Patient-reported outcomes in melanoma survivors at 1, 3 and 5 years post-diagnosis: a population-based cross-sectional study.

PURPOSE: There is a lack of population-based data describing patient reported outcomes (PROs) in melanoma survivors which could guide the development of interventions and resources. This study assessed overall quality of life (QoL), self-reported symptoms and unmet information needs in melanoma survivors 1, 3 or 5 years post-diagnosis. METHODS: A cross-sectional postal survey was conducted in Victoria, Australia, with eligible melanoma survivors identified from a population-based cancer registry. Patient-reported outcome measures included the EuroQoL 5-Dimension 5-Level (EQ-5D-5L), and self-reported symptoms, difficulties and information needs. Associations between demographic, disease and care-related factors and QoL were also assessed. RESULTS: A total of 476 melanoma survivors participated in the study (response rate 46.5%). Anxiety and depressive symptoms were more prevalent in survivors compared to the general population (30.7% vs 21.6%; p < 0.01). Fear of cancer recurrence (48.3%) and fear of cancer spreading (37.8%) were the most commonly reported symptom items, and approximately one in five melanoma survivors had unmet information needs related to psychological aspects of living with melanoma. Recurrent melanoma, living in a nursing home, chronic comorbidities, and melanoma diagnosed at > 2 mm thickness were associated with lower QoL. CONCLUSION: A large proportion of melanoma survivors reported ongoing quality of life deficits, fear of cancer recurrence, as well as unmet information needs up to 5 years after diagnosis. Patients may benefit from tailored informational resources and interventions that address the psychological aspects of living with and beyond melanoma.

Development of the Melanoma Concerns Questionnaire (MCQ-28); refinement of the EORTC QLQ-MEL38 module.

OBJECTIVE: Few patient-reported outcome measures (PROMs) have been developed that adequately measure the patient-experience following diagnosis and treatment of melanoma. Building on previous research, which developed the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Module (QLQ-MEL38), the aim of this study was to further test the hypothesised domain structure and psychometric properties of the phase 3 module, in a new larger sample of melanoma patients. METHODS: Melanoma patients (n = 270) were recruited from four countries (Australia, England, Serbia, and Spain). Patients completed the EORTC core questionnaire (QLQ-C30), the QLQ-MEL38, and a sociodemographic survey. Using this new larger dataset, comparisons were made with the hypothesised domain structure of the EORTC phase 3 module using principal component analysis. Items which formed subscales in a revised domain structure were then tested for goodness of fit (GoF) to the Rasch model. RESULTS: The original hypothesised and final domain structures were similar but not identical. Twenty-four items (83%) loaded onto the same distinct subscales previously generated by phase 3, and item-by-item comparison of the two pattern matrices indicated an extremely close match. Ten items were removed from the QLQ-MEL38 phase 3 module, and rescoring of some items was required. Four subscales, together with five individual items, comprised the final instrument. CONCLUSION: The newly developed measure (named the Melanoma Concerns Questionnaire; MCQ-28) was found to tap into several important psychosocial domains of concern to melanoma patients, particularly those being managed in "usual" clinic settings.

Associations between sex, age and spiritual well-being scores on the EORTC QLQ-SWB32 for patients receiving palliative care for cancer: A further analysis of data from an international validation study.

OBJECTIVE: The EORTC QOL Group has recently completed the cross-cultural development and validation of a standalone measure of spiritual well-being (SWB) for cancer patients receiving palliative care: the EORTC QLQ-SWB32. The measure includes four scales: Relationships with Others, Relationship with Self, Relationship with Someone or Something Greater, and Existential, plus a Global-SWB item. This paper reports on further research investigating relationships between sex, age and SWB for patients receiving palliative care for cancer-adjusting for other socio-demographic, clinical and function variables, including WHO performance status and EORTC QLQ-C15-PAL emotional and physical function scores. METHODS: Cross-sectional data from the validation study were used, and chi-square, independent t tests, Mann-Whitney U tests and multiple regression analyses applied. RESULTS: The study included 451 participants with advanced and incurable cancer, from 14 countries. Adjusted analyses found better scores for female participants than males on three of the four EORTC QLQ-SWB32 subscales; Relationship with others, Relationship with Someone or Something Greater and Existential plus Global-SWB. Older age was positively associated with better Relationship with Self. CONCLUSION: The findings from our participants suggest that it might be beneficial if healthcare providers seeking to address patients' spiritual needs pay particular attention to male patients, younger patients and those with poor emotional functioning.

Quality of Life Following Sentinel Node Biopsy for Primary Cutaneous Melanoma: Health Economic Implications.

BACKGROUND: Sentinel node biopsy (SNB) is commonly performed in contemporary melanoma management, however there is a paucity of long-term quality of life (QoL) estimates required for economic evaluation of this treatment. METHODS: A single-center, prospective, cross-sectional study of adults with American Joint Committee on Cancer stage I/II/IIIA melanoma of the limbs, trunk, or neck who had undergone wide excision and SNB, but not complete regional node dissection, was undertaken. Limb volume was measured using perometry, with lymphedema defined as a ≥10% volume increase in the ipsilateral limb compared with the contralateral limb. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire measured QoL. Associations between patient and treatment characteristics were assessed using linear regression. RESULTS: Among 694 patients (median time from SNB of 37 months), 14 (2%) had objectively measured lymphedema (i.e. an increase in limb volume of ≥10%). Of 687 stage I/II patients with complete QoL data, the mean weighted QoL was 0.745 (standard deviation 0.04) on a 0-1 scale (i.e. death to full health). In multivariable analysis, weighted QoL was 0.0004 higher for each year of increasing age (p = 0.001); 0.011 lower for females (p = 0.001), 0.018 lower following post-SNB limb trauma (p = 0.002); 0.252 lower for patients who perceived a large increase in limb size (p = 0.015); and 0.027 lower with self-reported difficulty in walking, running, or climbing stairs (p = 0.043). CONCLUSIONS: Our data suggest that very few patients treated at our institution had lymphedema in the long-term following SNB, with weighted QoL strongly associated with perceived rather than actual changes in limb size.

International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15.

PURPOSE: This international EORTC validation study (phase IV) is aimed at testing the psychometric properties of a quality of life (QoL) module related to oral health problems in cancer patients. METHODS: The phase III module comprised 17 items with four hypothesized multi-item scales and three single items. In phase IV, patients with mixed cancers, in different treatment phases from 10 countries completed the EORTC QLQ-C30, the QLQ-OH module, and a debriefing interview. The hypothesized structure was tested using combinations of classical test theory and item response theory, following EORTC guidelines. Test-retest assessments and responsiveness to change analysis (RCA) were performed after 2 weeks. RESULTS: Five hundred seventy-two patients (median age 60.3, 54 % females) were analyzed. Completion took <10 min for 84 %, 40 % expressed satisfaction that these issues were addressed. Analyses suggested a revision of the phase III hypothesized scale structure. Two items were deleted based on a high degree of item misfit, together with negative patient feedback. The remaining 15 items formed one eight-item scale named OH-QoL score, a two-item information scale, a two-item scale regarding dentures, and three single items (sticky saliva/mouth soreness/sensitivity to food/drink). Face and convergent validity and internal consistency were confirmed. Test-retest reliability (n = 60) was demonstrated as was RCA for patients undergoing chemotherapy (n = 117; p = 0.06). The resulting QLQ-OH15 discriminated between clinically distinct patient groups, e.g., low performance status vs. higher (p < 000.1), and head-and-neck cancer versus other cancers (p < 0.03). CONCLUSION: The EORTC module QLQ-OH15 is a short, well-accepted assessment tool focusing on oral problems and QoL to improve clinical management. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01724333.

Scalp cooling: a qualitative study to assess the perceptions and experiences of Australian patients with breast cancer.

PURPOSE: Chemotherapy-induced hair loss is a common and distressing side effect. Scalp cooling is increasingly being used to reduce this hair loss. The purpose of this study was to explore patients' perceptions and experience of scalp cooling. METHODS: Seventeen Australian women with a diagnosis of breast cancer participated in a focus group (n = 4) or a semi-structured interview (n = 3). Both scalp-cooled and non-scalp-cooled participant views were sought. Participant perceptions and experiences of scalp cooling were discussed as part of patients' overall chemotherapy experience and a thematic analysis conducted. RESULTS: Five themes emerged from the data: (1) scalp cooling in the context of treatment decision-making discussions, (2) hair loss expectations vs. experiences, (3) treatment-related expectations vs. experiences, (4) the promise of faster regrowth and (5) satisfaction with scalp cooling and future scalp cooling decision-making considerations. Information during treatment decision-making was the primary factor that influenced whether patient expectations were met. Faster regrowth was a motivator to continue treatment. Efficacy and tolerability of scalp cooling influenced future hypothetical treatment decision-making for both scalp-cooled and non-scalp-cooled participants. CONCLUSIONS: This study provides the first in-depth exploration of patient attitudes to scalp cooling. The results highlight a need for accurate information regarding efficacy and tolerability as well as hair care information to assist patients with their treatment decision-making.

Validity of a New Patient Engagement Measure: The Altarum Consumer Engagement (ACE) Measure.

OBJECTIVE: The objective of this study was to report on the validation of new scales [called the Altarum Consumer Engagement (ACE) Measure] that are indicative of an individual's engagement in health and healthcare decisions. The instrument was created to broaden the scope of how engagement is measured and understood, and to update the concept of engagement to include modern information sources, such as online health resources and ratings of providers and patient health. METHODS: Data were collected through an online survey with a US population of 2079 participants. A combination of Principal Component Analysis (PCA) and detailed Rasch analyses were conducted to identify specific subscales of engagement. Results were compared to another commonly used survey instrument, and outcomes were compared for construct validity. RESULTS: The PCA identified a four-factor structure composed of 21 items. The factors were named Commitment, Informed Choice, Navigation, and Ownership. Rasch analyses confirmed scale stability. Relevant outcomes were correlated in the expected direction, such as health status, lifestyle behaviors, medication adherence, and observed expected group differences. CONCLUSIONS: This study confirmed the validity of the new ACE Measure and its utility in screening for and finding group differences in activities related to patient engagement and health consumerism, such as using provider comparison tools and asking about medical costs.

Cross-cultural development of a quality-of-life measure for patients with melanoma: phase 3 testing of an EORTC Melanoma Module.

Melanoma is an increasingly common skin cancer worldwide. Recent treatment advances have provided patients and healthcare professionals (HCPs) with choices where quality of life (QoL) and toxicity are important considerations. A melanoma-specific QoL questionnaire is being developed in a cross-cultural setting using a four phase process developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. In phase 1, a literature search identified a list of pertinent QoL issues; this was shown to HCPs and patients in eight countries and rated for importance and relevance. Questions were constructed for the highest-rated issues (phase 2) and piloted in another patient sample (phase 3). Using EORTC Quality of Life Group criteria and sequential use of factor and Rasch analysis, scales were hypothesized for field testing (phase 4). Seven QoL domains (disease symptoms, treatment issues, financial issues, access/quality of information, satisfaction with care, psychosocial issues and support), comprising 73 QoL issues, were rated by 46 HCPs and 78 patients. Fifty-six issues were rephrased as questions and piloted with 132 patients. A 38-item questionnaire (QLQ-MEL38) is available for field testing in conjunction with the EORTC QLQ-C30. This study has shown that melanoma patients have important QoL issues that have been incorporated into a new cross-culturally validated instrument. Future testing of this EORTC module is planned and will be an important step forward in providing reliable QoL data to aid future decision-making in the management and clinical trials of this complex group of patients.

The importance of adequate primary tumor excision margins and sentinel node biopsy in achieving optimal locoregional control for patients with thick primary melanomas.

OBJECTIVE: This study sought to investigate the impact of histopathologically measured excision margins and SNB on local and locoregional disease control in patients with primary cutaneous melanomas more than 4 mm thick. BACKGROUND: Most current guidelines recommend at least a 2-cm surgical margin (which corresponds to a 16-mm histopathologic margin). These guidelines are based on limited evidence, mostly obtained in patients who did not have an SNB. METHODS: Histopathologic tumor excision margins for clinically lymph node-negative patients with melanomas more than 4 mm thick, treated at Melanoma Institute Australia (1992-2009), were determined. Clinicopathologic predictors of local and locoregional disease-free survival were investigated. RESULTS: There were 632 patients eligible for the study; of these, 397 (62.8%) had an SNB. The median histopathologic excision margin was 15 mm (interquartile range, 11.0-19.5 mm). After a median follow-up of 37 months, local and locoregional recurrences were observed in 48 (7.6%) and 159 (25.2%) patients, respectively. Excision margin as a continuous variable was a significant predictor of local [hazard ratio (HR), 0.91; P < 0.001) and locoregional (HR, 0.97; P = 0.042) tumor control on multivariate analyses. Patients with histopathologic margins 16 mm or less had worse local disease-free survival (HR, 2.41; P = 0.01). Patients who did not have an SNB were at higher risk of locoregional recurrence (HR, 1.67; P = 0.003). CONCLUSIONS: Histopathologically determined primary tumor excision margins more than 16 mm, corresponding to 2-cm surgical margins, were associated with better local control in patients with melanomas more than 4 mm thick. Patients achieved the best local and locoregional control when SNB was coupled with a more than 16-mm histologic excision margin.

What are the pertinent quality-of-life issues for melanoma cancer patients? Aiming for the development of a new module to accompany the EORTC core questionnaire.

Melanoma is the most serious type of skin cancer. However, there is a paucity of evidence on the impact of melanoma on the quality of life (QoL) of patients. Only two clinically validated QoL instruments have been reported in the literature. The present study has identified contemporary QoL issues during a time of great change for melanoma treatment, as a precursor to an international study to develop a new melanoma-specific QoL instrument. Twenty-two melanoma patients (American Joint Committee on Cancer stages I-IV) and 10 close family members were recruited from a metropolitan tertiary referral clinical and research centre in Sydney, Australia, to participate in interview or focus group discussions. Verbatim transcripts of these recorded interviews were systematically analysed. Seventy-three issues across seven health-related QoL domains were identified. Issues across three domains featured highly; psychosocial, availability of support and information. Given the current rapid evolution of systemic therapies for melanoma, the challenges associated with treatment choices and clinical trial participation were also highlighted in this sample. Although some issues were generic in nature, experienced by many cancer patients, this study revealed that the wide range and intensity of QoL issues reported by melanoma patients are not adequately evaluated in current QoL instruments. With the increasing importance of patient reported outcome measurement, this list has been transformed into questionnaire items, in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Group, for testing a new melanoma-specific QoL module for use with the EORTC core questionnaire (QLQ-C30).

The FACT-Melanoma quality-of-life instrument: comparison of a five-point and four-point response scale using the Rasch measurement model.

The FACT-Melanoma (FACT-M) is one of only two validated quality-of-life instruments designed specifically for use in patients with melanoma. The instrument incorporates FACT-G, followed by a set of questionnaire items that are specific to melanoma; all items are scored on a five-point response scale. The primary aim of this study was to evaluate the five-point response format of the FACT-M for goodness of fit to the Rasch measurement model, and to investigate whether rescoring the instrument using a four-point response format improved the psychometric properties. Two data sets of similar patient sample sizes (n=127 and 123) were used to test the reliability and validity of the generic instrument (FACT-G) to measure quality of life for patients with melanoma. The Additional Concerns and Melanoma Surgery subscales were subjected to a more detailed analysis using a combination of confirmatory factor analysis and Rasch analysis techniques. The Rasch model fit of the FACT-M was improved by the use of a four-point response format, together with the deletion of three items. Principal components analysis suggested that two melanoma-specific subscales existed within the Additional Concerns subscale and each could be reduced to seven items, respectively, with improved goodness of fit to the Rasch model. The FACT-M instrument showed improved fit to the Rasch model specifications when the items adopted a four-point response format. These results point to possible improvements in the content and structure of the FACT-M for use in future melanoma clinical trials. However, further study should be conducted with larger samples, selected by disease and treatment status.

Treatment and prognostic significance of positive interval sentinel nodes in patients with primary cutaneous melanoma.

BACKGROUND: Interval sentinel nodes (SNs) are lymph nodes receiving direct lymphatic drainage from a primary site and lying between the tumor and a recognized node field. It is not clear what further nodal surgery should be performed when interval nodes are found to contain micrometastatic disease. In this study, the incidence, location, and treatment of interval SNs in melanoma patients were analyzed to develop recommendations regarding the treatment of patients with interval SNs. METHODS: A retrospective review was undertaken of all patients with primary cutaneous melanoma who underwent lymphoscintigraphy at a single institution between 1992 and 2007. Data concerning the primary melanoma, location of SNs, treatment and survival were analyzed. RESULTS: Of 4895 patients who had a lymphoscintigram during the study period, 442 (9.0%) had an interval SN identified on lymphoscintigraphy. Interval SNs occurred significantly more often in patients with melanomas on the posterior trunk than in those with melanomas at other sites (P<0.001). A total of 197 patients (44.6%) with an identified interval SN underwent excision biopsy of the node. Of the 16 patients found to have metastatic melanoma in their interval SN, four also had negative SNs in a recognized lymph node field, and no other positive nodes were found on completion lymphadenectomy. CONCLUSIONS: Interval SNs are present in approximately 1 in 10 melanoma patients but are about half as likely to contain metastases as SNs in recognized node fields. If a positive interval SN is found, completion lymphadenectomy of the recognized lymph node field is only recommended if a SN in this field is also positive.

Lymph node ratio provides prognostic information in addition to american joint committee on cancer N stage in patients with melanoma, even if quality of surgery is standardized.

OBJECTIVE: To investigate whether lymph node ratio (LNR) gives additional prognostic information to American Joint Committee on Cancer (AJCC) N stage in a melanoma treatment center where regional lymph node dissection (RLND) techniques are standardized. BACKGROUND: Lymph node ratio is the ratio of involved lymph nodes to total number of lymph nodes removed at RLND. It is a predictor of survival for melanoma patients. One possible explanation of this is variation in surgical quality. METHODS: Regional lymph node dissection procedures performed between 1993 and 2006 were identified from a prospective melanoma database. Patients having axilla, groin, and neck (≥ 4 levels) RLNDs were allocated to both AJCC N stage groupings and LNR groupings using thresholds A 10% and less, B more than 10% to 25%, and C more than 25%. RESULTS: Lymph nodes retrieval for surgeons was equivalent or exceeded existing standards. For all RLNDs combined (n = 1514) and for the separate regions N1 and LNR A, N2 and LNR B, and N3 and LNR C all had similar numbers of patients allocated to each group with similar survival. The significant factors on multivariate analysis were LNR, primary melanoma Breslow thickness (but only when assessing AJCC stage T0-T3 vs T4), ulceration, AJCC N stage, age less than 50 years/50 years and more, and lymph node basin (groin better than axilla and neck). Lymph node ratio also allowed substaging of AJCC stage N3 patients. CONCLUSIONS: Standardized techniques for RLNDs result in LNR and AJCC N stage having similar percentages of cases in each grouping with similar survival. However, LNR is still an independent predictor in prognosis in these melanoma patients. Substaging may account for some of these observations.

The MCSS-26: revision of the Manchester Clinical Supervision Scale using the Rasch Measurement Model.

BACKGROUND: Previously published accounts of the evaluation of the effects of clinical supervision, a structured system to support health service staff, have been mainly contained to small scale qualitative studies. Over the past decade, the 36-item Manchester Clinical Supervision Scale (MCSS) has transformed the evaluation landscape and has been used as a quantitative outcome measure in upward of 90 licensed studies in 12 countries worldwide. The factor structure has been replicated by other researchers and the psychometric properties have been found robust. However, it had not been previously tested empirically using newly available and sophisticated statistical analyses. PURPOSE: This study tested the original factor structure and response format of the MCSS for goodness of fit to the Rasch model, using Rasch Unidimensional Measurement Model (RUMM) 2030 software, and investigated the validity of the questionnaire for both nursing and allied health (AH) staff. METHODS: A series of Rasch analyses were conducted on the seven subscales of the MCSS. The default procedure for RUMM software uses the partial credit model, which allows items to have varying numbers of response categories and does not assume the distance between response thresholds is uniform. RESULTS: Detailed Rasch analyses indicated that the 36-item version of the MCSS could be reduced to 26 items and result in improved fit statistics for six subscales rather than seven. CONCLUSIONS: This study reconfirmed the established psychometric properties of the MCSS, now renamed the MCSS-26.

A tool to measure whether business management capacity in general practice impacts on the quality of chronic illness care.

Our aim was to develop a tool to identify specific features of the business and financial management of practices that facilitate better quality care for chronic illness in primary care. Domains of management were identified, resulting in the development of a structured interview tool that was administered in 97 primary care practices in Australia. Interview items were screened and subjected to factor analysis, subscales identified and the overall model fit determined. The instrument's validity was assessed against another measure of quality of care. Analysis provided a four-factor solution containing 21 items, which explained 42.5% of the variance in the total scores. The factors related to administrative processes, human resources, marketing analysis and business development. All scores increased significantly with practice size. The business development subscale and total score were higher for rural practices. There was a significant correlation between the business development subscale and quality of care. The indicators of business and financial management in the final tool appear to be useful predictors of the quality of care. The instrument may help inform policy regarding the structure of general practice and implementation of a systems approach to chronic illness care. It can provide information to practices about areas for further development.

Clinical supervision: outsider reports of a research-driven implementation programme in Queensland, Australia.

AIM: The aim of the present study was to explore substantive issues related to the implementation of Clinical Supervision (CS). BACKGROUND: Historically, the treatment of mental illness in Australia has been inadequate. CS has shown promise as a positive contribution to the clinical governance agenda, as a structured staff support mechanism. EVALUATION: Within the wider context of a randomized controlled trial (RCT) of CS, semi-structured interviews (n = 17) were conducted with staff who worked alongside colleagues that attempted to implement CS. KEY ISSUES: Senior managers embraced CS and were disappointed when junior managerial colleagues did not hold a similar conviction, when tested by the realities of CS implementation. If CS was regarded as an additional activity, it stretched human resources and created inter-staff tensions. CONCLUSIONS: The personal testimony of these 'outsiders' spoke about the practicalities of implementing CS and the prevailing culture into which they were introduced. When perceived as a tour de force for culture change, CS was polarized as an opportunity by many, but also as a threat by some. IMPLICATIONS FOR NURSING MANAGEMENT: A single, cohesive and explicit management position on CS in each Health Service entity may obviate some of the impediments to CS implementation.

Lymphoma occurring in patients with cutaneous melanoma.

BACKGROUND: Non-melanoma malignancies are not uncommon in patients with melanoma. This study sought to determine the incidence of lymphoma in patients with melanoma compared with the general population, and to characterise their clinical and pathological features. METHODS: Patients diagnosed with melanoma and lymphoma between January 1992 and December 2007 were identified from the databases of Melanoma Institute Australia (MIA) and the Department of Tissue Pathology and Diagnostic Oncology, Royal Prince Alfred Hospital (RPAH). The clinical histories of the patients in the MIA database and pathology reports in the RPAH archives were reviewed. The incidence risk for melanoma and non-Hodgkin lymphoma was obtained from Australian Cancer Incidence and Mortality registry data. RESULTS: Of 18,226 patients with melanoma, 55 (0.3%) had lymphoma. Lymphoma was diagnosed subsequent to melanoma in 23 (41.8%) patients, prior to melanoma in 7 (12.7%) patients, and concurrently with melanoma in 25 (45.5%) patients. 53 (96.4%) patients developed non-Hodgkin lymphoma (NHL), the most common subtypes being chronic lymphocytic leukaemia/small lymphocytic lymphoma (49.1%), follicular lymphoma (23.6%) and diffuse large B-cell lymphoma (16.4%). Two (3.6%) patients developed Hodgkin lymphoma. Melanoma patients had a significantly higher risk of developing NHL than the general population (standardised incidence rate 3.5). CONCLUSIONS: A small but significant proportion of patients with melanoma develop lymphoma, either synchronously or metachronously. Lymph node specimens from melanoma patients might harbour lymphoma, and might represent the first recognised site of disease. A high index of suspicion for lymphoma when evaluating lymph nodes from patients with melanoma will ensure prompt diagnosis and appropriate management.