The Development And Validation Of A Patient-Reported Outcome Tool To Assess Financial Toxicity Among Older Cancer Survivors

BackgroundIn China,there was an estimated 4.6 million new cancer cases and 3.0 million cancer deaths in 2020.Approximately 60%of all cancers and 70%of cancer mortality occurred in persons aged 60 years or over,making cancer the leading cause of death and a major economic burden in recent years.Although the new therapies prolonged life span and improved quality of life,they led to rising cancer medical expenditure with expected increases in cancer prevalence.The high cost of medicine and completion of treatment after a cancer diagnosis imposes substantial financial toxicity on older cancer patients and their families.Many studies highlighted issues related to the cost of cancer treatment and the economic burden of cancer,its treatment,and the lasting effects of treatment.Older patients with cancer generally experience cancer survivorship differently compared to younger adults with cancer.Patients’ age and life stage might affect the trajectory and consequences of their cancer-related financial toxicity.Each stage of life comes with its own unique demands,stresses,and resources,which can change as individuals move in and out of work and family roles.This may have an impact on patients’ financial stability and their ability to cope with financial distress resulting from catastrophic diseases.Generally,older cancer patients and their family caregivers are presented with complex information regarding the risks and benefits of cancer treatment,but financial concerns are not thoroughly discussed with oncologists.In addition,filial piety is a crucial mechanism that affects the cancer care of older parents in Chinese Confucian culture.Patients’ family caregivers are critically important in providing supportive care and decision-making during and after cancer treatment.However,financial toxicity among older cancer survivors has not been well-studied,despite its debilitating effects on their health and well-being.In order to alleviate economic burdens for older adults with cancer and their families in China,it is essential to gain a thorough understanding of cancer-related financial toxicity and its effects.Exploring and quantifying cancer patients’ and their families’ experiences of financial toxicity can help inform care provision,health policy,and further interventions for elderly patients struggling with their financial toxicity.ObjectivesTherefore,the general goal of this study was to describe and then to quantify the lived experiences of financial toxicity of Chinese older cancer survivors following a cancer diagnosis,with an emphasis on strategies to anticipate and reduce its burden.1.To describe the lived experiences related to the financial impacts of a cancer diagnosis among older cancer survivors from family perspectives;2.To develop an instrument to quantitatively measure older cancer patients’ experience related to financial toxicity;3.To assess the validity and reliability of this instrument and to measure financial toxicity using this instrument in Chinese health care systems;4.To give some recommendations and strategies to reduce financial toxicity at multiple levels.Research contents and methodsTo more fully understand patients’ lived experiences over the cancer trajectory,we used mixed method to explore financial toxicity among older adults with cancer,which can provide robust evidence and a comprehensive understanding of this phenomenon.This study is divided into three stages:1.In the first stage,using descriptive phenomenological methods,21 older cancer patients,20 family caregivers,and 6 oncologists and 8 nurses were interviewed in depth with targeted sampling to explore the experience of cancer-related financial toxicity.And then we described the lived experiences related to the financial impacts of a cancer diagnosis among older cancer survivors,and finally developed a conceptual framework,which can provide the theoretical basis and prerequisite for the next stage study.2.The second stage was to construct a patient-reported outcome tool to assess financial toxicity in older cancer patients.The original item pool was first constructed through multiple sources such as qualitative interview and literature search,and then the items were preliminarily evaluated and screened.Items were screened based on two rounds of Delphi expert(N=19)consultation and item importance evaluation by patients(N=40).Then,cluster sampling method was adopted to recruit 205 elderly cancer patients who met the criteria of inclusion in two hospitals in Shandong Province.We used critical ration,reliability analysis,correlation coefficient,item difficulty parameter,item discrimination parameter,item characteristic curve,item and scale characteristic function,exploratory factor analysis were used to develop financial toxicity assessment tool for elderly cancer patients.3.The third stage was to validate this patient-reported outcome tool to assess financial toxicity in older cancer survivors.We recruited 518 samples who met the inclusion criteria from three hospitals in Shandong Province by cluster sampling method.We used confirmatory factor analysis,gender equivalence test,reliability and validity evaluation to test the validation.Mean and standard deviation were used to describe the financial toxicity score,frequency and frequency distribution were used to describe the distribution characteristics of each item.With poor quality of life(N=129)as the health outcome,the financial toxicity score was divided into higher financial toxicity and lower financial toxicity.Finally,multivariable logistic regression model was used to examine the relationship between cancer survivors’ characteristics and higher financial toxicity.Results1.Qualitative research resultsFour main themes emerged:(1)older survivors have insufficient ability to address cancerrelated costs;(2)financial transfers from adult children to older parents became prevalent after a cancer diagnosis;(3)cancer-related financial worries and stress extended into children’s families;(4)coping and adjustment strategies were used by the extended family.Traditional Confucian culture and the Chinese health care system considerably impacted the interpretation of financial toxicity.2.Tool development research resultsIn item generation step,a literature review yielded 60 candidate items.Then,21 patients and 20 family caregivers were interviewed,and they generated 43 candidate items.6 oncology physicians and nurses then generated an additional 12 items.These 135 items were reduced to 60 by the investigators because of redundancy,overlapping content,and problematic language.In item importance step,a preliminary list of items was vetted through expert consensus opinion by correspondences.29 items were selected for next steps.Patients consented to evaluate the 29 items for importance to themselves,and 24 items were retained.In item analysis step,the CTT-based item evaluation suggested that,except item-8,the resolution coefficient does not indicate item deletion,and each item has good discrimination;the correlation coefficient method indicated that most items had a good correlation with the total score,and some items had a strong correlation(≥0.7,P<0.01).Cronbach’s α coefficient method indicated that the correlation coefficients of a few items(item-6,item-7 and item-8)were all less than 0.35 after correction,and the coefficients were further improved after deletion.The IRT-based item evaluation showed that the distinction a parameter of majority of items was performed well in discrimination and difficulty;item characteristic curve(ICC),item information function(ⅡF)and scale information function(SIF)were well distributed.Finally,quantitative item analysis excluded 8 items.In exploratory factor analysis step,before performing the factor analysis,the suitability of the data for factoring was assessed.The Kaiser-Meyer-Oklin value was 0.842,and the Bartlett test of sphericity reached statistical significance,supporting the factorability of the items.Two factors were clearly identified on parallel factor analysis,explaining 56%of the variance.The 10-item financial toxicity-PROM was developed.3.Tool validation research resultsThe results of confirmatory factor analysis(CFA)showed that the tool had good structural validity,the loading of each factor ranged from 0.54 to 0.89,and the model fitting index was ideal(RMSEA=0.08,SRMR=0.04,GFI=0.96,CFI=0.96).The Cronbach’s α coefficients of the total score and each dimension scores ranged from 0.84 to 0.87.The split-half reliability of the scale and its dimensions ranged from 0.68 to 0.88,and the retest reliability was 0.91.The correlation coefficient between the total score of COST scale and the total score of this measuring tool was 0.52(P<0.01).Based on Bonferroni method,there was no statistical difference between the total score and the Factor 1 score among different response types.The score of Factor 2 from patients’ self-reported responses was lower than that in patient and caregiver’shared responses(P<0.05).4.Quantitative research resultsThe AUC value was 0.65(95%CI:0.60-0.70),which indicates an acceptable performance of the prediction.The ROC analysis results suggested that a cut-off score of 18.5 could provide a balance between acceptable levels of sensitivity(0.64)and specificity(0.59).When the sample was stratified based on this cut-off score,42%of elderly patients were assessed as having higher financial toxicity and 58%as having lower financial toxicity.Using stepwise selection method of selection of the independent variable in Logistic regression model,the influencing factors are:socioeconomic status(employment,family income,educational level and health insurance),social support,loneliness,frailty status,cancer site,out-of-pocket health care costs and medical decision-making patterns.ConclusionsThe main findings of the study were as follows:1.This study shed light on the financial distress experienced by several older cancer patients and their families,and how they coped and adjusted.We found that older cancer survivors’ experiences of financial toxicity varied depending on filial care responsibilities and changes in their family’s financial situation along the cancer trajectory.Financial toxicity is potentially devastating consequences of cancer,its treatment,and the lasting effects of treatment that deteriorate the lives of older cancer survivors and their families.2.10-item financial toxicity assessment tools based on patient reported outcome can reflect the specificity of older cancer survivors and their families,has good reliability,validity and feasibility.3.When quality of life was considered as the health outcome,a cut-off score of 18.5 could provide a balance between acceptable levels of sensitivity and specificity,and it had the greatest predictive value for poor quality of life,suggesting that the tool should be used to screen patients with high risk of financial toxicity in clinical practice.4.Some variables such as socioeconomic status(employment,family income,educational level and health insurance),frailty and loneliness,perceived social support,cancer site,and outof-pocket medical expenses of elderly patients are risk factors for high financial toxicity.ImplicationsThese findings call for policy actions and interventions to reduce the burden of at-risk patients with cancer.Our government and society should make a concerted effort to advance cancer health equity and reduce the financial burden of older cancer survivorship.Screening tools for patient-reported financial hardship are currently underdeveloped and need to be adapted to the healthcare system and the individual characteristics of vulnerable older patients to aid in early identification of patients at risk.Strengths and limitationsThis study contributed to a comprehensive understanding of older cancer patients’ and their family members’ individual and shared,rich and nuanced experiences with financial toxicity.This detailed developmental description of this PROM is a first and major step toward measuring how financial toxicity impacts the lives of older patients with cancer and their family in China.At the same time,this study is also an original study in the field of cancer survivorship in China,which will provide evidence for improving the quality of cancer care.The study has some potential limitations.Participant selection bias and reporting bias may have occurred.As a result of our recruitment method through hospital staff,we were unable to reach patients who were not receiving treatment,possibly due to financial difficulty,at the time of cancer diagnosis.We were also unable to reach patients’ family who were died.These individuals may have been more deeply impacted by the effects of financial toxicity than the participants in our study,who had received some form of cancer treatment.Self-reported retrospective experiences may contain inaccuracies due to recall bias.Willingness to share family financial information may depend on the survivors’and caregivers’personal sensitivity and comfort level.Cancer trajectory and seeking medical treatment for survivors are complicated and long term,but this was a cross-sectional study without detailed clinical data in cancer trajectory on the change about survivors over time.Future exploration should focus on the longitudinal impact of cancer survivorship on financial toxicity.