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Background We aimed to estimate minimally important difference (MID) for interpreting group-level change over time for European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in head and neck cancer. Methods Data were derived retrospectively from two published EORTC trials. Clinical anchors were selected using correlation strength and clinical plausibility of the given anchor/QLQ-C30 scale pair. MIDs for within-group and between-group change were estimated via the mean change method and linear regression, respectively. Distribution-based MIDs were also examined. MIDs for two of the scales, dyspnea and nausea/vomiting, are more uncertain considering their low correlations with the anchors. Results Anchor-based MIDs could be determined for deterioration in 7 of the 14 QLQ-C30 scales assessed, and in 3 scales for improvement. MIDs varied by scale, direction of change, and anchor. Absolute MID values ranged from 5 to 15 points for within-group change and 4 to 12 for between-group change. Most MIDs were within 4 to 10 points. Conclusions Our findings, if confirmed, will aid interpreting changes in selected QLQ-C30 scale scores over time and inform sample size calculations in future clinical trials in head and neck cancer.

Objective: Long‐term issues following diagnosis and treatment of a childhood brain tumour often become apparent as the survivor enters adolescence and young adulthood. Their caregivers may additionally face long‐term impacts on their emotional and psychological functioning. This review synthesised evidence on the issues and supportive care needs of adolescent and young adult (AYA) survivors of a brain tumour diagnosed in childhood and their caregivers. Methods: Electronic databases were searched up until September 2017. All studies reporting on issues or needs of childhood brain tumour survivors (aged 14‐39) and their caregivers were included. Narrative synthesis methods were used to summarise, integrate, and interpret findings. Results: Fifty‐six articles (49 studies) met the inclusion criteria. Social issues (ie, isolation and impaired daily functioning) were most commonly reported by survivors, followed by cognitive (ie, impaired memory and attention) and physical issues (ie, endocrine dysfunctions and fatigue). Survivors experienced poorer social functioning and sexual functioning and were less likely to be employed or have children, when compared with other AYA cancer survivors. Caregivers experienced reduced support as the survivor moved into young adulthood. Caregivers reported uncertainty, increased responsibilities, and problems maintaining their own self–well‐being and family relationships. Few studies reported on supportive care needs. Survivors expressed a need for better educational support and age‐specific psychosocial services. Conclusions: Surviving a childhood brain tumour can be particularly challenging for AYA survivors and their caregivers. Robust structured research is needed to identify specific support needs of both survivors and their caregivers and how these can be optimally addressed.

BACKGROUND: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment. METHODS: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group. RESULTS: The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, –2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea. CONCLUSIONS: The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer.

Aim The surgical management of locally recurrent rectal cancer (LRRC) has become widely accepted to afford cure and improve quality of life in this subset of patients. Thus far, traditional surgical and oncological markers have been used to highlight the success of surgical intervention. The use of patient-reported outcomes, specifically health-related quality of life (HRQoL), is sparse in these patients. This may be in part due to the lack of well-designed, validated instruments. This study identifies HRQoL issues relevant to patients undergoing surgery for LRRC, with the aim of developing a conceptual framework of HRQoL specific to LRRC to enable measurement of patient-reported outcomes in this cohort of patients. Method Qualitative focus groups were undertaken at two institutions to identify relevant HRQoL themes. The principles of thematic content analysis were used to analysis data. NViVo10 was used to analyse data. Results Twenty-one patients participated in six consecutive focus groups. Two patterns of themes emerged related to HRQoL and healthcare service delivery and utilization. Identified themes related to HRQoL included symptoms, sexual function, psychological impact, role and social functioning and future perspective. Under healthcare service and delivery and utilization the subdomain of disease management, treatment expectations and healthcare professionals were identified. Conclusion This is the first qualitative study undertaken exclusively in patients with LRRC to ascertain relevant HRQoL outcomes. The impact of LRRC on patients is wide-ranging and extends beyond traditional HRQoL outcomes. The study operationalizes the identified outcomes into a conceptual framework, which will provide the basis for the development of a LRRC-specific patient-reported outcome measure.

OBJECTIVE: We aim to describe the economic burden of UK cancer survivorship for breast, colorectal and prostate cancer patients treated with curative intent, 1 year post-diagnosis. METHODS: Patient-level data were collected over a 3-month period 12-15 months post-diagnosis to estimate the monthly societal costs incurred by cancer survivors. Self-reported resource utilisation data were obtained via the electronic Patient-reported Outcomes from Cancer Survivors system and included community-based health and social care, medications, travel costs and informal care. Hospital costs were retrieved through data linkage. Multivariate regression analysis was used to examine cost predictors. RESULTS: Overall, 298 patients were included in the analysis, including 136 breast cancer, 83 colorectal cancer and 79 prostate cancer patients. The average monthly societal cost was $US409 (95%CI: $US316-$US502) [mean: £260, 95%CI: £198-£322] and was incurred by 92% of patients. This was divided into costs to the National Health Service (mean: $US279, 95%CI: $US207-$US351) [mean: £177, 95%CI: £131-£224], patients' out-of-pocket (OOP) expenses (mean: $US40, 95%CI: $US15-$US65) [mean: £25, 95%CI: £9-£42] and the cost of informal care (mean: $US110, 95%CI: $US57-$US162) [mean: £70, 95%CI: £38-£102]. The distribution of costs was skewed with a small number of patients incurring very high costs. Multivariate analyses showed higher societal costs for breast cancer patients. Significant predictors of OOP costs included age and socioeconomic deprivation. CONCLUSIONS: This study found the economic burden of cancer survivorship is unevenly distributed in the population and that cancer survivors may still incur substantial costs over 1 year post-diagnosis. In addition, this study illustrates the feasibility of using an innovative online data collection platform to collect patient-reported resource utilisation information. Copyright © 2015 John Wiley & Sons, Ltd.

Objective: Studies have found that illness perceptions explain significant variance in health outcomes in numerous diseases. However, most of the research is cross-sectional and non-oncological. We examined, for the first time in breast, colorectal and prostate cancer patients, if cognitive and emotional illness perceptions near diagnosis predict future multidimensional health-related quality of life (HRQoL). Methods: UK-based patients (N = 334) completed the illness perception questionnaire-revised within 6 months post-diagnosis and the quality of life in adult cancer survivors scale 15 months post-diagnosis. Sociodemographic and clinical data were obtained from medical records. Hierarchical multiple regression analyses were conducted. Results: The sociodemographic and clinical factors collectively significantly predicted 8/12 HRQoL domains, although for 5/8 accounted for

The standardization of surgical techniques supplemented with appropriate neoadjuvant chemoradiation has led to the decline in local recurrence rates of rectal cancer (LRRC) from 25-50% to 5-10%. The outcomes reported for surgical intervention in LRRC is encouraging, however, a number of controversies exist especially in the ultra-advanced and palliative setting. Incorporating health-related quality of life (HRQoL) outcomes in this field could supplement traditional clinical endpoints in assessing the effectiveness of surgical intervention in this cohort. This review aimed to identify the HRQOL themes that might be relevant to patients with LRRC. A systematic review was undertaken to identify all studies reporting HRQoL in LRRC. Each study was evaluated with regards to its design and statistical methodology. A meta-synthesis of qualitative and quantitative studies was undertaken to identify relevant HRQoL themes. A total of 14 studies were identified, with 501 patients, with 80% of patients undergoing surgery. HRQoL was the primary endpoint in eight studies. Eight themes were identified: physical, psychological and social impact, symptoms, financial and occupational impact, relationships with others, communication with healthcare professionals and sexual function. The impact on HRQoL is multifactorial and wide ranging, with a number of issues identified that are not included in current measures. These issues must be incorporated into the assessment of HRQoL in LRRC through the development of a validated, disease-specific tool.

Objective Informational needs among cancer patients are similar, but the degree of information disclosure in different cultural areas varies. In this paper, we present the results of a cross-cultural study on information received. Methods The EORTC information questionnaire, EORTC QLQ-INFO25, was administered during the treatment process. This questionnaire evaluates the information that patients report they have received. Cross-cultural differences in information have been evaluated using statistical tests such as Kruskall–Wallis and multivariate models with covariates to account for differences in clinical and demographic characteristics across areas. Results Four hundred and fifty-one patients from three cultural areas, North–Middle Europe, South Europe, and Taiwan, were included in the study. Significant differences among the three cultural areas appeared in eight QLQ-INFO25 dimensions: information about the disease; medical tests; places of care; written information; information on CD/tape/video; satisfaction; wish for more information; and information helpfulness. North–Middle Europe patients received more written information (mean = 67.2 (North) and 33.8 (South)) and South Europe patients received more information on different places of care (mean = 24.7 (North) and 35.0 (South)). Patients from North–Middle Europe and South Europe received more information than patients from Taiwan about the disease (mean = 57.9, 60.6, and 47.1, respectively) and medical tests (70.9, 70.4, and 54.5), showed more satisfaction (64.8, 70.2, and 35.0), and considered the information more helpful (71.9, 73.9, and 50.4). These results were confirmed when adjusting for age, education, and disease stage. Conclusion There are cross-cultural differences in information received. Some of these differences are based on the characteristics of each culture. Copyright © 2011 John Wiley & Sons, Ltd.

Objective: Following publication of national guidelines on detection and management of psychosocial problems in oncology, this study explores frequency of discussion of emotional and social issues in outpatient oncology consultations.Methods: Analysis of baseline data from 212 outpatients participating in a randomized controlled trial. Baseline data included content analysis of audio recordings of consultations, Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire subscale scores, and patient and clinician self-rated preferences and perceptions of communication.Results: Fifty-nine percent patients and 75% clinicians expressed preferences to discuss emotional issues during consultations. Analysis of audio recordings showed that they were discussed in 27% of the consultations, regardless of severity of emotional problems reported by patients (FACT-G Emotional well-being subscale). Fifty percent of clinicians reported discussing emotional issues 'often' or 'almost always', compared with 18% of patients. Forty-four percent patients and 39% clinicians reported that they would discuss social activities, but they were actually discussed in 46% of consultations. Patients predominantly initiated discussion of emotional and social issues (85 and 60% consultations, respectively).Conclusions: Low prevalence of discussion of psychosocial issues cannot be accounted for by patient or clinician communication preferences. If clinicians rely on patients to initiate discussion of psychosocial issues, patients' problems may go unaddressed.

Objective: Emotional distress (ED) is an under-diagnosed problem in cancer patients and over the last decade a number of national guidelines have recommended an assessment and management model based on appropriate health professional response to a hierarchy of patient need. This study explores the views of cancer professionals regarding their current roles and responsibilities in the detection and management of ED, use of screening tools and access to expert psychological support. Methods: Interviews with 23 professionals were conducted [6 clinical nurse specialists (CNS), 8 oncologists, 4 surgeons and 5 ward sisters] from hospitals in Yorkshire, UK. Data were evaluated using framework analysis. Results: Detection of ED was seen to be the responsibility of the whole cancer team though nurses, particularly CNSs, are heavily depended upon to assess and manage distress. Experience of screening tools was limited and a number of reservations were expressed about routine implementation. A wide range of services are used to support distressed patients but a lack of referral guidance and access to specialist psychological care were reported to be a significant barrier to effective management. Conclusions: Cancer professionals describe working within the fundamental principles of the guidance frameworks; however, access to specialist support do not appear to meet recommendations, leaving the CNS with considerable responsibility for the detection and management of ED. Support for ED may be improved by the introduction of routine screening along with appropriate training and implementation of referral guidelines to assist professionals in accessing specialist psychology services. Copyright © 2011 John Wiley & Sons, Ltd.

Aims: To develop subscales for clinical use of the Social Difficulties Inventory (SDI) with score interpretation guidance for use in routine oncology practice. Background: Patient-reported outcome measures are used increasingly in cancer care but successful implementation is dependent on a combination of sound psychometrics, guidance on clinical meaning and good clinical judgement. The SDI, a 21-item instrument (SDI-21) developed for use in cancer care, demonstrated good psychometric properties. Rasch analysis of the SDI resulted in a 16-item interval scale of Social Distress (SD-16), which allowed for establishment of some clinical utility guidance but further work was required to optimise meaningful interpretation in clinical practice. Data sources: Data were pooled from three studies investigating psychometrics and clinical utility of the SDI-21. Statistical analyses: Common factor analysis was undertaken on SD-16 items. Subscales were derived from the resulting factors and calculated by summing the scores of associated items. Subscale reliability was evaluated using Cronbach's α. Results: There were 652 participants. A three-factor model explaining 53.3% of the variance was extracted forming the basis of the subscales: Everyday living, Money matters and Self and others. Subscale reliability was good. In a clinical setting, a 2-point change in subscale score could be interpreted as a clinically meaningful difference. Conclusion: The development of three subscales and clinically significant difference scores for the SD-16, combined with the previously developed cut-off points, improves the clinical utility of the SDI-21 when assessing social issues in oncology care. Copyright © 2010 John Wiley & Sons, Ltd.

Background: Implementation of guidance on assessment and management of psychosocial and supportive-care problems or needs will be successful only if consideration is given to existing skills, experience and expectations of staff and patients. This study examines the roles and responsibilities of staff, patients and families in relation to management of social difficulties and proposes a pathway for response. Methods: A qualitative study was performed using staff and patient interviews. Seventeen doctors and 16 nurses were interviewed using patient scenarios and a support service questionnaire. Patients (n = 41) completed a screening questionnaire (the Social Difficulties Inventory) and were interviewed. Interviews were audio-recorded, transcribed and subjected to a Framework analysis. Analysis examined (1) actions taken by staff and patients in response to social difficulties, (2) reasons given for action taken and (3) perceptions of staff and patients of who was responsible for taking action. Results: Staff were confident concerning clinically related issues (i.e. mobility) but more hesitant concerning difficulties related to money, work and family concerns. Patients liked to cope with problems on their own where possible, would have liked information or support from staff but were uncertain how to access this. Results led to development of a hierarchy of interventions in response to detected social difficulties. Discussion: For routine assessment of social difficulties, patients, nurses and doctors will have to work collaboratively, with nurses taking a lead in discussion. For specific clinically related problems doctors would play a more primary role. Copyright © 2010 John Wiley & Sons, Ltd.

The overall aim of this thesis was to characterize patient-physician communication in oncology care with focus on the content and quality of the consultations from the perspectives of patients, oncologists and observer. Further, the aim was to explore oncologists’ perceived barriers against psychosocial communication in out-patient consultations. Finally, the aim was to evaluate different methods for evaluating communication in this setting.Routine oncology out-patient consultations from two different hospitals were audio-recorded. After the consultations, patients and oncologists perceptions of the content and quality of the communication were assessed using a self-report questionnaire. A nation-wide survey was performed to assess oncologists’ perceived barriers against psychosocial communication. Finally, the audio-recorded consultations were used for evaluating inter-rater reliability and feasibility of two different communication analysis instruments.Patient-physician consultations in oncology care are focused on the physical aspects of disease and treatment, both in terms of how often these issues were discussed and in terms of the amount of time spent on discussing them. Psychosocial issues, such as the disease’s effects on patients’ emotional or social functioning, are not always discussed during consultations, and the time spent on such discussions is limited. When psychosocial issues are discussed during the medical consultations, they are most often patient-initiated. Reasons for why psychosocial aspects are seldom discussed during the medical consultations can be the barriers concerning this kind of communication perceived by a large majority (93%) of the oncologists. Barriers against psychosocial communication were identified at organizational levels (including guidelines, routines, and resources) and individual levels (including physicians’ knowledge and attitudes).Furthermore, this thesis shows that there are methods with high feasibility and reliability for evaluating the content of patient-physician communication, in large study samples in oncology care. The method (observation/self-report) and perspective (patient, physician, and observer) used when evaluating communication affects the results. This needs to be considered when choosing evaluation methods in intervention studies.There are reasons to continue to evaluate, promote and implement promising ways of achieving better communication in clinical practice. Research should focus on how to overcome barriers against psychosocial communication.

Background Decision aids help patients make informed treatment decisions. Values clarification (VC) techniques are part of decision aids that help patients assimilate the information with their personal values. There is little evidence that these techniques contribute to enhanced decision making over and above the provision of good quality information. Objectives To assess whether VC techniques are active ingredients in enhancing informed decision making and explain how and why they work. Methods Participants were randomly assigned to one of three groups: (i) information only, (ii) information plus implicit task, (iii) information plus explicit task. Thirty healthy women from a UK University participated by making a hypothetical choice between taking part in a clinical trial and having the standard treatment for breast cancer. Verbal protocols were elicited by think-aloud method and content analysed to assess informed decision making; a questionnaire was completed after the decision assessing decision preference, perceptions of decisional conflict and ambivalence. Data were analysed using multivariate statistics. Findings No participants changed their decision preference as a result of the VC techniques. Women in the explicit VC group evaluated more information in accord with personal values, expressed lower ambivalence, decisional uncertainty and greater clarity of personal values than those in the implicit VC and control groups. Feelings of ambivalence about both options were related to decisional conflict. Conclusion Explicit VC techniques are likely to be active ingredients in decision aids. They work by enabling people to deliberate about the decision information in accord with their personal values, which is associated with a better decision experience.

Objective: To validate an item bank for assessing and detecting psychological distress in cancer patients by (1) identifying whether additional items are required in the full item bank; (2) identifying any item bias in the existing item bank; (3) linking levels of distress against thresholds derived from gold-standard psychiatric interviews (PSE/SCAN/SCID). Method: A Rasch analysis was conducted on a heterogeneous sample of cancer patients (n=4919) who had completed a combination of eight psychological distress screening instruments. A subset of patients had completed a psychiatric interview along with the HADS (n=381) or PHQ-9 (n=440). Item thresholds were plotted along the latent trait. Furthermore, items were assessed for differential item functioning (DIF) by age and gender. Finally, optimum thresholds were derived for the HADS and PHQ-9 and plotted along the latent trait distribution for the entire item bank. Result: Item thresholds exceeded the range of person measures, although a gap was still present along the latent trait. No DIF was observed for either age or gender. Putative cut-offs were derived for the item bank detecting moderate to severe levels of psychological distress. Conclusion: The item bank covers the majority of levels of emotional distress reported by cancer patients. Additionally, initial thresholds have been derived on the item bank, which correspond to a formal psychiatric assessment. Further work is required to ascertain the stability of the item bank over time and by diagnosis and stage of disease, as well as to determine additional thresholds for levels of distress.

The Hospital Anxiety and Depression Scale (HADS) is widely used as a tool for assessing psychological distress in patients and non-clinical groups. Previous studies have demonstrated conflicting results regarding the factor structure of the questionnaire for different groups of patients, and the general population. This study investigated the factor structure of the HADS in a large heterogeneous cancer population of 1474 patients. It also sought to investigate emerging evidence that the HADS conforms to the tripartite model of anxiety and depression (Clark & Watson, 1993), and to test the proposal that detection rates for clinical cases of anxiety and depression could be enhanced by partialling out the effects of higher order factors from the HADS (Dunbar et al., 2000). The results demonstrated a two-factor structure corresponding to the Anxiety and Depression subscales of the questionnaire. The factor structure remained stable for different subgroups of the sample, for males and females, as well as for different age groups, and a subgroup of metastatic cancer patients. The two factors were highly correlated (r =.52) and subsequent secondary factor analyses demonstrated a single higher order factor corresponding to psychological distress or negative affectivity. We concluded that the HADS comprises two factors corresponding to anhedonia and autonomic anxiety, which share a common variance with a primary factor namely psychological distress, and that the subscales of the HADS, rather than the residual scores (e.g. Dunbar et al., 2000) were more effective at detecting clinical cases of anxiety and depression.

A multiple myeloma-specific quality-of-life questionnaire module has been designed in collaboration with the EORTC Quality-of-Life Study Group to be used in clinical trials with the EORTC QLQ-C30, a general cancer questionnaire. Strict methodology was employed to ensure thorough and appropriate development of the module. An extensive literature review was performed to identify health-related quality-of-life issues relevant to patients with multiple myeloma. Semi-structured interviews were then carried out in several European countries with health-care providers experienced in the treatment of patients with multiple myeloma, and with a group of patients with multiple myeloma, to identify the issues which were most important to patients. A questionnaire was devised from the list of issues, using a 1-week time-frame and response categories consistent with the EORTC QLQ-C30. The provisional questionnaire and the EORTC QLQ-C30 were administered to patients with multiple myeloma in each participating country with further semi-structured interviews to refine the content and design of the questionnaire. A review of the results obtained in each stage of development resulted in a 24-item myeloma-specific module, the EORTC QLQ-MY24, which assesses disease-specific symptoms and their impact on everyday life, treatment side-effects, social support, and future perspective. The module is currently undergoing further international field-testing to assess its psychometric properties.