The Melanoma Care Study: Protocol of a randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease

Background: Despite a good prognosis for most melanoma survivors, many experience substantial fear of new or recurrent melanoma, worry and anxiety about the future, and unmet healthcare needs. In this protocol, we outline the design and methods of the Melanoma Care Study for melanoma survivors at high risk of developing new primary disease. The objective of this study is to evaluate the efficacy and cost-effectiveness of a psycho-educational intervention for improving psychological and behavioural adjustment to melanoma risk. Design: The study design is a two-arm randomised controlled trial comparing a psycho-educational intervention to usual care. Methods: The intervention is comprised of a newly-developed psycho-educational booklet and three telephone sessions delivered by a trained psychologist. A total of 154 melanoma survivors at high risk of developing new primary disease who are attending one of three melanoma high risk clinics in New South Wales, Australia, will be recruited. Participants will be assessed at baseline (6 weeks before their high risk clinic dermatological appointment), and then 4 weeks and 6 months after their appointment. If effectiveness of the intervention is demonstrated at 6 months, an additional assessment at 12 months is planned. The primary outcome is fear of new or recurrent melanoma, as assessed by the Fear of Cancer Recurrence Inventory (FCRI). Secondary outcomes include anxiety, depression, unmet supportive care needs, satisfaction with clinical care, knowledge, behavioural adjustment to melanoma risk, quality of life, and cost-effectiveness of the intervention from a health system perspective. Following the intention-to-treat principle, linear mixed models will be used to analyse the data to account for repeated measures. A process evaluation will also be carried out to inform and facilitate potential translation and implementation into clinical practice. Discussion: This study will provide high quality evidence on the efficacy and cost-effectiveness of a psycho-educational intervention aimed at improving psychological and behavioural adjustment amongst melanoma survivors at high risk of new primary disease

Screening for distress and needs: Findings from a multinational validation of the Adolescent and Young Adult Psycho-Oncology Screening Tool with newly diagnosed patientsInternational AYA Cancer Distress Screening Group

Objective: Adolescents and young adults (AYAs) diagnosed with cancer commonly experience elevated psychological distress and need appropriate detection and management of the psychosocial impact of their illness and treatment. This paper describes the multinational validation of the Distress Thermometer (DT) for AYAs recently diagnosed with cancer and the relationship between distress and patient concerns on the AYA-Needs Assessment (AYA-NA). Methods: AYA patients (N = 288; 15–29 years, Mage = 21.5 years, SDage = 3.8) from Australia (n = 111), Canada (n = 67), the UK (n = 85) and the USA (n = 25) completed the DT, AYA-NA, Hospital Anxiety Depression Scale (HADS) and demographic measures within 3 months of diagnosis. Using the HADS as a criterion, receiver operating characteristics analysis was used to determine the optimal cut-off score and meet the acceptable level of 0.70 for sensitivity and specificity. Correlations between the DT and HADS scores, prevalence of distress and AYA-NA scores were reported. Results: The DT correlated strongly with the HADS-Total, providing construct validity evidence (r = 0.65, p < 0.001). A score of 5 resulted in the best clinical screening cut-off on the DT (sensitivity = 82%, specificity = 75%, Youden Index = 0.57). Forty-two percent of AYAs scored at or above 5. ‘Loss of meaning or purpose’ was the AYA-NA item most likely to differentiate distressed AYAs. Conclusions: The DT is a valid distress screening instrument for AYAs with cancer. The AYA-POST (DT and AYA-NA) provides clinicians with a critical tool to assess the psychosocial well-being of this group, allowing for the provision of personalised support and care responsive to individuals' specific needs and concerns

Some recommendations for developing multidimensional computerized adaptive tests for patient-reported outcomes

PURPOSE: Multidimensional item response theory and computerized adaptive testing (CAT) are increasingly used in mental health, quality of life (QoL), and patient-reported outcome measurement. Although multidimensional assessment techniques hold promises, they are more challenging in their application than unidimensional ones. The authors comment on minimal standards when developing multidimensional CATs. METHODS: Prompted by pioneering papers published in QLR, the authors reflect on existing guidance and discussions from different psychometric communities, including guidelines developed for unidimensional CATs in the PROMIS project. RESULTS: The commentary focuses on two key topics: (1) the design, evaluation, and calibration of multidimensional item banks and (2) how to study the efficiency and precision of a multidimensional item bank. The authors suggest that the development of a carefully designed and calibrated item bank encompasses a construction phase and a psychometric phase. With respect to efficiency and precision, item banks should be large enough to provide adequate precision over the full range of the latent constructs. Therefore CAT performance should be studied as a function of the latent constructs and with reference to relevant benchmarks. Solutions are also suggested for simulation studies using real data, which often result in too optimistic evaluations of an item bank's efficiency and precision. DISCUSSION: Multidimensional CAT applications are promising but complex statistical assessment tools which necessitate detailed theoretical frameworks and methodological scrutiny when testing their appropriateness for practical applications. The authors advise researchers to evaluate item banks with a broad set of methods, describe their choices in detail, and substantiate their approach for validation

Symptom clusters in patients with advanced cancer: A systematic review of observational studies

© 2014 American Academy of Hospice and Palliative Medicine. Context. Advanced cancer patients typically experience multiple symptoms, which may influence patient outcomes synergistically. The composition of these symptom clusters (SCs) differs depending on various clinical variables and the timing and method of their assessment. Objectives. The objective of this systematic review was to examine the composition, longitudinal stability, and consistency across methodologies of common SCs, as well as their common predictors and outcomes. Methods. A search of MEDLINE, CINAHL, Embase, Web of Science, and PsycINFO was conducted using variants of symptom clusters, cancer, and palliative care. Results. Thirty-three articles were identified and reviewed. Many SCs were identified, with four common groupings being anxiety-depression, nausea-vomiting, nausea-appetite loss, and fatigue-dyspnea-drowsiness-pain. SCs in most cases were not stable longitudinally. The various statistical methods used (most commonly principal component analysis, exploratory factor analysis, and hierarchical cluster analysis) tended to reveal different SCs. Different measurement tools were used in different studies, each containing a different array of symptoms. The predictors and outcomes of SCs were also inconsistent across studies. No studies of patient experiences of SCs were identified. Conclusion. Although the articles reviewed revealed four groups of symptoms that tended to cluster, there is limited consistency in the way in which SCs and variables associated with them are identified. This is largely due to a lack of agreement about a robust, clinically relevant definition of SCs. Future research should focus on patients' subjective experience of SCs to inform a clinically relevant definition of SCs and how they are managed over time

Psychometric properties of the Fear of Cancer Recurrence Inventory: an item response theory approach

Objective: Classical psychometric methods have been used to demonstrate the validity and reliability of the 42-item Fear of Cancer Recurrence Inventory (FCRI). Our aim was to expand on this evidence with information on the discriminative value of the individual items when administered to people with a personal history of melanoma, using an item response theory (IRT) approach. Methods: We used a two-parameter IRT model to examine all items of the FCRI, primarily regarding whether people with a personal history of melanoma use the response scale as expected (as indicated by item characteristic curves), and whether the items can discriminate between those low and high on the constructs assessed by the instrument. Results: The sample was comprised of 286 adults with a personal history of melanoma (58% male, mean age: 59.1 years). The established factor structure of the FCRI was generally confirmed. IRT highlighted several items with problematic item characteristic curves, including most items in the Reassurance and Coping Strategies domains. Several other items exhibited poor discrimination. Conclusions: Based on this IRT analysis, we outline suggestions for refinement of the FCRI and potential development of a short-form, that could reduce respondent burden. Generalisability of these findings beyond melanoma warrants further examination

Validation of an Australian parenting health literacy skills instrument: The parenting plus skills index.

OBJECTIVE: Existing instruments for assessing health literacy skills in parents have limited scope to inform the design and evaluation of health literacy interventions. In this study we aimed to develop and validate a new performance-based measure of health literacy for Australian parents, the Parenting Plus Skills Index (PPSI). The instrument aimed to assess functional, communicative and critical health literacy skills. METHODS: The PPSI was developed in three phases: 1) Modified Delphi Expert Panel to provide feedback on 34 initial items; 2) Evaluation of psychometric properties of each item using a multidimensional item response theory model in a sample of Australian adults of parenting age (20-44 years) (N = 500); 3) Assessment of subset of items in an independent sample (N = 500). RESULTS: Following the three phases, 13 items were included in the final instrument. Participants scored on average 8.9/13 (69 %). The instrument demonstrated acceptable reliability (r = 0.70) and was significantly correlated with other performance-based health literacy instruments. CONCLUSIONS: The PPSI is a validated 13-item performance-based instrument that assesses health literacy skills for parents in an Australian setting. PRACTICE IMPLICATIONS: The PPSI fills an important gap in available health literacy instruments that may be useful for facilitating development and evaluation of health literacy interventions

Health-Related Quality of Life in Children, Adolescents, and Adults With a Fontan Circulation: A Meta-Analysis.

Background People with a Fontan circulation experience a range of physical, psychosocial and neurodevelopmental challenges alongside, or caused by, their cardiac condition, with significant consequences for health-related quality of life (HRQOL). We meta-analyzed HRQOL outcomes reported by people with a Fontan circulation or their proxies and evaluated predictors of poorer HRQOL. Methods and Results Six electronic databases were searched for peer-reviewed, English-language articles published before March 2019. Standardized mean differences (SMD) were calculated using fixed and random-effects models. Fifty articles reporting on 29 unique studies capturing HRQOL outcomes for 2793 people with a Fontan circulation and 1437 parent-proxies were analyzed. HRQOL was lower in individuals with a Fontan circulation compared with healthy referents or normative samples (SMD, -0.92; 95% CI, -1.36 to -0.48; P<0.001). Lower scores were reported across all HRQOL domains, with the largest differences found for physical (SMD, -0.90; 95% CI, -1.13 to -0.67; P<0.001) and school/work functioning (SMD, -0.71; 95% CI, -0.90 to -0.52; P<0.001). Meta-regression analyses found no significant predictors of self-reported physical functioning, but older age at Fontan operation was associated with poorer emotional functioning (β=-0.124; P=0.004), and diagnosis of hypoplastic left heart was associated with poorer social functioning (β=-0.007; P=0.048). Sensitivity analyses showed use of the PedsQL Core Module was associated with lower HRQOL scores compared with the Short-Form Health Survey-36. Conclusions HRQOL outcomes for people with a Fontan circulation are lower than the general population. Optimal care acknowledges the lifelong impact of the Fontan circulation on HRQOL and offers targeted strategies to improve outcomes for this growing population

Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review

Objective Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring ongoing treatment and endoscopic examinations that are frequent and can be life-long. To ensure the comprehensive assessment of the benefits and harms of treatments for NMIBC, the impact on important and relevant patient-reported outcomes (PROs) should be determined. We systematically reviewed the NMIBC PRO literature to determine the suitability of available PRO measures (PROMs) for use in evaluating patient outcomes in NMIBC research. Methods We searched six electronic databases, reference lists, and key authors. Two reviewers independently applied inclusion and quality criteria and extracted findings. PROM domains, item content, and content coverage and relevance were determined for identified PROMs. Content validity was assessed against an empirically derived NMIBC-specific conceptual framework that includes 11 PRO domains and 19 sub-domains. Results Seventeen studies assessed PROs related to NMIBC and treatment impact. From these studies, 11 PROMs were identified, including three generic, three cancer-specific, and five symptom-specific. None of the PROMs cover all PRO domains important in NMIBC as assessed against our conceptual framework. The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model, but failed to represent six outcomes important to NMIBC patients. Conclusions Currently, some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models. This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients. Careful consideration of PROM item content is required when selecting outcome measures for use in future NMIBC clinical trials to ensure that appropriate measures are used to assess outcomes that matter to patients

Protocol for a within-trial economic evaluation of a psychoeducational intervention tailored to people at high risk of developing a second or subsequent melanoma

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. METHOD AND ANALYSIS: The economic evaluation is a within-trial analysis to evaluate the incremental costs and health outcomes of a psychoeducational intervention compared to usual care from the perspective of the Australian healthcare system. Cost-effectiveness and cost-utility analyses will be conducted, providing estimates of the cost to reduce fear of melanoma recurrence and the cost per quality-adjusted life-year (QALY) gained. Fear of melanoma recurrence will be measured using the Fear of Cancer Recurrence Inventory and preference-based quality of life measured using the Assessment of Quality of Life-8 Dimensions (AQoL-8D) instrument. The AQoL-8D will provide utilities for estimation of QALYs in the cost-utility analysis. Unit costs of health services and medicines will be taken from the Medicare Benefits Schedule and the Pharmaceutical Benefits Scheme national databases. Health outcomes, and health service and medication use will be collected at baseline, 6 and 12 months follow-up. The within-trial analysis will be conducted at 12 months, consistent with the end point of the trial.ETHICS AND DISSEMINATION: Approval to conduct the study was granted by the Sydney Local Health District (RPAH zone) Ethics Review Committee (X13-0065 and HREC/13/RPAH/86), the Department of Health and Ageing Human Research Ethics Committee (21/2013), the University of Sydney Human Research Ethics Committee (2013/595), and the Australian Institute of Health and Welfare Ethics Committee (EO 2013/4/58).TRIAL REGISTRATION NUMBER: ACTRN12613000304730; Pre-results.INTRODUCTION: Psychological support programmes are not currently funded for people with a history of melanoma. A major barrier to the implementation of effective psychological interventions in routine clinical care is a lack of cost-effectiveness data. This paper describes the planned economic evaluation alongside a randomised controlled trial of a psychoeducational intervention for people with a history of melanoma who are at high risk of developing new primary disease

Encouraging early discussion of life expectancy and end-of-life care: A randomised controlled trial of a nurse-led communication support program for patients and caregivers

© 2016 Elsevier Ltd Background Patients are often not given the information needed to understand their prognosis and make informed treatment choices, with many consequently experiencing less than optimal care and quality-of-life at end-of-life. Objectives To evaluate the efficacy of a nurse-facilitated communication support program for patients with advanced, incurable cancer to assist them in discussing prognosis and end-of-life care. Design A parallel-group randomised controlled trial design was used. Settings This trial was conducted at six cancer treatment centres affiliated with major hospitals in Sydney, Australia. Participants 110 patients with advanced, incurable cancer participated. Methods The communication support program included guided exploration of a question prompt list, communication challenges, patient values and concerns and the value of discussing end-of-life care early, with oncologists cued to endorse question-asking and question prompt list use. Patients were randomised after baseline measure completion, a regular oncology consultation was audio-recorded and a follow-up questionnaire was completed one month later. Communication, health-related quality-of-life and satisfaction measures and a manualised consultation-coding scheme were used. Descriptive, Mixed Modelling and Generalised Linear Mixed Modelling analyses were conducted using SPSS version 22. Results Communication support program recipients gave significantly more cues for discussion of prognosis, end-of-life care, future care options and general issues not targeted by the intervention during recorded consultations, but did not ask more questions about these issues or overall. Oncologists’ question prompt list and question asking endorsement was inconsistent. Communication support program recipients’ self-efficacy in knowing what questions to ask their doctor significantly improved at follow-up while control arm patients’ self-efficacy declined. The communication support program did not impact patients’ health-related quality-of-life or the likelihood that their health information or shared decision-making preferences would be met. Satisfaction with the communication support program was high. Conclusions Given the importance of clarifying prognostic expectations and end-of-life care wishes in the advanced cancer context, the communication support program appears to be an effective and well-received solution to encourage early information seeking related to these issues though, its long-term impact remains unclear. The manualised nature of the intervention, designed with existing clinical staff in mind, may make it suited for implementation in a clinical setting, though additional work is needed to identify why question asking was unaffected and establish its impact later in the illness trajectory