Conducting a prospective evaluation of the development of a complex psycho-oncological care programme (isPO) in Germany.

BACKGROUND: Evaluating the development phase of a complex intervention programme can be challenging. A prospective evaluation approach is presented based on the example of the new complex psycho-oncological care programme isPO (integrated, cross-sectoral Psycho-Oncology). Prior to programme implementation, we examined (1) if isPO was developed as intended, and (2) if it was relevant and transferable into the newly developed psycho-oncological care networks in North-Rhine Westphalia, Germany. Further, we investigated which implementation facilitators and barriers were anticipated and which implementation strategies were planned by the programme designers (multidisciplinary professionals and cancer supporting organizations who developed the isPO programme components and the networks). METHODS: A mixed-methods approach was applied. Qualitative data were collected by quarterly progress reports, interviews and a focus group with the programme designers. Evaluation criteria for document analyses of the quarterly progress reports were developed and applied. Content analysis was applied for analysing interviews and focus group. Quantitative data were gained from evaluating the programme training for the isPO service providers by short written questionnaires that were analysed descriptively. RESULTS: An implementable prototype of the isPO programme has been developed within 15 months, however no piloting was conducted. The programme's complexity proved to be challenging with regard to coordination and communication of the numerous programme designers. This was intensified by existing interdependencies between the designers. Further, there was little communication and participation between the programme designers and the prospective users (patients and service providers). Due to these challenges, only context-unspecific implementation strategies were planned. CONCLUSION: The required resources for developing a new complex care programme and the need of a mature implementation strategy should be sufficiently addressed. Programmes may benefit from prospective evaluation by gaining insightful knowledge concerning the programme's maturity and anticipating implementation facilitators and barriers. A mixed-methods evaluation design was crucial for achieving profound insight into the development process. TRIAL REGISTRATION: The study has been registered in the German Clinical Trials Register (No. DRKS00015326 ) on 30.10.2018.

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.

A salutogenic model predicting the need for psycho-oncological care and its utilisation-The role of generalised resistance resources and sense of coherence.

OBJECTIVE: Although many cancer patients experience psychological distress, not all affected patients utilise psycho-oncological care. We aim to examine the role of generalised resistance resources (GRRs) and sense of coherence (SOC) in predicting cancer patient needs for psycho-oncological care and its utilisation. A salutogenic prediction model was conceptualised and statistically tested. METHODS: Survey data (response rate 88.94%) from 2270 breast cancer patients one year after treatment in one of 88 certified hospitals in North Rhine-Westphalia, Germany, were analysed. Structural Equation Modelling analysis was performed. RESULTS: 21.6% of patients (n = 485; N = 2249) felt they currently needed psycho-oncological care, of which 61.6% currently utilised it (n = 299, N = 485). 42.2% (n = 953, N = 2259) had the need for psycho-oncological care in the previous 12 months, of which 58.0% (n = 553, N = 953) utilised it. Several GRRs directly predict the need for psycho-oncological care and SOC, as well as indirectly predict the utilisation of psycho-oncological care. Past utilisation significantly affects current need and utilisation. The model shows good model fit. CONCLUSIONS: Generalised resistance resources and SOC affect the utilisation of psycho-oncological care. Therefore, measuring key GRRs and SOC during cancer treatment should be integrated into patient care as a salutogenic approach, to identify resources and vulnerabilities on an individual level.

Development of the health behaviour scale for cancer patients (HBSCP), analysis of its factorial structure and evaluation of its psychometric properties.

OBJECTIVE: The development and validation of a health behaviour scale for cancer patients (HBSCP). METHODS: An 11-item scale was developed based on existing literature on health behaviour and cancer prevention and care. Identified dimensions include the following: nutrition and weight, physical activity, nicotine and alcohol use, stress, and adherence to medical health services. Experts rated the items in regard to content and wording. The scale was tested in two cross-sectional datasets of n = 4626 and n = 4558 newly diagnosed breast cancer patients in North Rhine-Westphalia, Germany. Psychometric properties were assessed (internal consistency, item discrimination, exploratory and confirmatory factor analysis). Correlations with physical functioning (EORTC QLQ-C30) and personality traits (Big Five Inventory) were computed (full assessment of construct validity was not possible). RESULTS: A two-factor structure (1. adherence to medical health services; 2. Individual protective health behaviour) with nine items (item reduction due to findings in the factor analyses) with good item properties and reliability was identified. The scale showed significant associations with physical functioning and the personality traits of conscientiousness. CONCLUSION: The HBSCP is an instrument with good psychometric properties that measures cancer patients' health behaviour. Healthcare providers and researchers can use the HBSCP in the context of health promotion and prevention.

Does basic information concerning nutrition improve the information needs of breast cancer patients? An evaluation.

PURPOSE: International and national studies have shown unmet information needs regarding nutrition in breast cancer patients. An intervention study has examined the question of the extent to which a fact sheet on the topic of nutrition is suitable to cover the need for information of breast cancer patients. METHOD: The fact sheet with basic information on nutrition was distributed in 21 intervention breast care centres in 2017. The use of the fact sheets was evaluated in a quasi-experimental design as part of the annual breast cancer patients' survey of the University of Cologne. The breast cancer patients considered were being treated with primary breast carcinoma in a hospital in North Rhine-Westphalia. A multilevel analysis was carried out in order to quantify the effect of the intervention. RESULTS: Unmet information needs are experienced more by younger and non-native German-speaking patients. With regard to education, patients without a graduation and a high grade of education express more unmet information needs. The multilevel analysis showed that patients who were treated at an intervention site and therefore possibly received the fact sheet have a significantly higher chance of their information needs being met (OR = 1.45; p ≤ 0.05). CONCLUSION: The intervention study showed that a fact sheet with basic information on nutrition is a possible instrument to satisfy the information needs of breast cancer patients and therefore reduce unmet information needs regarding nutrition. This intervention study is a pragmatic example on how to reduce unmet information needs among breast cancer patients in Germany.

Cancer patients' experiences and preferences when receiving bad news: a qualitative study.

PURPOSE: Receiving a cancer diagnosis significantly impacts patients' lives, and how the bad news is delivered influences patients' trajectory, psychosocial adjustment and openness to psycho-oncological support. We explored how patients' experiences, reactions and preferences were when receiving the news and which optimization recommendations can be made. METHODS: We conducted an exploratory qualitative study with patients who enrolled in the new integrated cross-sectoral psycho-oncological care programme 'isPO', being enrolled 12 months post-diagnosis. Data on the main issue (i.e. perception of the moment when the diagnosis is received) were collected via telephone interviews that were fully audiotaped and transcribed. Two independent coders conducted inductive content analyses using MAXQDA. RESULTS: Out of 38 approached patients, 23 cancer patients with 13 different tumour entities participated. They had a mean age of 54.2 (SD 16.2); n = 17 (74%) were female. Three major themes with 14 corresponding subthemes emerged: (1) patients' experiences with the bad news delivery, including setting, mode, preparation and perceived needs; (2) patients' reactions to the bad news, such as shock, fear and helplessness, disbelief and denial, anger and feeling of injustice, thankfulness and depression; and (3) patients' receiving preferences, including psycho-oncological support, addressing informational needs, needs-driven comprehensive support and a competent multidisciplinary support team. CONCLUSIONS: The quality of bad news delivery and addressing patients' needs should be strongly considered by physicians. We recommend integrating patients' perspective on the quality management processes of breaking bad news. For providing needs-centred high-quality care, applying existing guidelines and acquiring patient-centred communication skills are central.

Salutogenesis at Work as a Facilitator for Implementation? An Explorative Study on the Relationship of Job Demands, Job Resources and the Work-Related Sense of Coherence within a Complex Healthcare Programme.

BACKGROUND: The implementation of complex healthcare programmes can be challenging for respective service providers (SPs) in implementation settings. A strong work-related sense of coherence (Work-SoC) promotes creation of job resources and potentially facilitates coping with demands that may arise during implementation. In this study, we analyse how SPs' Work-SoC is influenced by job resources and demands during programme implementation and identify relevant implementation strategies to ensure a salutogenic implementation process. METHODS: Qualitative data were collected during the implementation of a new complex psycho-oncological care programme called isPO. Four focus groups and four interviews were conducted with SPs. All were audiotaped, transcribed and content analysis was applied, whilst ensuring inter- and intra-rater reliability. RESULTS: Each Work-SoC component was influenced by specific job resources and demands. In particular, comprehensibility and manageability interacted. Manageability affected assessment of the programme's feasibility. High meaningfulness positively affected the programme's acceptance and overall assessment among SPs. Furthermore, it buffered low manageability and was strongly associated with project identification. CONCLUSION: We found that Work-SoC could be used to assess SPs' work environment, and therefore programme feasibility. It may be worthwhile to use Work-SoC as an implementation outcome or as an indicator for possible programmes.

Optimizing Patient Information Material for a New Psycho-Oncological Care Program Using a Participatory Health Research Approach in Germany.

High-quality patient information material (PIM) is essential for patients´ informed decision-making, and its quality may influence a care program's acceptance. In the new psycho-oncological care program, isPO, the initial PIM was developed top-down and required optimization. In this paper, we report on the process and experiences of optimizing PIM's quality bottom-up by applying a Participatory Health Research (PHR) approach. Cancer-patient representatives of the national peer-support group contributed as co-researchers as part of the optimization team. A mixed-methods design was chosen. First, the quality of the initially utilized PIM was assessed with the newly designed user-friendly instrument UPIM-Check. Next, three Participatory Action Research loops were conducted, including cancers survivors and isPO service providers. The initial isPO PIM's were assed to be of low quality, limited usability and incomplete. Bottom-up generated optimization suggestions led to the improvement of two initially used PIMs (leaflet, patient information folder) and the design of two new PIMs (poster, study information overview). The optimized PIM facilitates isPO service providers' care provision and helps newly diagnosed cancer patients in understanding and accepting the new program. PIM optimization benefited from applying PHR. The patient representatives' contribution and active patient engagement were central for quality assessment and designing needs-driven, mature and complete PIM.

Participatory Development and Preliminary Psychometric Properties of the User-Friendly Patient Information Material Checklist (UPIM-Check).

The aims of this study were (1) to design a user-friendly instrument to assess and optimize patient information material (PIM), (2) to develop an English version, and (3) to test its psychometric properties. The instrument was needed to optimize the top-down developed PIM of the psycho-oncological care programme isPO. First, a literature-based PIM checklist was developed by a team of patient representatives, cancer care experts and professional researchers. Next, the checklist's reliability and validity were analysed by having cancer survivors assess the initial and optimized version of the isPO-leaflet. The User-friendly Patient Information Material Checklist (UPIM-Check), developed participatorily, was found to be effective for evaluating PIM. It uses a traffic light scale, and suggestions for improvement can be given for each criterion. Its reliability appeared to be excellent (α = 0.927). The optimized leaflet was rated significantly better than the initial one. The UPIM-Check is a reliable and valid instrument, which enables end-users (e.g., patients) to assess and optimize the quality of PIM according to scientific criteria and the needs of end-users. A bottom-up approach was essential for developing and validating the UPIM-Check. End-users constantly contributed with their specific knowledge. Thus, their position as co-researchers was significantly strengthened.

Why do newly diagnosed breast cancer patients seek a second opinion? - Second opinion seeking and its association with the physician-patient relationship.

OBJECTIVE: To examine breast cancer patients' reasons to seek a second opinion (SO) and the underlying variables. To find out more about the outcome of the SO, the perceived helpfulness and the effect on the physician-patient relationship. METHODS: In 2017, 4626 newly diagnosed breast cancer patients from 86 hospitals in Germany completed a postoperative mail survey (response rate = 89.04%). Data from 419 SO-seeking patients was obtained and analyzed by conducting logistic regression and non-parametric group comparisons. RESULTS: Reasons to seek an SO were mostly unrelated to the physician-patient relationship. Reasons related to the physician-patient-relationship were associated with a lower education level. The SO mostly (72.2%) equaled the first opinion. A different treatment plan recommendation (25%) reportedly affected the patients' relationship with their primary physician. Patients who received a different diagnosis reported more fear of progression. Most patients found the SO helpful. CONCLUSION: The reasons to seek an SO are primarily unrelated to the physician-patient relationship. However, less educated patients seem to have different reasons to seek an SO. These reasons were reportedly associated with the physician-patient relationship. PRACTICE IMPLICATIONS: Physicians may need to explicitly ascertain the patient's needs within the physician-patient communication to avoid inequalities based on patient education.