Screening and assessment for cancer patients' psychosocial support needs: Development and validation of the psychosocial risk questionnaire.

PURPOSE: Psychosocial factors can negatively influence the ability to cope with cancer-specific therapy. To identify high-risk patients and to offer need-based care concerning social issues, valid, reliable, and economic instruments are needed. This study aims to develop a tool assessing psychosocial support needs and analyze its psychometric properties. METHODS: Based on an extensive literature search, items for the scale of psychosocial risks (PSR) were developed to assess the need for psychosocial support. Overall, N = 343 participants with cancer took part in the study to investigate the psychometric properties of the PSR. The factor structure was examined by using a principal component analysis. Correlations with criteria-related constructs determined the convergent validity. Cut-off scores for the PSR were selected based on receiver-operating characteristics and the calculation of Youden indices. RESULTS: The principal component analysis suggests a two-factor structure: (1) Psychosocial support need to ensure medical and social care services, and (2) Support need for coping with problems. The predicted correlations confirm the convergent validity. Both scales showed excellent internal consistency (Ensure medical and social care services: Omega = 0.94) and (Coping with problems: Omega = 0.90). CONCLUSION: The newly developed scale can provide helpful information regarding psychosocial support needs to professionals (psychotherapists, psychologists, physicians, and social workers) in the psycho-oncological field. Based on this information, specific and personalized interventions for cancer patients can be offered. The PSR is appropriate for assessing specific psychosocial needs to support cancer patients.

Psychometric evaluation of the Positive Mental Health (PMH) scale using item response theory.

BACKGROUND: The investigation of patient-reported outcomes and psycho-oncological interventions mainly focuses on psychological distress or psychopathology. However, the recognition of the equal importance of positive mental health (PMH) has increased lately. The PMH-scale is a brief questionnaire allowing to assess well-being in individuals in the general population and in patients. Previous studies evaluated the psychometric properties of the PMH-scale using classical test theory (CTT). This study is the first to investigate the PMH-scale in patients with cancer using item analysis according to the Rasch model. METHODS: In total, N = 357 cancer patients participated in the study. A Rasch analysis of the PMH-scale was conducted including testing of unidimensionality, local independence, homogeneity and differential item functioning (DIF) with regard to age, gender, type of cancer, the presence of metastases, psycho-oncological support, and duration of disease. Additionally, the ordering of the item thresholds as well as the targeting of the scale were investigated. RESULTS: After excluding one misfitting item and accounting for local dependence by forming superitems, a satisfactory overall fit to the Rasch model was established (χ2 = 30.34, p = 0.21). The new PMH-8 scale proved to be unidimensional, and homogeneity of the scale could be inferred. All items showed ordered thresholds, there was no further item misfit. DIF was found for age, but as the impact of DIF was not substantial, no adjustment related to the age-DIF had to be made. The Person Separation Index (PSI = 0.89) was excellent, indicating excellent discriminatory power between different levels of positive mental health. Overall, the targeting of the PMH-8 was good for the majority of the present sample. However, at both ends of the scale item thresholds are missing as indicated by a slight floor effect (1.4%) and a considerable ceiling effect (9.8%). CONCLUSIONS: Overall, the results of the analysis according to the Rasch model support the use of the revised PMH-scale in a psycho-oncological context.

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

BACKGROUND: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. METHODS: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. RESULTS: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. DISCUSSION: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. TRIAL REGISTRATION: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018.

An item analysis according to the Rasch model of the German 12-item WHO Disability Assessment Schedule (WHODAS 2.0).

PURPOSE: The World Health Organization Disability Assessent Schedule 2.0 (WHODAS 2.0) assesses disability in individuals irrespective of their health condition. Previous studies validated the usefulness of the WHODAS 2.0 using classical test theory. This study is the first investigating the psychometric properties of the 12-items WHODAS 2.0 in patients with cancer using item analysis according to the Rasch model. METHODS: In total, 350 cancer patients participated in the study. Rasch analysis of the 12-items version of the WHODAS 2.0 was conducted and included testing unidimensionality, local independence, and testing for differential item functioning (DIF) with regard to age, gender, type of cancer, presence of metastases, psycho-oncological support, and duration of disease. RESULTS: After accounting for local dependence, which was mainly found across items of the same WHODAS domain, satisfactory overall fit to the Rasch model was established (χ2 = 36.14, p = 0.07) with good reliability (PSI = 0.82) and unidimensionality of the scale. DIF was found for gender (testlet 'Life activities') and age (testlet 'Getting around/Self-care'), but the size of DIF was not substantial. CONCLUSION: Overall, the analysis results according to the Rasch model support the use of the WHODAS 2.0 12-item version as a measure of disability in cancer patients.

The significance of the Interpersonal-Psychological Theory of Suicide in an oncological context-A scoping review.

OBJECTIVES: Since individuals afflicted with cancer are at an elevated risk of dying by suicide, understanding suicide-related ideation and behaviours is critical in identifying vulnerable patients. The interpersonal theory of suicide (IPTS) provides a framework to research risk factors for suicide and has been validated in different samples. The aim of this scoping review is to study literature related to IPTS and cancer patients. METHODS: This scoping review was registered with the OPEN Science Framework (osf.io/92465). The databases PsycINFO, Web of Science, PubMed and PubMed Central were searched. Eligible research needed to use a minimum of one psychometric element to measure at least one of the factors of the IPTS in individuals with cancer. RESULTS: Ninety-six studies were identified and screened. Eligible research included individuals with cancer and the use of at least one measurement of at least one of the factors of the IPTS. Overall, four articles met the inclusion criteria and three studies found significant associations of components of the IPTS and suicidal ideation/behaviour. CONCLUSION: While these initial findings support the notion that the IPTS is relevant for individuals with cancer as well, a direct validation of the IPTS in cancer patients is needed.

Critical consideration of assessment methods for clinically significant changes of mental distress after psycho-oncological interventions.

OBJECTIVES: Considering the heterogeneity of cancer entities and the associated disease progression, personalized care of patients is increasingly emphasized in psycho-oncology. This individualization makes the use of measurements of individual clinically significant change important when studying the efficacy and effectiveness of psycho-oncological care. Two conceptualizations for the measurement of clinical significance are critically contrasted in this study: the Reliable Change Index (RCI) and the Minimal Important Difference (MID) method. METHODS: In total, 2,121 cancer patients participated in the study and a subsample of 708 patients was reassessed about 4 months later. Psychological distress was measured using the Hospital Anxiety and Depression Scale. We evaluated two measures of clinical significance (RCI, MID) by comparing the respective numbers of improved, unimproved, and deteriorated patients. RESULTS: Individually significant changes were observed with both methods; however, determined rates of improvement differed substantially: MID (66.67%) and RCI (48.23%). Most importantly, according to MID, 17.93% of patients were identified as being improved, although their respective improvements were not statistically significant and thus unreliable. CONCLUSIONS: The benefits of RCI outweigh MID, and therefore, the RCI is recommended as a measure to assess change.

Interference Between Family Caregivers' Mental Disorders and Their Estimates of Quality of Dying and Death (QODD) of Their Loved Ones.

BACKGROUND: In studies enrolling informal caregivers of patients in palliative care, it is necessary to ensure that findings are not influenced by factors such as mental disorders. AIM: This study aims to describe the influence of anxiety and depression on bereaved informal caregivers' retrospective ratings of the quality of dying and death (QoDD) of their loved ones. DESIGN: Informal caregivers of deceased patients from 2 German palliative care (PC) units took part in a validation study of the German version of the original QoDD-Deutsch-Angehörige (QoDD-D-Ang) during the fourth week following the patient's death at the earliest. Depressive and panic disorders were assessed via the Patient Health Questionnaire (PHQ). Group comparisons (χ2, t test; significance level P < .05) analyzed whether informal caregivers with depression or panic disorders and those without such disorders differ in their estimates. RESULTS: A total of 226 informal caregivers participated between August 2012 and December 2013. The mean age of participants was 55.5 years; 61.1% were female. The PHQ of 221 participants resulted in 8.6% with major disorders, 13.6% with other depressive syndromes, and 77.8% without depressive disorders. In this secondary data analysis here, there was no difference between female and male participants concerning the incidence of depression ( P = .519, χ2). Two participants screened positive for both panic and major depressive disorders. Both groups presented no significant differences in the mean total QoDD-D-Ang scores ( P = .343). CONCLUSION: Informal caregivers' estimates on the QoDD-D-Ang of their significant others do not interfere with mental disorders. Therefore, bereaved informal caregivers are able to participate in the PC research after a few weeks following the loss of a loved one.

Validation of the German Version of the Quality of Dying and Death Questionnaire for Health Professionals.

PURPOSE: To validate the Quality of Dying and Death (QoDD) instrument for health professionals (QoDD-D-MA) and to test its feasibility in 2 German palliative care units (PCUs). METHODS: The QoDD was translated from English to German and then retranslated following European Organisation for Research and Treatment of Cancer (EORTC) guidelines. Data were collected in 2 German PCUs to calculate aspects of validity and reliability. RESULTS: Mean total score was 83.05 (range 49-100; N = 232). The QoDD-D-MA showed satisfactory psychometric properties, Cronbach α = .830; interrater reliability r = .245 (P < .01). The QoDD-D-MA was independent of patients' demographic and clinical aspects. Some challenges occurred when applying the instrument. CONCLUSIONS: Feasibility could be improved by adapting the QoDD-D-MA to create a self-assessment version and finding a solution for items that result in many missing data. Future research should validate the QoDD-D-MA in other care settings.

Validation of the German Version of the Quality of Dying and Death Questionnaire for Informal Caregivers (QODD-D-Ang).

CONTEXT: The quality of dying and death (QOD) influences end-of-life care for patients and their relatives. To the best of our knowledge, there are currently no validated standard instruments for evaluating the QOD of patients in palliative care units (PCUs) in Germany. OBJECTIVES: This study aimed to validate the German version of the multidimensional questionnaire "Quality of Dying and Death" for informal caregivers (QODD-Deutsch-Angehörige [QODD-D-Ang]) and provide a detailed report on its validity and reliability. METHODS: The QODD was forward/backward translated following the European Organization for Research and Treatment of Cancer guidelines. Data collected in two German palliative care units (N = 226) with the QODD-D-Ang were used to calculate the QODD-D-Ang total score (TS) and to define reliability and validity, as well as acceptance and burden for informal caregivers. Frequencies, means, and SDs of various patient data related to care and disease were calculated to describe the study population and to look at group differences. RESULTS: The mean TS of 175 participants was 75.72 (range 38-99; minimum 0 to maximum 100; higher scores indicate better QOD). The QODD-D-Ang showed good internal consistency for 27 items (Cronbach's alpha 0.852). Factors extracted by factor analysis could not be usefully interpreted. The TS of the QODD-D-Ang correlated substantially with the Palliative care Outcome Scale (r = 0.540), indicating good convergent validity. The QODD-D-Ang TS was stable for various demographic and clinical dimensions except for the amount of days on which informal caregivers visited patients, and, therefore, provided good discriminant validity. CONCLUSION: Analyses of validity and reliability of the QODD-D-Ang showed satisfactory to good psychometric properties, meaning that the QODD can be recommended for standard implementation in German hospices and palliative care institutions to measure the QOD. Feasibility could be improved by adapting the instrument so that it may be administered with minimal demands on staff. When interpreting the results, it should be kept in mind that the QODD-D-Ang does not measure quality of care but the quality of the dying process as estimated by bereaved relatives.

End-of-life care research with bereaved informal caregivers--analysis of recruitment strategy and participation rate from a multi-centre validation study.

BACKGROUND: One essential element of research is the successful recruitment of participants. However, concerns are obvious regarding the ethical implications of involving terminally ill and even dying patients and their informal caregivers as research participants. This study aims to illustrate central issues encountered when recruiting bereaved informal caregivers for a questionnaire validation study on the quality of dying and death. METHODS: Between July 2012 and November 2013, informal caregivers of deceased inpatients who were treated at two palliative care units in Germany were invited to participate in a questionnaire validation study. Informal caregivers were called by a trained researcher at the end of the fourth week after death at the earliest and by the sixteenth week after death at the latest and asked to participate in a face-to-face interview in their private home. RESULTS: The overall participation rate of all eligible informal caregivers was 76.1% (226/297). The mean burden score was 2.5 (NRS from 0=no burden to 10=maximum burden; n=221). Higher burden scores (≥4) were associated with emotional and burdensome memories (n=34) being invoked throughout the interview. Severe or maximum burden scores (≥7) were stated by 13.2% of participants. The average time between the associated patient's death and the informal caregiver's interview was 57.3 days (range 26-176 days, median 49.5 days). 5.3% of all 226 interviews were not completed due to different reasons. Participants' comments on the way in which the study was conducted gave insight into their motivation to take part in the study and their evaluation of the interview situation. CONCLUSIONS: The recruitment strategy can be recommended to other researchers developing research with bereaved carers. The burden caused by study participation was acceptable to the researchers carrying out this research, although a small group of participants experienced high levels of burden which should be anticipated and appropriate support services offered. Family caregivers are willing to support end-of-life care research, have different motivations for participation and even reported benefits from participation. Nevertheless, study designs have to take into account and ease the potential burden of interviews for caregivers experiencing grief.

Support for families of patients dying with dementia: a qualitative analysis of bereaved family members' experiences and suggestions.

OBJECTIVE: To explore and document the needs of family caregivers of patients dying with dementia and to identify how healthcare professionals can adequately support them. METHOD: We employed a cross-sectional survey containing open-ended questions that were analyzed using qualitative methods. RESULTS: Receiving information about the diagnosis and disease trajectory of dementia is essential for the caregiving families of people dying with the disease. However, at present the communication of information offered by professionals is not experienced as satisfying. Further aspects that require improvement concern issues related to time constraints, as well as practical and emotional support from professionals in the care setting. Family members would also like professionals to better assist them during and after the dying process. SIGNIFICANCE OF RESULTS: Family members face multiple burdens while caring for their demented relatives and need more professional support during the course of the disease trajectory as well as in the terminal phase.

Improving end-of-life care in hospitals: a qualitative analysis of bereaved families' experiences and suggestions.

OBJECTIVES: To explore and document the experiences and expectancies of bereaved family members concerning the end-of-life (EOL) care of their deceased relative in a general hospital setting. METHODS: Cross-sectional study using a questionnaire that included open-ended questions. Free-text answers were evaluated with qualitative content analysis. A total of 270 family members provided information about improvements in inpatient care. RESULTS: Families described structural deficiencies. Furthermore, they requested a more holistic patient health care beyond medical treatment and expressed the wish for more professional support for families. DISCUSSION: The view of bereaved families confirmed the need for improvement in general hospital EOL care. The results underline the importance of a more holistic EOL care. The application of communication skills training, structured family meetings, and integrated pathways is recommended.