Long-term health-related quality of life in head and neck cancer survivors: A large multinational study.

Head and neck cancer (HNC) patients suffer from a range of health-related quality of life (HRQoL) issues, but little is known about their long-term HRQoL. This study explored associations between treatment group and HRQoL at least 5 years' post-diagnosis in HNC survivors. In an international cross-sectional study, HNC survivors completed the European Organization for Research and Treatment of Cancer (EORTC) quality of life core questionnaire (EORTC-QLQ-C30) and its HNC module (EORTC-QLQ-H&N35). Meaningful HRQoL differences were examined between five treatment groups: (a) surgery, (b) radiotherapy, (c) chemo-radiotherapy, (d) radiotherapy ± chemotherapy and neck dissection and (e) any other surgery (meaning any tumour surgery that is not a neck dissection) and radiotherapy ± chemotherapy. Twenty-six sites in 11 countries enrolled 1105 survivors. They had a median time since diagnosis of 8 years, a mean age of 66 years and 71% were male. After adjusting for age, sex, tumour site and UICC stage, there was evidence for meaningful differences (10 points or more) in HRQoL between treatment groups in seven domains (Fatigue, Mouth Pain, Swallowing, Senses, Opening Mouth, Dry Mouth and Sticky Saliva). Survivors who had single-modality treatment had better or equal HRQoL in every domain compared to survivors with multimodal treatment, with the largest differences for Dry Mouth and Sticky Saliva. For Global Quality of Life, Physical and Social Functioning, Constipation, Dyspnoea and Financial Difficulties, at least some treatment groups had better outcomes compared to a general population. Our data suggest that multimodal treatment is associated with worse HRQoL in the long-term compared to single modality.

Originalbeiträge (Originals). Belastung(sgrenz)en für Psychotherapeut:innen nach der Reform.

Loads and limits for outpatient psychotherapists after the reform Objectives: The reform of the psychotherapy directive in 2017 challenged psychotherapists by new obligations and processes. We investigated burdens psychotherapists experience due to the reform and differences concerning urban vs. rural region, half vs. full care license and psychotherapy method. METHODS: Of 128 psychotherapists approached, 41 (32 %) agreed to study participation. Semistructured interviews were examined via qualitative content analysis. RESULTS: 83 % (n = 34) expressed some kind of burden. Burdens in terms of time, pressure/ stress and having to decline patients were named most frequently. 54 % of the participants (n = 22) pointed out various limits to what they can accomplish, mostly related to shortened waiting times and treatment availability. Burdens were more common among psychotherapists with a half care license and behavioural therapy; there were no major differences between urban or rural residents. DISCUSSION: Burdens for psychotherapists may result from individual life situations and resources of treatment availability.

Profile of the multicenter cohort of the German Cancer Consortium's Clinical Communication Platform.

Treatment concepts in oncology are becoming increasingly personalized and diverse. Successively, changes in standards of care mandate continuous monitoring of patient pathways and clinical outcomes based on large, representative real-world data. The German Cancer Consortium's (DKTK) Clinical Communication Platform (CCP) provides such opportunity. Connecting fourteen university hospital-based cancer centers, the CCP relies on a federated IT-infrastructure sourcing data from facility-based cancer registry units and biobanks. Federated analyses resulted in a cohort of 600,915 patients, out of which 232,991 were incident since 2013 and for which a comprehensive documentation is available. Next to demographic data (i.e., age at diagnosis: 2.0% 0-20 years, 8.3% 21-40 years, 30.9% 41-60 years, 50.1% 61-80 years, 8.8% 81+ years; and gender: 45.2% female, 54.7% male, 0.1% other) and diagnoses (five most frequent tumor origins: 22,523 prostate, 18,409 breast, 15,575 lung, 13,964 skin/malignant melanoma, 9005 brain), the cohort dataset contains information about therapeutic interventions and response assessments and is connected to 287,883 liquid and tissue biosamples. Focusing on diagnoses and therapy-sequences, showcase analyses of diagnosis-specific sub-cohorts (pancreas, larynx, kidney, thyroid gland) demonstrate the analytical opportunities offered by the cohort's data. Due to its data granularity and size, the cohort is a potential catalyst for translational cancer research. It provides rapid access to comprehensive patient groups and may improve the understanding of the clinical course of various (even rare) malignancies. Therefore, the cohort may serve as a decisions-making tool for clinical trial design and contributes to the evaluation of scientific findings under real-world conditions.

A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire.

PURPOSE: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting. METHODS: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach's α, and intra-class correlation coefficient). RESULTS: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68-0.92) and test-retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items. CONCLUSION: The Oslo COVID-19 QLQ-W61© is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed.

Awareness, offer, and use of psychosocial services by breast cancer survivors in Germany: a prospective multi-centre study.

PURPOSE: This study examined the pattern of psychosocial care in breast cancer survivors. METHODS: In a prospective study with measurements before surgery, 1 month, 8 months, and 5 years thereafter, we examined the proportion of breast cancer survivors who were aware about, had been offered and received various types of psychosocial services from psychologists, social workers, doctors, self-help groups etc. The degree of helpfulness per service among users was ascertained with Likert scales. Determinants of awareness, offer and use were investigated using binary logistic regression analyses. How the services are inter-related was tested with principal component analyses. RESULTS: Among 456 breast cancer survivors who participated until 5 years, psychological services were known by 91%, offered to 68%, and used by 55% of patients. Social services were known by 86%, offered to 65%, and used by 51%. Women ≥ 65 years were less likely to be informed about (odds ratio (OR) 0.2) and get offers for psychosocial services (OR 0.4 for social and 0.5 for psychological services) than women < 65 years. The services rated most helpful were social services in the hospital, psychological counselling by a consultant and psychotherapy in private practices. CONCLUSION: These findings underline the importance of psychosocial support by physicians in addition to the "professional" mental health and social care providers. They also show that elderly women in need for support might be in danger of not being well-informed about the services available.

Association of social service counseling in breast cancer patients with financial problems, role functioning and employment-results from the prospective multicenter BRENDA II study.

BACKGROUND: This study examined the relationship between social service counseling (SSC) and financial and role functioning problems in primary breast cancer (BC) patients over a 5-year observation period. METHODS: In the multicenter prospective study, patients were approached before surgery (t1), before initiation of adjuvant treatment (t2), after therapy completion (t3), and 5 years after surgery (t4). We examined the proportion of BC survivors who had financial and role functioning problems and the proportion who were employed at t4. We examined how frequently patients were informed about, offered, or used SSC, and we used multivariate logistic regression analyses to examine the relationship between this and financial and role functioning problem prevalence. RESULTS: Of the 456 BC survivors, 33% had financial problems and 22% reported role functioning problems at t4. There was no evidence that women with increased financial problems were informed about SSC more often than those without (OR 1.1, p = 0.84) or that they used SSC more often (OR 1.3, p = 0.25). However, women with role functioning problems were informed about SSC significantly more often (OR 1.7, p = 0.02) and attended counseling significantly more often (OR 1.6, p = 0.03). Among participants aged < 65 years at t4 (n = 255), 70% were employed. Patients who had received SSC were more likely to be employed at t4 than patients who did not (OR 1.9, p = 0.04). CONCLUSION: These findings underline the importance of SSC for BC patients with role functioning issues. They indicate that individuals who use SSC are more likely to be employed later on than individuals who do not.

[Outpatient Psychotherapy Before and After the Reform of the Psychotherapy Directive of 2017: Data from Practices with and without Psycho-Oncologic Specialty]. / Zustandekommen von ambulanter Psychotherapie vor und nach der Psychotherapiestrukturreform von 2017 ­ Daten aus Praxen mit und ohne psychoonkologischem Schwerpunkt .

BACKGROUND: The reform of the German psychotherapy directive in 2017 resulted in several changes for non-hospital-based psychotherapists. We examined whether patients received psychotherapy following their initial consultation more frequently after the reform than before. METHODS: Using records from psychotherapy practices in a retrospective cohort study, we investigated the frequency of a psychotherapy after the patients' initial consultation. We compared a time frame of three years before and after the reform. A potential association between reform and psychotherapy received was analysed via logistic regression. RESULTS: Our analysis comprised 1548 records from 9 psychotherapy practices, consisting of 755 records before and 793 records after the reform. Before the reform, 40% (n=303) of the patients who had an initial consultation went on to receive psychotherapy. After the reform, 46% (n=360) of initial consultations were followed by psychotherapy (including acute care). The logistic regression analysis showed a 36% increased probability of receiving psychotherapy after an initial consultation after the reform in comparison to before the reform (odds ratio 1.36 after vs. before reform, 95% confidence interval 1.09 - 1.68). CONCLUSION: Our results indicate a higher chance of receiving psychotherapy after an initial consultation after the reform compared to before the reform. Our data do not contain information as to whether the absolute number of psychotherapy appointments in the practices increased after the reform.

["It's Left a Bitter Taste" Psychotherapists' Perspectives on the Abolition of the German Assessment Procedure for Outpatient Psychotherapy]. / "Es hat so einen etwas bitteren Beigeschmack" Die Abschaffung des Antrags- und Gutachterverfahrens aus Sicht von Psychotherapeut*innen in der ambulanten Versorgung.

BACKGROUND AND RESEARCH QUESTION: In 2019, the abolition and replacement of the present German assessment procedure for outpatient psychotherapy was resolved and adopted into law. This study examined what psychotherapists think about the new plan. METHODS: We conducted semi-guided interviews with psychotherapists about their experience and opinion of the current psychotherapeutic care situation in Germany. Statements about the assessment procedure were evaluated using qualitative text analyses. We compared the psychotherapists' opinion on the assessment procedure with the psychotherapeutic approach as well as the age group. RESULTS: Of 41 psychotherapists 27 reported their thoughts about the assessment procedure. The following themes could be drawn from their statements: Appreciation as well as criticism of quality control of the procedure, worries about a future loss of economic and treatment certainty, perception that the assessment procedure questions one's competence, disapproval of the low remuneration of the reports, the connection between individual attitudes towards the assessment report and conscientiousness in writing the reports, and the lack of transparency of the legislative initiative. Psychodynamic psychotherapists wanted to keep the assessment procedure slightly more often compared to behavioural psychotherapists; child and youth psychotherapists wanted to keep it more often than psychotherapists for adults. DISCUSSION: Psychotherapists perceive the reform of the assessment procedure as a process with a substantial impact on their current clinical practice as well as their psychotherapeutical identity. To improve the quality and acceptance of the future quality assurance procedure, psychotherapists should be an active part of the development process.

Suicidal ideation and attempts in adults seeking outpatient psychodynamic psychotherapy.

Suicide is an important cause of death in patients with mental health disorders, but little is known about the occurrence of suicidal ideation and attempts in outpatient psychotherapy patients. The aim of this study was to identify the proportion of patients with and correlates of suicidal ideation and attempts in community-based psychotherapy practices. Using 983 applications for reimbursement of psychotherapy from individual patients, reports about suicidal thoughts and suicide attempts were extracted along with demographic, biographic and clinical data. Multivariate logistic regression analysis was used to identify correlates of suicidal ideation and attempts by calculating odds ratios (ORs). Among the patients, 19% presented with suicidal thoughts (11% currently and 8% in the past) and 6% with suicide attempts. Important correlates of suicidal thoughts were male gender (OR 1.7), lower education (OR 1.8), early retirement (OR 2.9), death of a parent when younger than 5 years old (OR 3.3), violence experienced from various people (OR 2.1), self-harm behaviour (OR 7.9) and alcohol misuse (OR 1.7). Suicide attempts were associated with male gender (OR 5.6), lower education (OR 4.2), violence experienced from partner (OR 2.5) or from various people (OR 9.5) and self-harm behaviour (OR 15.0). These results show that the proportion of suicidal patients seeking outpatient psychotherapy is high. It should therefore be a central topic in clinical training. Biographic data such as the loss of a parent at an early age or experiencing violence are associated with who is at increased risk and should be explored in detail.

[Patient-reported outcomes in head and neck cancer treatment: relevance, challenges, and benefit]. / Patientenberichtete Endpunkte in der Kopf-Hals-Tumortherapie: Relevanz, Herausforderungen und Nutzen.

Next to overall survival, quality of life is becoming more and more pivotal for cancer patients. The various domains of quality of life are complex and have different value to each patient. However, not only patients but also health care professionals, the pharmaceutical industry, and regulatory bodies ask: How can quality of life be reliably ascertained in clinical trials? For this purpose, carefully developed and validated specific questionnaires are needed: the patient-reported outcome measures (PROMs). A key challenge is to define how results based on PROMs can be used for shared decision-making. Next to clinical factors such as health and nutritional status, quality of life acts as a prognostic factor for overall survival in cancer. Thus, it is crucial to take quality of life into account in daily clinical practice.

[Psychotherapeutic appointments given by Associations of Statutory Health Insurance Physicians in 2019 : An analysis differentiated by appointment type and region]. / Vermittlung der Terminservicestellen Psychotherapie im Jahr 2019 : Eine Auswertung differenziert nach Vermittlungsanliegen und KV-Region.

BACKGROUND: One provision of the Care Provision Strengthening Act in Germany was that psychotherapeutic appointments (psychotherapeutic consultation, acute care, and probatory sessions) are now arranged through the Association of Statutory Health Insurance Physicians organizations. We examined how many appointments were requested and given in 2019, differentiated by appointment type and by city state versus areal state organizations. METHODS: The frequency of requests and appointments made in 2019 were collected from the Association of Statutory Health Insurance Physicians organizations in Germany using a questionnaire. Statistical analysis comprised descriptive evaluations and a Kruskal-Wallis test. RESULTS: Data for appointments were available from 17 and information on requests from 16 Association of Statutory Health Insurance Physicians organizations. A total of 134,578 appointments were given. The number of granted appointments ranged from 193 to 21,810, revealing substantial differences between the individual organizations. The share of psychotherapeutic consultations among all psychotherapeutic appointments granted amounted to a median of 92%. Per organization, appointments were given for a median of 87% of requests for a psychotherapeutic consultation (range 56-100%), 96% for acute care requests (range 29-100%), and 97% for probatory session requests (range 27-100%) (n = 16, respectively). There were minor differences between city states and areal states in granting acute care and probatory sessions. DISCUSSION: There are deficits both in city state and areal state Association of Statutory Health Insurance Physicians organizations in terms of granting acute care and probatory sessions. Our results do not allow conclusions about distance to the practices or waiting times.

The association of Health-Related Quality of Life and 1-year-survival in sarcoma patients-results of a Nationwide Observational Study (PROSa).

BACKGROUND: Sarcomas are rare cancers of high heterogeneity. Health-Related Quality of Life (HRQoL) has been shown to be a prognostic factor for survival in other cancer entities but it is unclear whether this applies to sarcoma patients. PATIENTS AND METHODS: HRQoL was prospectively assessed in adult sarcoma patients from 2017 to 2020 in 39 German recruiting sites using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Vital status was ascertained over the course of 1 year. HRQoL domains were analysed by multivariable cox-regressions including clinical and socio-economic risk factors. RESULTS: Of 1102 patients, 126 (11.4%) died during follow-up. The hazard ratio (HR) for global health was 0.73 per 10-point increase (95% confidence interval (CI) 0.64-0.85). HR for the HRQoL-summary score was 0.74 (CI 0.64-0.85) and for physical functioning 0.82 (CI 0.74-0.89). There was also evidence that fatigue (HR 1.17, CI 1.10-1.25), appetite loss (HR 1.15, CI 1.09-1.21) and pain (HR 1.14, CI 1.08-1.20) are prognostic factors for survival. CONCLUSION: Our study adds sarcoma-specific evidence to the existing data about cancer survival in general. Clinicians and care-givers should be aware of the relations between HRQoL and survival probability and include HRQoL in routine assessment.

What are predictors of impaired quality of life in patients with hypoparathyroidism?

CONTEXT: Hypoparathyroidism (hypoPT) is a rare endocrine disorder. Little is known about what factors are associated with potential quality of life (QOL) impairments. DESIGN: HypoPT patients at a minimum of 6 months' post diagnosis were invited to participate in an online survey through their treating physician or through self-help organisations METHODS: Impairments of clinical importance in QOL were considered present if the score of the respective functioning scale of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 exceeded a pre-defined threshold. Symptom burden was assessed using the HPQ-28. Multivariate logistic regression was used to identify factors associated with impairments in QOL. RESULTS: Data were available for 264 hypoPT patients. Impairments of clinical importance in QOL were reported for 40.4% in role functioning (RF), 40.6% in social functioning (SF), 60.8% in physical functioning (PF), 65.5% in cognitive functioning (CF) and 76.0% in emotional functioning (EF). Higher odds for reporting impaired QOL were seen for higher symptom burden (for almost all domains) and for being unable to work (for PF, RF and SF). Surgery for thyroid cancer being the cause of hypoPT was associated with lower odds in PF for patients and in PF and CF for patients with surgery for other thyroid-related diseases being the hypoPT cause. CONCLUSIONS: HypoPT needs to be recognised as a disease which might be associated with impaired QOL and affect daily living. Symptom management is crucial for improving QOL in hypoPT patients but socioeconomic factors like work-ability need to be considered when treating hypoPT patients.

"That was a tip from my physician"-Gender-specific pathways of patients and relatives to outpatient psychosocial cancer counselling centres-A qualitative study.

OBJECTIVE: This study aims to identify pathways patients and their relatives take to outpatient psychosocial cancer counselling centres. We had a special interest in how access for men can be eased. METHODS: Cancer patients and relatives were purposively sampled in two regions in Germany. Participants were either outpatient cancer counselling centres (OCCCs) users or non-users and participated in qualitative face-to-face interviews. We used different guidelines for users and non-users. The interviews were analysed using content analysis. RESULTS: One hundred and three people participated in the study. Important pathways to outpatient psychosocial cancer counselling centres for both men and women were: information about the service and its content, easy access (obtaining appointments quickly and without bureaucracy, close to home), and recommendations from another person, in particular from their treating physician. Pathways especially important for men are positive and repeated recommendations from their treating physician and other people they trust, organisation by others on the men's behalf, the Internet, the possibility to talk to a male counsellor, making it a routine in the hospital to refer distressed patients to the counselling services, and the emphasis on information sharing. Women reported more often than men that they discovered and accessed OCCCs via information material. CONCLUSIONS: Men in particular need recommendations from others, especially from their treating physician, in order to make use of psychosocial cancer counselling. In addition, stressing the provision of information instead of exploring and expressing emotions can ease access for men to cancer counselling.

Distress in soft-tissue sarcoma and gastrointestinal stromal tumours patients-Results of a German multicentre observational study (PROSa).

OBJECTIVE: Soft tissue sarcomas (STS) and gastrointestinal stromal tumours (GIST) are a group of rare malignant tumours with a high and heterogenous disease burden. As evidence is scarce, we analysed the prevalence of increased emotional distress and identified distress-associated factors in these patients. METHODS: The PROSa-study (Burden and medical care of sarcoma) was conducted between 2017 and 2020 in 39 study centres. Cross-sectional data from adult STS and GIST patients were analysed. Distress was measured with the Patient Health Questionnaire (PHQ-4). The relation of socioeconomic and clinical factors with distress was explored in adjusted logistic regression models. RESULTS: Among 897 patients, 17% reported elevated anxiety and 19% reported depression. Unemployed patients (odds ratio [OR] 6.6; 95% CI 2.9-15.0), and those with a disability pension (OR 3.1; 95% CI 1.9-5.0) were more likely to experience distress compared to employed patients. Also, patients with a disability pass had higher odds of increased distress than those without (OR 1.8; 95% CI 1.2-2.7). Lowest distress was observed in patients 2 to <5 years and ≥5 years after diagnosis (comparison: <6 months) (OR 0.4; 95% CI 0.2-0.6) and (0.3; 95% CI 0.2-0.6). Patients with thoracic STS (vs. lower limbs) had twice the odds to experience distress (OR 2.0; 95% CI 1.1-3.6). Distress was seen almost twice as often in patients with progressive disease (vs. complete remission) (OR 1.7; 95% CI 1.1-2.8). CONCLUSION: The prevalence of elevated distress in STS and GIST patients is high. In unemployed patients, in those with a disability pension and in newly diagnosed patients a noticeable increase was observed. Clinicians should be aware of these factors and consider the social aspects of the disease.

'I thought I had fibroids, and now I don't': a mixed method study on health-related quality of life in uterine sarcoma patients.

BACKGROUND: Uterine sarcomas are rare subtypes of primary urogenital tumours and need tailored treatment. This study aimed to examine the impact of diagnosis and treatment on health-related quality of life (HRQoL) in patients with uterine sarcoma and measures available to assess HRQoL in this group. METHODS: Thirteen patients with uterine sarcoma and 23 health care professionals were purposively sampled from sarcoma reference centers and participated in a semi-structured interview exploring HRQoL. Patients were also asked to review the EORTC QLQ-C30 and EORTC QLQ-EN24 for relevance. Data were analysed using thematic analysis and descriptive statistics. RESULTS: The most commonly reported physical health issues were related to sexual dysfunction and urological symptoms. Hormone-related issues and gastrointestinal symptoms were also identified. Cancer-generic issues such as functional problems, fatigue, pain, and treatment-related adverse effects were also reported. Regarding mental health, fears (about having sex, of recurrence, or of death), altered body-image, and dealing with lacking knowledge regarding sarcoma had an impact on HRQoL. Social health issues were related to the impact on relationships with others, limitations in undertaking activities, loss of independence, changes in work or study capacity, and financial difficulties. Most of the items of the EORTC QLQ-C30 and EORTC QLQ-EN24 questionnaires were rated as relevant. Questions about lack of knowledge about sarcoma, shock of diagnosis, and menopausal symptoms were lacking from existing measures. CONCLUSIONS: Uterine sarcoma patients experience a variety of concerns covering the physical, mental, and social domains of HRQoL that are in the main EORTC instruments, but not all of them. Combining cancer-generic, location- and sarcoma-specific items is recommended to assess HRQoL in this patient group. Trial registration NCT04071704.

Financial toxicity in sarcoma patients and survivors in Germany: results from the multicenter PROSa study.

PURPOSE: Cancer patients have been shown to frequently suffer from financial burden before, during, and after treatment. However, the financial toxicity of patients with sarcoma has seldom been assessed. Therefore, the aim of this study was to evaluate whether financial toxicity is a problem for sarcoma patients in Germany and identify associated risk factors. METHODS: Patients for this analysis were obtained from a multicenter prospective cohort study conducted in Germany. Using the financial difficulties scale of the EORTC QLQ-C30, financial toxicity was considered to be present if the score exceeded a pre-defined threshold for clinical importance. Comparisons to an age- and sex-matched norm population were performed. A multivariate logistic regression using stepwise backward selection was used to identify factors associated with financial toxicity. RESULTS: We included 1103 sarcoma patients treated in 39 centers and clinics; 498 (44.7%) patients reported financial toxicity. Sarcoma patients had 2.5 times the odds of reporting financial difficulties compared to an age- and sex-matched norm population. Patient age < 40 and > 52.5 years, higher education status, higher income, and disease progression (compared to patients with complete remission) were associated with lower odds of reporting financial toxicity. Receiving a disability pension, being currently on sick leave, and having a disability pass were statistically significantly associated with higher odds of reporting financial toxicity. CONCLUSION: Financial toxicity is present in about half of German sarcoma patients, making it a relevant quality of life topic for patients and decision-makers.

Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing scale.

PURPOSE: The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. METHODS: In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. RESULTS: From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from - 3 to - 14. CONCLUSIONS: For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.

Predictors of psychiatric comorbidity in cancer patients at the time of their discharge from the hospital.

PURPOSE: A cancer diagnosis can have a substantial impact on one's mental health. The present study investigated the prevalence and predictors of psychiatric comorbidities in cancer patients at the time of their discharge from the hospital. METHODS: Psychiatric comorbidities were assessed shortly before hospital discharge and half a year after hospitalization using a structured clinical interview (SCID), based on the diagnostic and statistical manual of mental disorders (DSM-IV). Frequencies at both time points were estimated using percentages and corresponding 95% confidence intervals. Predictors of mental disorders were identified using binary logistic regression models. RESULTS: At time of hospital discharge, 39 out of 334 patients (12%) were diagnosed with a psychiatric comorbidity, and 15 (7%) were diagnosed half a year later. Among the diagnoses, adjustment disorders (3%) were most frequent at the time of hospital release, while major depression (3%) was the most frequent 6 months later. Having a mental disorder was associated with unemployment (odds ratio (OR) 3.4, confidence interval (CI) 1.1-10.9, p = 0.04). There was no evidence that school education (OR 2.0, CI 0.4-9.0, p = 0.38), higher education (OR 0.7, CI 0.2-2.4, p = 0.60), income (OR 1.0, CI 1.0-1.0, p = 0.06), tumor stage (OR 1.1, CI 0.4-3.2, p = 0.85), type of disease (OR 0.6, CI 0.2-2.1, p = 0.47), pain (OR 1.0, CI 1.0-1.0, p = 0.15), fatigue (OR 1.0, CI 1.0-1.0, p = 0.77), or physical functioning (OR 1.0, CI 1.0-1.0, p = 0.54) were related to the presence of a psychiatric comorbidity. CONCLUSIONS: Unemployment was associated with at least a threefold increased risk of mental disorder, which highlights the need for special attention to be given to this subgroup of cancer patients.

Course of social support and associations with distress after partial laryngectomy.

PURPOSE: Social support has been shown to be positively associated with quality of life and adjustment after a cancer diagnosis. The present study investigates the course of social support up to one year after partial laryngectomy and its association with distress. DESIGN: Longitudinal questionnaire study. SAMPLE: A total of 428 patients after partial laryngectomy (mean age: 64, SD = 11, 91% male). METHODS: Patients completed questionnaires before treatment (t1), one week after a partial laryngectomy (t2), 3 months (t3), and one year (t4) thereafter. Social support was evaluated at t2, t3, and t4 using a brief version of the Social Support Questionnaire. Distress was measured at t2, t3, and t4 using the HADS. Descriptive statistics for social support were computed across the three measurement points. Changes were analyzed by Wilcoxon signed-rank tests. Associations with distress were identified using linear regression analyses. FINDINGS: Social support increased between t2 and t3 and decreased to baseline level between t3 and t4. Distress at t2 was associated with social support at t2 (B = -0.15, p < 0.01) and distress at t3 with social support at t3 (B = -0.19, p < 0.01). Distress at t4 was related to social support at t2 (B = -0.10, p = 0.05). CONCLUSIONS: Although perceived social support increases after partial laryngectomy, it decreases again during the course of aftercare. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS OR POLICY: Social support resources should be assessed to identify patients at risk for worse psychological well-being.