors,thus indicating good discriminant validity of the study scale data.(5)The results of the path coefficients of the FCR model for cancer survivors:(1)family support status of cancer survivors significantly and negatively predicted their illness uncertainty(β=-0.24,P=0.004)and anxiety(β=-0.37,P<0.001);(2)disease symptoms of cancer survivors significantly and positively predicted their illness uncertainty(β=0.18,P=0.011);and(3)post-traumatic stress symptoms of cancer survivors significantly and positively predicted their illness uncertainty(β=0.38,P<0.001),anxiety(β=0.30,P<0.001)and recurrence.post-traumatic stress symptoms of cancer survivors significantly and positively predicted their disease uncertainty(β=0.38,P<0.001),anxiety(β=0.30,P<0.001)and FCR(β=0.32,P<0.001);(4)illness uncertainty significantly and positively predicted anxiety(β=0.27,P<0.001)and FCR(β=0.37,P <0.001);(5)anxiety could significantly and positively predict FCR(β=0.24,P=0.008).(6)The mediating effects of the model were tested:(1)illness uncertainty and anxiety played multiple mediating roles between family support,disease symptoms and posttraumatic stress symptoms and FCR;(2)there were indirect effects between family support,disease symptoms and post-traumatic stress symptoms and FCR;(3)there were also direct effects between post-traumatic stress symptoms and FCR.(7)Fit evaluation of the model: the chi-square degrees of freedom ratio was 1.073,CN=258.576>200,RMSEA=0.016<0.05,GFI,AGFI,NFI,IFI,CFI and TLI were all greater than 0.90,representing that all evaluation indexes of this study met the requirements of structural equation model fitness.Conclusion:(1)The incidence of FCR among cancer survivors in China is high,and clinical health care professionals should pay sufficient attention to it.(2)The analysis of potential profiles revealed obvious categorical characteristics of cancer survivor FCR,suggesting that health care professionals should adopt targeted interventions according to the characteristics of different categories of cancer survivors in the clinical practice process.(3)Investigation of general demographic information(education,monthly income,work status and cancer stage)of cancer survivors may help identify patients at risk of recurrence fear,while psychosocial factors(anxiety,disease uncertainty and social support)of cancer survivors may serve as intervention directions to mitigate or avoid the occurrence of recurrence fear.(4)The qualitative study revealed five stages of FCR formation: triggering stage,uncertainty stage,emotional distress stage,coping strategy stage,and FCR stage,respectively.Each stage has its own characteristics,and formulating or constructing corresponding intervention strategies according to the characteristics of different stages is an important direction for future research.(5)Family support,disease symptoms and post-traumatic stress symptoms in cancer survivors can have between or/and indirect effects on FCR through disease uncertainty and anxiety.

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