38/9 As A Mixed Number
Traumatic stress symptoms in family unit caregivers of patients with acute leukaemia: protocol for a multisite mixed methods, longitudinal, observational study
Abstract
Introduction The diagnosis, progression or recurrence of cancer is often highly traumatic for family unit caregivers (FCs), just systematic assessments of distress and approaches for its prevention and handling are lacking. Acute leukaemia (AL) is a life-threatening cancer of the blood, which most ofttimes presents acutely, requires intensive treatment and is associated with astringent physical symptoms. Consequently, traumatic stress may be common in the FCs of patients with AL. We aim to determine the prevalence, severity, longitudinal class and predictors of traumatic stress symptoms in FCs of patients with AL in the outset year later on diagnosis, and to understand their lived experience of traumatic stress and perceived support needs.
Methods and analysis This two-site longitudinal, observational, mixed methods study volition recruit 223 adult FCs of paediatric or adult patients newly diagnosed with AL from ii 3rd care centres. Quantitative data will be nerveless from cocky-report questionnaires at enrolment, and ane, iii, six, 9 and 12 months after access to hospital for initial treatment. Quantitative information will exist analysed using descriptive and motorcar learning approaches and a multilevel modelling (MLM) approach will be used to confirm auto learning findings. Semi-structured qualitative interviews will be conducted at iii, 6 and 12 months and analysed using a grounded theory approach.
Ideals and dissemination This study is funded by the Canadian Institutes of Wellness Research (CIHR number PJT 173255) and has received upstanding approval from the Ontario Cancer Research Ideals Board (CTO Project ID: 2104). The data generated have the potential to inform the evolution of targeted psychosocial interventions for traumatic stress, which is a public wellness priority for high-risk populations such as FCs of patients with haematological malignancies. An integrated and end-of-report knowledge translation strategy that involves FCs and other stakeholders will be used to interpret and disseminate study results.
- leukaemia
- adult palliative care
- paediatric palliative intendance
- anxiety disorders
- qualitative research
- mental health
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- leukaemia
- adult palliative care
- paediatric palliative care
- feet disorders
- qualitative research
- mental wellness
Strengths and limitations of this written report
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This report will examine the longitudinal form and predictors of traumatic stress symptoms of family caregivers of patients diagnosed with acute leukaemia at key timepoints in their illness and handling trajectory.
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Qualitative interviews analysed using a grounded theory approach will preserve the complexity and context of the caregiver feel and volition integrate with the quantitative data to deepen our understanding of their traumatic stress symptoms.
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The inclusion of a diverse group of family unit caregivers with variance in characteristics such every bit historic period, sex activity, gender, race, ethnicity, attachment style, relationship to patient and blazon of leukaemia provides an opportunity to empathize the bear on of caregiver factors on traumatic stress symptoms.
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The generalisability of our findings may exist limited by caregiver enrolment from cancer intendance centres in a single metropolitan area and the potential for choice bias.
Introduction
Acute leukaemia (AL) is a life-threatening haematological malignancy characterised past rapid onset, the requirement for firsthand hospitalisation to initiate care and intensive and prolonged medical treatment. The chief types of AL are astute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). Both occur in patients of all ages, only the epidemiology, illness features and outcomes vary with age and affliction type. Handling of AL is associated with the run a risk of serious and potentially fatal side effects including bleeding, infection, mucositis, nausea and airsickness, hurting and multiple other drug-specific side furnishings.one–three There is now robust evidence showing that the diagnosis of AL in patients from infants to older adults is a singularly stressful event, followed by a period of intense and hard life choices and experiences.4–ix Those who are cured of AL may still endure long-term treatment sequelae including neurocognitive deficits, infertility, endocrine, musculoskeletal and cardiac impairments, and take a chance of secondary cancers.6 x–fourteen
The impact of AL on family caregivers
The diagnosis of AL and its treatment impose a substantial burden on family caregivers (FCs), who may be partners, adult children or parents.vii–9 FCs of patients with cancer are increasingly expected to presume lead roles in circuitous clinical tasks, such as coordination of care, symptom management, medication administration and direct patient care, while maintaining other ongoing responsibilities, such equally employment and care for other dependents.fifteen–23 These multiple roles, coupled with fiscal strain due to the cost of non-reimbursed medical care, travel, other family unit caregiving and home responsibilities, and the loss of employment income, are major sources of distress for FCs.16 24 25 This burden of caring,24 which falls disproportionately on women,26 and the abiding threat that a partner, parent or kid volition suffer or die, constitute substantial threats to the mental and physical health of FCs.27–29
Traumatic stress symptoms
The immediate psychological response to the diagnosis of a life-threatening cancer of both patients and FCs is often traumatic stress (TS) symptoms.4 5 28 30 These symptoms include hyperarousal (eg, hypervigilance, decreased concentration, heightened startle response, insomnia, irritability), intrusive thoughts (eg, nightmares, flashbacks, altered sense of reality), emotional detachment or numbing and depression.31 32 Symptoms of TS occurring inside ane month of the traumatic event may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for acute stress disorder (ASD) and those that persist for longer than a month may meet diagnostic criteria for post-traumatic stress disorder (PTSD).31 Risk factors for ASD and PTSD following a traumatic event include younger age, female sex, feminine gender role and straight or vicarious exposure to traumatic events, including in starting time responders to trauma victims.33–35 Gender is not only a run a risk factor for PTSD in its ain right merely is likewise a proxy for multiple interacting social, economic and political influences on distress.36 As a whole, TS disorders are highly disturbing to those affected and are associated with a subsequent x-fold increase in the risk of completed suicide37 and an increased run a risk of cardiovascular, metabolic and musculoskeletal disorders38 and all-cause bloodshed.39
The social context of TS symptoms
The social environment in which individuals exposed to trauma are situated has been shown to directly touch on the severity and nature of TS symptoms.36 In that regard, the changed relationship between symptoms of PTSD and social support, including that received from healthcare professionals (HCPs), is one of the most consistent relationships observed in trauma enquiry.40–42 Internalised representations of back up and the capacity to brand apply of it, reflected in the construct of zipper security,43 take also been shown to protect from the development of PTSD post-obit exposure to trauma.44 Measured on dimensions of attachment anxiety and attachment avoidance,45 46 attachment security has been shown to play a critical role in the management of terror, specifically that related to death feet.47
TS symptoms in FCs
Clinically significant TS symptoms are common in FCs of patients with metastatic cancer, with similar rates in partners and parents of patients.28 48 Risk factors that have been identified for the development of TS symptoms in FCs of patients include: (i) FC variables such every bit female person sex,49 identification with traditionally feminine gender roles,28 50 younger historic period,27 less social support and less zipper security,51 lower family income29 and higher perceived brunt of caregiving tasks52 53; (ii) patient variables such equally younger age54 and greater disease severity55; and (iii) the nature of the caregiver–patient relationship,56 with close familial relationships existence associated with greater TS.57 58
Research has demonstrated the psychological impact of metastatic cancer on patients59 60 and their FCs.58 Several studies have highlighted the psychological impact of haematological malignancies on patients.4 5 61 However, there has been picayune research attention to the psychological consequences of haematological malignancies on FCs, and systematic approaches to forestall and alleviate distress in this loftier-run a risk population have not been developed. The acute onset of AL, the intensive and prolonged treatment, the substantial burden of caregiving and the uncertainty regarding clinical outcomes advise that TS symptoms may be common in FCs. Nevertheless, the prevalence, severity, and predictors of TS over time, and the experience of FCs of patients with AL across the life class have non been determined.
Study objectives
The objectives of the present written report are to make up one's mind in FCs of patients with AL:
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The prevalence, severity, longitudinal course and predictors of TS symptoms over the first year post-obit a new diagnosis of AL.
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The FC feel of TS, including the impact of AL on their lives and that of their families, the nature of their distress, their relationship with HCPs, and their perceived resource and met and unmet support needs.
The findings from this study will provide essential information to inform research, clinical do and health policy regarding the comprehensive and family-centred treatment of AL.
Methods and analysis
Patient and public interest
This study will be conducted with the early and ongoing date of FCs and other stakeholders. Specifically, our FC collaborators and HCP collaborators have informed the construction of this study, including the mixed methods approach and relevant sampling timepoints, will be closely involved in the estimation and dissemination of the information, and volition lead in advancement efforts to back up policy alter related to the care of FCs. The patient and family unit informational councils at our written report sites will besides exist engaged to back up study conduct from implementation to dissemination.
Study blueprint and setting
This is a prospective, observational study using mixed quantitative and qualitative methodology. FCs will be recruited from the Princess Margaret Cancer Centre, part of the University Health Network, and the Infirmary for Sick Children, both in Toronto, Canada.
Eligibility criteria
FCs will be: (i) the self-identified chief or co-principal caregiver (ie, divers in this study every bit the person bold at to the lowest degree 40% of patient intendance activities) of a paediatric or adult patient newly diagnosed with primary AL (AML or ALL) inside 3 months of admission to either of our report sites; (ii)≥xviii years old; and (three) fluent in English.
Ineligibility criteria
FCs of patients with acute promyelocytic leukaemia or who practice not receive induction chemotherapy with curative intent will exist ineligible.
Data collection
FC recruitment will occur over 36 months and is expected to be completed in 2024. Following informed consent, participating FCs will complete a demographics questionnaire and the affliction-related characteristics of the associated patient will be abstracted from the patient's medical chart (table 1). FCs will so complete a baseline outcome questionnaire bundle on REDCap (ie, a secure online browser-based awarding for building and managing online surveys and inquiry databases), and follow-up online outcome questionnaire packages at ane, 3, six, 9 and 12 months after the patient's access to the hospital for a new diagnosis of AL (table one). Questionnaire package completion time is expected to be xx–xxx min at each assessment point. A subgroup of FCs will be invited to participate in sound- and/or video-recorded, semi-structured, qualitative interviews at 3, 6 and 12 months. Interviewees may participate in interviews at more than than 1 sampling timepoint. Sampling for interviews will be purposeful in an try to achieve maximum variation in FC characteristics including historic period, sexual practice, gender, gender function, FC–patient relationship, scores on quantitative measures, race, ethnicity and patient's AL type. The interviews will be conducted by a trained interviewer and volition focus on the FC experience of caring for someone with AL, the affect of caring on the lives of FCs and that of their families, FC met and unmet support needs, and the FC feel with the patient'south handling and HCPs (box 1). Interviews are expected to last betwixt 30–60 min.
View this table:
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Table ane
Timeline of study activities
Box one
Example questions from the semi-structured qualitative interview guide
Bear upon of the disease
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Tin yous describe what it was like for you when you first heard about (patient's) diagnosis of leukaemia?
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How, if at all, take things changed for you since (patient's) diagnosis of leukaemia?
Experience of support
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How supported have you felt?
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What types of back up have you received?
Experience of care
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What is your experience with the care (patient) has received from the hospital?
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Can you describe your human relationship with the medical team?
Outcome measures
Primary issue
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TS symptoms, will be measured with the 30-item Stanford Acute Stress Reaction Questionnaire (SASRQ-II)62 63 updated to be DSM-five-concordant31 for ASD symptoms. This scale is one of the most widely used scales for measuring TS symptoms and has demonstrated test–retest reliability,62,63 and predictive, construct, discriminant and convergent validity beyond diverse samples.62–66 The English DSM-5-concordant version of the SASRQ (ie, SASRQ-2) has not yet been validated. Therefore, the 20-item PTSD Checklist for DSM-five (PCL-5) volition as well be administered.67 The PCL-5 is widely used to assess TS symptoms and the revised DSM-v version has demonstrated skillful psychometric properties.68–lxx
Predictors
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Attachment security, will be measured with the modified and brief Experiences in Close Relationships (ECR-M16) scale.46 The ECR-M16 is a widely used, reliable and valid sixteen-item measure of zipper security with subscales assessing anxious and avoidant attachment.
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Depressive symptoms , will be measured with the Patient Wellness Questionaire-9 (PHQ-9).71 The PHQ-9 is a reliable and valid 9-item measure routinely administered to screen for depressive symptoms in cancer. Two additional items assessing suicidal intent and interference with life have been added.72 73
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Caregiver burden, will be measured with the Caregiver Reaction Assessment (CRA) scale.74 The CRA is a reliable and valid 24-item scale assessing positive and negative reactions to five domains of caregiver burden: disrupted schedule, financial problems, lack of family support, health bug and the affect on self-esteem.
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Perceived social support , volition be measured with the ENRICHD Social Back up Musical instrument (ESSI).75 The ESSI is a 7-detail scale assessing the perceived availability of social support. This mensurate has been used in AL and has shown good reliability and validity.76 77
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FC satisfaction with care , volition exist measured with the Family Satisfaction with Stop-of-Life Intendance (FAMCARE) scale.78 The FAMCARE is a reliable and valid 20-particular scale measuring satisfaction with the behaviour of HCPs towards FCs and the patients they care for diagnosed with advanced cancer.
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Gender part , will be measured (at baseline only) with the Traditional Masculinity-Femininity (TMF) calibration.79 The TMF is a 6-item scale that assesses the degree to which people view their interests, selves, behaviour and other aspects as masculine or feminine. It has been validated in multiple cultural and age-group contexts.eighty
Sample size
Quantitative
Our sample size calculation for determining TS prevalence in FCs is based on the following established formula81 to estimate sample sizes for descriptive studies:
where n = sample size, Z = Z statistic for confidence level, P = expected prevalence and d = level of precision. Based on previous prevalence estimates of TS in our adult sample of patients with AL (ie, fourteen% meeting criteria for ASD every bit measured with the SASRQ)4 and the 11.8% PTSD prevalence in FCs of solid tumour patients,48 we have conservatively gear up our expected prevalence to .xiv, Z to 1.96, and d to .05 (an appropriate precision for the expected prevalence81). The necessary sample size is 185. Our predictable compunction rate is xv% based on previous longitudinal enquiry at our written report sites.5 82 To recoup for compunction, the enrolment of at least 213 FCs is required to achieve our objective of determining TS prevalence in FCs. Based on expected new AL cases at both sites, we can feasibly recruit 223 FCs inside our 36-month recruitment period and volition therefore aim for this target.
Nosotros will also utilize multi-level modelling (MLM) as a non-machine learning (ML) benchmark model to decide potential TS predictors and have, therefore, calculated a power estimate for N=185 using GLIMMPSE V.3 online software,83 84 which performs ability and sample size calculations for multilevel designs. We derived power estimates for the post-obit parameters, with the SASRQ total score as the event: a pattern with eight groups (ie, to reflect crossing of caregiver gender (categorical predictor; female/male), patient historic period (continuous predictor; younger/older), and attachment security (continuous predictor; lower/higher) every bit the possible master three MLM predictors of interest) and half-dozen timepoints; decreasing intercorrelation beyond repeated measures, from .sixty to .52; and mean and standard deviaition (SD) scaling factors of 1 and 1.5, to account for dubiousness about observed means and SDs. Power estimates were calculated for each two-fashion predictor x time interaction equally the chief hypothesis tested. Entered mean and SD estimates for the SASRQ were based on estimates from a recent phase Ii longitudinal clinical trial of a psychological-palliative care intervention for patients with AL.one The ranges of computed power estimates for a calculated sample size of 185 are: for Caregiver Gender × Fourth dimension, .34–.89 (ability judge for means and SDs without scaling=0.51); for Attachment Security × Time, .81–1.00 (power estimate without scaling=0.95); and for Patient Age × Time, .85–1.00 (power without scaling=0.97).
Qualitative
Our interview sample size will exist determined past data saturation. Based on our previous qualitative work and our heterogeneous sample, we estimate that a purposeful subgroup of thirty FCs will participate in interviews at the 3, half dozen and 12-calendar month timepoints.85–88
Analysis
Quantitative
All quantitative analyses will be conducted with R software and alpha will be gear up to .05.89 Descriptive statistics will be used for FC sociodemographic and patient medical characteristics. We volition descriptively characterise the prevalence and severity (with variability) of TS symptoms.
A broad range of candidate predictors of TS symptoms have been identified.33 However, the heterogeneity of risk factors, the clinical appearance and aetiology of TS hampers the analysis of take a chance factors using traditional regression models.90 The high dimensionality and likely multicollinearity amongst predictors and interaction of predictors pose challenges for statistical models and require the application of advanced computational approaches.91 Studies using advanced ML have been developed to examine predictors of psychiatric risk such as PTSD run a risk and to facilitate the implementation of precision psychiatry into clinical practice.92–97 We will use a supervised ML arroyo that is based on well-established methodologies in clinical prediction modelling including data pre-processing, such as handling of missing values, guarding against 'overfitting', and rigorous model evaluation in terms of established metrics for bigotry and calibration.98–103 Confidence intervals for all indicate estimates will exist calculated to communicate uncertainty of the model. Moreover, to assess the generalisation ability of the model on data non used to develop the model, nosotros will division the data to perform a held-out validation test.103 104
Nosotros will use latent growth mixture modelling (LGMM) to identify heterogeneous longitudinal trajectories of TS response.105 Individuals will be assigned to trajectories based on their most probable class membership. The best-fitting model will exist selected based on the Information Criteria (Akaike Information Criteria, Bayesian Data Criteria (BIC), and Sample Size Adjusted BIC), along with fit statistics (such as the Bootstrap Log Likelihood Test), likewise equally parsimony and interpretability consistent with recommendations from the literature.106 107 We volition test various predictive models for robustness in predicting LGMM trajectories, including random woods and support vector machines. As the final model, we will select the simplest model within i standard error of the all-time model to allow for a more parsimonious model. We will criterion our predictive model with computational simpler models (including MLM). Predictors included in our models will exist FC age, sex, gender, gender office, family income, baseline attachment security, perceived social support, caregiver burden, and satisfaction with provided care, relationship to patient, and patient age and treatment response. We will utilize Explainable Motorcar Learning using SHAP (SHapley Additive exPlanation)108 to identify those features that are mainly responsible for driving the individual event prediction. Information technology is an additive characteristic attribution method that uses kernel functions and a well-established method to interpret ML models.108 We volition besides use SHAP dependence plots to examine potential interactions among the three most important predictors in the ML model.
We will confirm our predictor-related findings using MLM, which permits cases with missing data to exist included in longitudinal modelling. In this case, we will use the three nigh important predictors to prevent 'overfitting', identified in the ML approach to exam for direct linear relationships. The chief effects of each of these predictors, their individual interactions with Time, and their random effects will be examined. Sociodemographic and medical covariates, including disease type (ALL vs AML) and depressive symptoms, will be entered to control for their effects.
Qualitative
All interview audio-recordings will exist transcribed verbatim by a trained member of the squad, verified for accuracy, de-identified to protect privacy and imported, along with field notes, into NVivo software109 for data management and assay. Consistent with a abiding comparative method, information analyses will begin once the first interview has been transcribed, allowing data from early interviews to inform later interviews.110 Data will exist independently coded in duplicate using a line-by-line approach by trained qualitative analysts using a coding tree adult using the team's expertise and the TS scientific literature. Using content analysis, codes will be grouped into categories based on betwixt-code relationships and categories will and so be grouped into themes according to the predictors and longitudinal grade of TS symptoms.111 112 Categories and themes will then exist compared beyond FC traits to sympathize similarities and differences in experiences depending on these characteristics. Quantitative data will be integrated into the assay process to illustrate or analyze qualitative results related to the FC experience using a mixed methods matrix arroyo.113 Any discrepancies in opinion regarding coding will exist resolved using mediation with our study team at regularly occuring information assay review coming together. An audit trail consisting of a detailed chronology of information collection and analytical decisions will exist kept to enhance validity.114
Ethics and dissemination
Ethics
The study received provincial approval from the Ontario Cancer Research Ethics Board (CTO Project ID: 2104) on 22 July 2021, and heart approval for both sites in October 2021. Institutional authorisation was provided past both sites in November 2021.
Broadcasting
Nosotros have designed an evidence-based dissemination strategy aimed at increasing awareness and knowledge of the psychological risks to FCs of patients with AL,115 besides as FC-level and patient-level factors associated with these risks, to inform scientific investigation in the field and change betoken-of-care practice. Our dissemination strategy will include the presentation of results at major psychosocial and medical oncology conferences, publications in leading medical or oncology journals, and postings on key websites such equally the Global Found of Psychosocial, Palliative and End-of-Life Care (GIPPEC; www.gippec.org) based at the Princess Margaret Cancer Centre and the University of Toronto, affiliated hospitals and universities, and via our collaborative partnerships with local, national, and international oncology groups. The following materials will also be developed and disseminated: (i) a one-folio brochure for oncology HCPs at developed and paediatric centres; (2) a 3-infinitesimal YouTube video; (iii) media releases; and (4) fact sheets to support patients and FCs beyond Canada to abet for policy alter, if warranted. Furthermore, specific implications pertaining to FC subgroups (eg, those differing across sexual activity, gender, ethnicity, caregiver role, etc.) will be highlighted in manuscripts and other knowledge translation efforts to bolster impacts across the variety of FCs.
Conclusion
The present mixed methods, longitudinal study of the psychological bear on on FCs of individuals diagnosed with AL across the life cycle is the first of its kind and volition provide a comprehensive agreement of the FC lived experience and subjective distress, besides as associated supportive intendance needs. The quantitative and qualitative results volition inform the evolution of a tailored psychosocial intervention to prevent or alleviate TS in this high-chance population and take the potential to be applied to other life-threatening medical conditions.
Ethics statements
Patient consent for publication
Acknowledgments
The authors thank research coordinators Elham Hashemi at the Infirmary for Sick Children and Kyle Fitzgibbon, Ally Yu, Rebecca Wong, and Angela Mathews at the Princess Margaret Cancer Centre, for their continued back up of this project.
38/9 As A Mixed Number,
Source: https://bmjopen.bmj.com/content/12/11/e065422
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