Toward implementation of an evidence-based intervention for fear of cancer recurrence: Feasibility in real-world psycho-oncology practice.

OBJECTIVE: Few evidence-based interventions addressing high levels of fear of cancer recurrence (FCR) have been implemented. Understanding how these might be implemented is crucial to bridge the research-practice gap. This study investigated the feasibility of implementing the blended Survivors' Worries of Recurrent Disease (SWORD) intervention in real-world psycho-oncology practice. METHODS: SWORD was offered for 15 months (2021-2022) as the standard care for clinical FCR in a university hospital, a general hospital, and psycho-oncological center. We evaluated using a mixed-methods design six feasibility outcomes based on Bowen's framework: demand, limited effectiveness, degree of execution, acceptability, practicality, and integration. Anonymous data were collected for all oncology patients on referral. Study participants completed questionnaires before and after treatment, including the Cancer Worry Scale (CWS-6) as the primary measure of effectiveness. Qualitative data included interviews with patients and psychologists, and field notes. RESULTS: Regarding demand, 81 of 644 patients referred (13%) were eligible for SWORD. The uptake of SWORD was 79% (n = 63/80) and the completion rate 73% (n = 46/63). SWORD was effective in reducing FCR (p < 0.001, ηp2  = 0.694). Regarding execution, a variability in the length, planning and number of treatment sessions was found between different settings. Adherence to the treatment manual's content was high (89%). Regarding acceptability, most patients were satisfied with SWORD (average 8.2/10) and psychologists valued the blended format. Psychologists reported SWORD was practical to deliver given their knowledge and skills. Although differences between settings were found, SWORD integrated well into practice. Referral for FCR and a reluctance to contract new eHealth providers were barriers for implementation. CONCLUSIONS: Despite differences between healthcare settings, the implementation of SWORD was evaluated well. The feasibility of SWORD in different settings should inform a national implementation strategy.

Implementation science and psycho-oncology: Advancing the translation of evidence into practice.

OBJECTIVES: This Special issue of Psycho-Oncology highlights examples of the application of implementation science to research in psycho-oncology. The aim is to demonstrate the different ways that implementation science is being used to generate evidence that can more readily translate evidence into changes in clinical practice. We hope this issue fosters greater interest in using the tools of implementation science to improve the lives of people affected by cancer. METHODS: The papers in the issue were selected from among those that responded to a call for submissions on the application of implementation science frameworks and methods to issues in psycho-oncology. The focus included but was not limited to research on: understanding barriers and facilitators of intervention/practice adoption; assessing implementation outcomes, evaluating implementation strategies, and improving behavioural and/or clinical outcomes. RESULTS: The 11 papers in this issue were grouped for presentation purposes into four common topics: barriers and facilitators to implementation; feasibility as a key implementation outcome; the design, selection and adaptation of implementation strategies; and building the foundation for psycho-oncology research translation via systematic reviews that focus on implementation strategy design. CONCLUSION: These papers demonstrate the breadth of current applications of implementation science to research in psycho-oncology. Alongside the studies featured in this issue, including cost-effectiveness analyses, tests of nationally-focused strategies and proactive planning for adaptation, we look forward to other innovations that will promote further growth of both disciplines to improve the integration of psycho-oncology interventions across healthcare systems.

Global trends in psycho-oncology research investments 2016-2020: A content analysis.

OBJECTIVE: An estimated one-third of cancer patients experience a clinically significant psychological disorder, however it is unclear to what extent this is reflected in research funding. To address this a systematic analysis the allocation of psycho-oncology research funding globally between 2016 and 2020 was conducted. METHODS: A global dataset of 66,388 cancer research awards, from 2016 to 2020 inclusive and totalling $24.5 billion USD was assembled from public and philanthropic funders. Each award was previously categorised by cancer site type and research theme, including psychosocial research and these awards were further sub-categorised for this analysis. RESULTS: There was $523m of funding awarded for psychological research across 1122 studies: 2.14% of all cancer research funding during this period ($24.5 billion). Median funding per award was $97,473 (IQR $36,864 - $453,051). Within psychological research, mental health received most funding ($174m, 33.5% of psychological funding). Cognitive behavioural therapy (CBT) focused research was the specific psychological support with the highest proportion of funding at $14 million. By country of funder, the USA provided most investment ($375.5 m, 71.8%). CONCLUSIONS: Psycho-oncology research received relatively little funding, for example, when compared with pre-clinical cancer research. There needs to be a shift from pre-clinical science to research that benefits cancer patients in the shorter-term. Low- and middle-income countries, and ethnic minorities in higher-income settings, were underrepresented despite having a large cancer burden, indicating inequities that need to be addressed.

Core-curriculum in psycho-oncology: Towards the certification of the psycho-oncologist profession.

BACKGROUND: Issues relating to certification of the Psycho-oncology profession require clarification in order to provide high quality comprehensive psychosocial care within oncology. We conducted a survey identifying existing training, professional registration requirements and accreditation programs, at national levels, for the specialty of psycho-oncology as well as the mandatory presence of this specialist in cancer teams. METHODS: This survey was conducted within the International Psycho-Oncology Society Federation of psycho-oncology societies and included representatives of each national federated society and some countries not belonging to the Federation. Survey questions were emailed requesting specific details, from the registered contact person, for each country, about psycho-oncology training, professional registration and accreditation. RESULTS: Of 43 countries contacted (34 Federated and 9 non-federated members), 39 replied and answered the questionnaire (90, 7%). Disparities were reported between countries, with details indicating differences from having no national program, to quite detailed and legally accredited requirements. The majority of countries had no formally recognized profession of "Psycho-oncologist," while some countries reported that it is mandatory (or recommended to have) a specialist in psycho-oncology in cancer centers and, thus, that an accredited, nationally recognized and certified training in this specialty exists. CONCLUSIONS: The study underlines the need to create a curriculum for the specialty (certification and accreditation) for the profession of psycho-oncology. Given the lack of internationally recognized core standards, ideas and proposals for minimum standards of good care and the training required to deliver this, are explored to clarify who may use the designation "Clinical Psycho-oncologist."

Psychosocial and palliative care in African national cancer control plans: A qualitative study.

OBJECTIVE: Low and middle income countries of Africa account for a disproportionate amount of the global health burden of cancer. Providing patients access to psychosocial oncology and palliative care through policy structures such as the National Cancer Control Plans (NCCP) is essential to improving the care provided to patients and their families. The first phase of this study sought to determine the extent to which palliative care and psychosocial oncology were integrated in NCCPs in African countries. METHODS: A qualitative thematic analysis of the plans was used using Nvivo, with two-raters coding and continuous team discussions. Data were organized into an infographic map showing the coverage of themes across African countries. RESULTS: Fifty-eight NCCPs and NCD plans were analyzed in the 54 countries in Africa. The findings illustrate a lack of standardization across countries' NCCPs in addressing psychosocial oncology and palliative care themes. Certain areas presented good coverage across several plans, such as barriers to access, education, awareness, and health behaviors, coordination of care, families, caregivers and community involvement, and palliative care. Other themes presented low coverage, such as doctor-patient communication, mental health, bereavement, psychosocial care, survivorship care, and traditional medicine. CONCLUSIONS: One may consider further developing NCCP areas as they pertain to psychosocial oncology and palliative care to ensure their proper place on the policy agenda for a healthier Africa.

Psychiatric disorders in older adults with cancer referred to psycho-oncology service in a tertiary care cancer centre: a 7-year real world experience from India.

BACKGROUND: Cancer affects mental health in older adults with cancer (OAC), affecting almost 50% of the patients. There are only a few studies on psychiatric disorders in OAC, especially in low resource settings. We report on our real-world experience of prevalence of and factors associated with psychiatric disorders in OAC referred to a psycho-oncology service in an Indian tertiary care cancer institute. METHODS: We retrospectively analysed medical and psycho-oncology records of patients aged 60 + on cancer-directed treatment or follow-up for < 2 years after treatment completion, referred to psycho-oncology services in a tertiary care cancer centre in Mumbai, India, from Jan 2011-Dec 2017. We recorded sociodemographic, clinical, and treatment-related variables, as well as past psychiatric disorders. The ICD-10 was used to record current psychiatric disorder type and presence. IBM SPSS version 24 (Armonk, NY, USA) was used for descriptive measures, tests of association, and logistic regression analysis. The study protocol was approved by Institutional Ethics Committee and registered with the Clinical Trials Registry-India (CTRI/2020/06/026095). RESULTS: Of 763 patients included in the study, 475 (62.3%) were males and 436 (57.1%) were inpatients, with a median age of 65 years. 93% of the patients had a solid tumour and 207 (27.1%) had a history of psychiatric disorder. A current psychiatric diagnosis was noted in 556 patients (72.9%) on initial presentation, of which adjustment disorders, delirium and depression and anxiety disorders were most frequently seen in 25.2%, 21% and 11.1%, respectively. On univariate analysis, a past history of psychiatric disorders (χ2 = 34.6, p < 0.001), lower performance status (χ2 = 9.9, p = 0.002) and haematolymphoid malignancy (χ2 = 4.08, p = 0.04) significantly increased the risk of current psychiatric diagnosis. Logistic regression confirmed these variables as significant. CONCLUSION: Older adults with cancer referred to psycho-oncology services have high rates of psychiatric disorders at their initial presentation, mainly adjustment disorders, delirium and depression and anxiety. A past history of psychiatric disorders, lower performance status and haematolymphoid cancers significantly increased the risk of psychiatric disorders. Multidisciplinary psycho-oncology teams including a psychiatrist should be integrated in comprehensive care of this group of patients. Further research outcomes and effect of psycho-oncological interventions is required in older adults with cancer in LMIC settings.

Does the mode of care delivery affect therapeutic alliance, patient care satisfaction or patient reported outcomes? Psycho-oncological care evaluation data collected during the COVID-19 pandemic.

PURPOSE: Since the COVID-19 pandemic, psycho-oncological care has increasingly been provided virtually and/or telephonically. We examined whether patients' therapeutic alliance (TA) - an essential processual outcome - differs due to altered modes of care delivery (MOCD) and assessed, if MOCD impacts patients' care satisfaction and patient reported outcomes. METHODS: Survey and documentation data from newly diagnosed cancer patients that were cared for in the new form of care 'isPO' in Germany, were analyzed. Patients were surveyed after completing the one-year psycho-oncological care program. MOCD was operationalized by the ratio of patients' face-to-face, telephonic or video-based consultations to all their consultations. Regression analyzes were conducted to determine a possible relationship between MOCD and TA, between MOCD and patients' care satisfaction ('subjective effectiveness' and 'satisfaction and needs-orientation') and patient reported outcomes (anxiety and depression, sense of coherence, global health status). FINDINGS: MOCD does not significantly influence TA. Regression models on the possible effect on subjective effectiveness and satisfaction and needs-orientation do not show statistical significance with only MOCD as the predictor. MOCD does not predict any of the patient reported outcomes. CONCLUSIONS: During the pandemic, neither TA, care satisfaction nor patient reported outcomes were affected by the MOCD in the new form of care 'isPO'. Therefore, the MOCD didn't negatively affect quality of care, which indicates that telephone or video consultations seem to be useful alternatives for psycho-oncological care in Germany.

Psychosocial outcomes in long-term Dutch adult survivors of childhood cancer: The DCCSS-LATER 2 psycho-oncology study.

BACKGROUND: This study compares a comprehensive range of psychosocial outcomes of adult childhood cancer survivors (CCS) to general population-based references and identifies sociodemographic and medical risk factors. METHODS: CCS from the Dutch Childhood Cancer Survivor Study (DCCSS)-LATER cohort (diagnosed 1963-2001) part 2 (attained age ≥18 years, diagnosed <18 years, ≥5 years since diagnosis) completed the Rosenberg Self-Esteem Scale, Hospital Anxiety and Depression Scale, Distress Thermometer, Self-Rating Scale for Post-Traumatic Stress Disorder, and the Short Form-36 (Health Related Quality of Life). CCS' scores were compared with references using analysis of variances and logistic regression analysis, controlling for age and sex (p < .05). Risk factors for worse psychosocial outcomes were assessed with regression analyses (p < .05). RESULTS: CCS, N = 1797, mean age 35.4 years, 49.0% female, all ≥15 years since diagnosis, participated. Three percent reported posttraumatic stress disorder because of childhood cancer and 36.6% experienced clinical distress. CCS did not differ from references on self-esteem and anxiety but were less depressed (d = -.25), and scored poorer on all health-related quality of life scales, except for bodily pain (.01 ≤ d  ≥  -.36). Female sex, lower educational attainment, not being in a relationship, and being unemployed were negatively associated with almost all psychosocial outcomes. Except for a central nervous system tumor diagnosis, few medical characteristics were associated with psychosocial outcomes. CONCLUSION: CCS appear resilient regarding mental health but have slightly poorer health-related quality of life than references. Sociodemographic characteristics and central nervous system tumors were related to most psychosocial outcomes, but no clear pattern was observed for other medical factors. Future studies should address additional factors in explaining CCS' psychosocial functioning, such as coping, social support, and physical late effects.

Responding to distress in cancer care: Increasing access to psycho oncology services through integrated collaborative care.

OBJECTIVE: Despite increased attention to the utility of collaborative care models for promoting whole-person care in cancer populations, there is a paucity of empirical research testing the impact of these care models on effectively identifying and serving highly distressed cancer patients. This study sought to experimentally test the effectiveness of a year-long collaborative care program on referral rates to psycho-oncology services for patients with moderate to high distress. METHODS: Data for this study consisted of 11,467 adult patients with cancer who were screened for psychosocial distress 6-months prior to, and following, the integrated collaborative care intervention. Psychosocial referral rates pre-, peri- and post- intervention were analyzed. RESULTS: Findings indicated high distress patients were at 3.76 (95% CI [2.40, 5.87]), 5.03 (95% CI [3.25, 7.76]), and 7.62 (95% CI [5.34, 10.87]) times increased odds of being referred during the pre-intervention, peri-intervention, and post-intervention, respectively, when compared to low distress patients, and these differences across time were significantly different (p = 0.04). CONCLUSION: Findings from this study suggest that the successful initiation of a collaborative care model within a comprehensive cancer center contributed to significantly greater referral rates of cancer patients with moderate to high distress to psycho-oncology services. This study contributes to the growing consensus that collaborative care models can positively impact the care of complex medical patients.

Psychosocial care for cancer survivors: A global review of national cancer control plans.

OBJECTIVE: National Cancer Control Plans (NCCPs) are high-level policy documents that prioritise actions to be taken to improve cancer control activities. As the number of cancer survivors grows globally, there is an urgent need to assess whether and how psychosocial care across the cancer care continuum is included in NCCPs. This review aimed to ascertain the extent to which NCCPs referenced psycho-oncology care for cancer survivors in the post-treatment phase. METHODS: NCCPs were obtained from the International Cancer Control Partnership (ICCP) portal (in November 2021) and reviewed in two phases. In Phase 1, all available NCCPs were screened to determine whether they mentioned psycho-oncology or survivorship. In Phase 2, reviewers extracted data from the NCCPs identified in Phase 1 on the degree that each plan articulated objectives/goals to improve psychosocial care in the post-treatment survivorship phase. RESULTS: We screened 237 NCCPs. Of these, initial potential reference to psycho-oncology and survivorship content were identified in 97 plans (41%). In Phase 1, 57/97 (59%) had reference to psycho-oncology or survivorship content within defined criteria. In Phase 2, 27/97 (28%) had little mention of psycho-oncology specifically in survivorship, 47/97 (48%) had some (general or brief) mention, and the remaining 23/97 (24%) had substantial content/specific sections and clearly articulated goals and/or objectives. Common goals for improving psychosocial care in the post-treatment period included building capacity of healthcare professionals, implementing rehabilitation models, and increasing the utilisation of community services. CONCLUSIONS: Most NCCPs did not reference psycho-oncology and only one-quarter contained clear objectives specifically in the post-treatment survivorship phase.

Global Breast Cancer Initiative: A platform to address the psycho-oncology of cancer in low- and middle-income countries for improving global breast cancer outcomes.

BACKGROUND: Psycho-oncology is a clinical specialty in which the humanistic aspects of cancer diagnoses and treatment are addressed to reduce the psychological burden for patients and their caregivers to optimize patient participation, cancer outcomes and quality-of-life, which is especially critical in cultures where cancer is perceived as invariably fatal. Psycho-oncology programs face multiple barriers in low- and middle-income countries, including limited resource allocation and lack of training, both of which have been impediments to psycho-oncology programs becoming recognized as core competencies in cancer management and part of a standard medical curriculum. PURPOSE: This paper discusses the role of the Global Breast Cancer Initiative (GBCI) in helping to overcome inequities in breast cancer care and improve clinical outcomes from a psycho-oncology perspective as a model for improved cancer care in limited resource settings. FINDINGS: GBCI applies a comprehensive framework encompassing all phases of cancer care (defined through three pillars spanning the continuum of cancer management) and includes addressing the physical, psychological, and social needs of women throughout the life-course. Efforts to promote policies that increase access to early detection and treatment programs and improve health literacy among the public are important strategies to mitigate the most common emotional and physical challenges reported by people with cancer accessing care. CONCLUSIONS: Future efforts will focus on the integration of culturally appropriate guidance to promote early cancer detection and treatment completion through training programs for clinicians to establish core competencies in psycho-oncology. Emerging advocacy efforts in the oncology arena may help guide the integration of psycho-oncology services into routine care in countries where these services are not already integrated into the standard curriculum.

Psychosocial functioning of adult siblings of Dutch very long-term survivors of childhood cancer: DCCSS-LATER 2 psycho-oncology study.

OBJECTIVE: To describe psychosocial outcomes among adult siblings of very long-term childhood cancer survivors (CCS), to compare these outcomes to reference populations and to identify factors associated with siblings' psychosocial outcomes. METHODS: Siblings of survivors (diagnosed <18 years old, between 1963 and 2001, >5 years since diagnosis) of the Dutch Childhood Cancer Survivor Study DCCSS-LATER cohort were invited to complete questionnaires on HRQoL (TNO-AZL Questionnaire for Adult's HRQoL), anxiety/depression (Hospital Anxiety and Depression Scale), post-traumatic stress (Self-Rating Scale for Post-traumatic Stress Disorder), self-esteem (Rosenberg Self-Esteem Scale) and benefit and burden (Benefit and Burden Scale for Children). Outcomes were compared to a reference group if available, using Mann-Whitney U and chi-Square tests. Associations of siblings' sociodemographic and CCS' cancer-related characteristics with the outcomes were assessed with mixed model analysis. RESULTS: Five hundred five siblings (response rate 34%, 64% female, mean age 37.5, mean time since diagnosis 29.5) of 412 CCS participated. Siblings had comparable HRQoL, anxiety and self-esteem to references with no or small differences (r = 0.08-0.15, p < 0.05) and less depression. Proportions of symptomatic PTSD were very small (0.4%-0.6%). Effect sizes of associations of siblings' sociodemographic and CCS cancer-related characteristics were mostly small to medium (ß = 0.19-0.67, p < 0.05) and no clear trend was found in the studied associated factors for worse outcomes. CONCLUSIONS: On the very long-term, siblings do not have impaired psychosocial functioning compared to references. Cancer-related factors seem not to impact siblings' psychosocial functioning. Early support and education remain essential to prevent long-term consequences.

Global psycho-oncology in low middle-income countries: Challenges and opportunities.

OBJECTIVES: This Special Issue of Psycho-Oncology is focused on challenges and opportunities in the provision of psychosocial care to patients in low and middle-income countries (LMICs). The aim is to highlight global disparities and inequity in the provision of evidence-based, culturally-sensitive and timely psychosocial care and to showcase the work of researchers and practitioners to address this gap. We hope that this Issue will help to advance the psychological and social dimensions of cancer care in all parts of the world. METHODS: The focus of the papers is on research and clinical innovations in LMICs that target the psychological, social and cultural dimensions of cancer and on interventions to improve or maintain the psychological well-being, social functioning and/or quality of life of those who are affected and their families. RESULTS: These papers draw attention to guidelines, resource needs, clinical service evaluation, emerging research and knowledge translation within LMICs that advance knowledge and implementation in the field of psycho-oncology. CONCLUSIONS: Innovations and advances in psycho-oncology are emerging from LMICs to enhance the care of patients with cancer and their families in these regions and in all parts of the world. A sustained global initiative is now needed to ensure that guidelines for such care are routinely included in global, national and local cancer control plans and that essential resources and attention are directed to implement them.

Black women's distress matters: Examining gendered racial disparities in psycho-oncology referral rates.

OBJECTIVE: Presently, there is a lack of research examining gendered racial disparities in psycho-oncology referral rates for Black women with cancer. Informed by intersectionality, gendered racism, and the Strong Black Woman framework, this study sought to examine the possibility that Black women are adversely affected by such phenomena as evidenced by lower probability of being referred to psycho-oncology services compared to Black men, White women and White men. METHODS: Data for this study consisted of 1598 cancer patients who received psychosocial distress screening at a comprehensive cancer center in a large Midwest teaching hospital. Multilevel logistic modeling was used to examine the probability of referral to psycho-oncology services for Black women, Black men, White women, and White men while controlling for patient-reported emotional and practical problems and psychosocial distress. RESULTS: Results indicated that Black women had the lowest probability of being referred to psycho-oncology services (2%). In comparison, the probability of being referred to psycho-oncology were 10% for White women, 9% for Black men, and 5% for White men. Additionally, as nurses' patient caseload decreased, the probability of being referred to psycho-oncology increased for Black men, White men, and White women. In contrast, nurses' patient caseload had little effect on the probability of being referred to psycho-oncology for Black women. CONCLUSIONS: These findings suggest unique factors influence psycho-oncology referral rates for Black women. Findings are discussed with particular focus on how to enhance equitable care for Black women with cancer.

Use of telehealth for psychosocial oncology: A mixed methods study about barriers to and opportunities with Latino patients from Latin America, Spain, and the United States.

OBJECTIVES: Telehealth for mental healthcare expanded rapidly with the COVID-19 pandemic's onset; however, global access disparities emerged. Telehealth challenges and opportunities for Latino cancer patients from different geographical regions must be explored. METHODS: A cross-sectional online survey (March-July 2021) of mental health providers, serving Latino cancer patients in Latin America, United States, and Spain, contained close-ended questions related to the use of telehealth during the pandemic and open-ended questions on recommending/not recommending telehealth. RESULTS: In a sample of 148 providers from 21 countries, 60.5% reported that at least some of their patients had difficulties with Internet speed and connectivity and lacked knowledge about using electronic devices (43.2%) or the Internet (45.4%). Lacking privacy at home (66.0%) and childcare (26.0%) were reported patient challenges. Internet connectivity or speed were issues for providers (43.2%) themselves. Improving patient reach was a reported telehealth benefit (64.2%). Geographical access (43.2%) and physical limitations (35.8%) were considerations in offering telehealth. Considerations for not recommending telehealth were patient age (24.3%) and lacking technological knowledge (29.1%). CONCLUSIONS: Telehealth for mental healthcare may improve patient access issues caused by geographical and transportation conditions and patient functionality. Findings provide insight into telehealth benefits and challenges in Latino patient populations. Future studies should examine patient access and use by region.

Healthcare providers' perceptions about the unmet needs of their patients with cancer across healthcare systems: results of the International Psycho-Oncology Society survivorship survey.

OBJECTIVE: Systematic understanding of patients' unmet needs is essential for providing effective supportive care. This study sought to compare the unmet needs of patients with cancer identified by health care providers (HCPs) among four major healthcare systems. METHODS: HCPs (n = 247) participated in the International Psycho-Oncology Society (IPOS) Survivorship Online Survey, evaluating their patients' unmet needs. The country of HCPs was grouped into four major healthcare systems: Beveridge model, Bismarck model, National Health Insurance model, and out-of-pocket model. RESULTS: Most HCPs were from countries with the Bismarck model. Substantial levels (> 50%) of unmet needs in all domains are reported across the four healthcare systems. Pediatric patients/survivors living in countries under out-of-pocket healthcare model were evaluated to have less unmet needs for managing decline in physical or cognitive functioning and insomnia/sleep difficulty/fatigue, than those in countries under Beveridge, Bismarck, and National Health Insurance models. Moreover, middle-aged patients/survivors under Beveridge and National Health Insurance models were likely to have greater unmet needs for dealing with cancer-related financial concerns than those under Bismarck model. CONCLUSION: This study provides valuable insights into the unmet needs of patients with cancer in different healthcare systems, highlighting the significance of targeted interventions to address the unique needs of patients across diverse healthcare systems. Further investigation is warranted to identify the system factors associated with patients' unmet needs, enabling the development of effective healthcare policies and interventions to comprehensively address the multifaceted needs of patients with cancer.

The role of integrated psychological support in breast cancer patients: a randomized monocentric prospective study evaluating the Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) program.

PURPOSE: This study examined the effects of Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) in a group of women with breast cancer compared with a group receiving treatment as usual (TAU). METHODS: The research design was a randomized, monocentric, prospective study with three time points of data collection: after the preoperative phase (T0), in the initial phase of treatments (T1), and 3 months after the start of treatments (T2). The FRIPOS group (N = 103) and the TAU group (N = 79) completed a sociodemographic questionnaire, the Symptom Checklist-90-R (SCL-90-R) at T0; the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and EORTC QLQ-BR23 at T1; and SCL-90-R, EORTC QLQ-C30, and EORTC QLQ-BR23 at T2. RESULTS: A series of independent and paired t tests showed that patients in the FRIPOS group performed better on all scales related to symptomatic manifestations and on some quality of life scales (fatigue, dyspnea, and sleep disturbances) at T2. In addition, a series of ten multiple regressions were performed to predict each SCL subscale at T2 from the SCL score at T0 and the EORTC QLQ-C30 scores at T2. In nine of ten regression models (all except somatization), both FRIPOS group membership and QoL subscale contributed significantly to prediction. CONCLUSIONS: This study suggests that patients in the FRIPOS group have more benefits in emotional, psychological, and collateral symptoms than patients in the TAU group and that these improvements are due to integrated psycho-oncology care.

Developing quality indicators for cross-sectoral psycho-oncology in Germany: combining the RAND/UCLA appropriateness method with a Delphi technique.

BACKGROUND: Internationally, the need for appropriately structured, high-quality care in psycho-oncology is more and more recognized and quality-oriented care is to be established. Quality indicators are becoming increasingly important for a systematic development and improvement of the quality of care. The aim of this study was to develop a set of quality indicators for a new form of care, a cross-sectoral psycho-oncological care program in the German health care system. METHODS: The widely established RAND/UCLA Appropriateness Method was combined with a modified Delphi technique. A systematic literature review was conducted to identify existing indicators. All identified indicators were evaluated and rated in a two-round Delphi process. Expert panels embedded in the Delphi process assessed the indicators in terms of relevance, data availability and feasibility. An indicator was accepted by consensus if at least 75% of the ratings corresponded to category 4 or 5 on a five-point Likert scale. RESULTS: Of the 88 potential indicators derived from a systematic literature review and other sources, 29 were deemed relevant in the first Delphi round. After the first expert panel, 28 of the dissented indicators were re-rated and added. Of these 57 indicators, 45 were found to be feasible in terms of data availability by the second round of expert panel. In total, 22 indicators were transferred into a quality report, implemented and tested within the care networks for participatory quality improvement. In the second Delphi round, the embedded indicators were tested for their practicability. The final set includes 16 indicators that were operationalized in care practice and rated by the expert panel as relevant, comprehensible, and suitable for care practice. CONCLUSION: The developed set of quality indicators has proven in practical testing to be a valid quality assurance tool for internal and external quality management. The study findings could contribute to traceable high quality in cross-sectoral psycho-oncology by providing a valid and comprehensive set of quality indicators. TRIAL REGISTRATION: "Entwicklung eines Qualitätsmanagementsystems in der integrierten, sektorenübergreifenden Psychoonkologie-AP "Qualitätsmanagement und Versorgungsmanagement" zur Studie "integrierte, sektorenübergreifende Psychoonkologie (isPO)" a sub-project of the "integrierte, sektorenübergreifende Psychoonkologie (isPO)", was registered in the German Clinical Trials Register (DRKS) (DRKS-ID: DRKS00021515) on 3rd September 2020. The main project was registered on 30th October 2018 (DRKS-ID: DRKS00015326).

Patients' perspectives on the quality of care of a new complex psycho-oncological care programme in Germany - external mixed methods evaluation results.

BACKGROUND: Guideline-compliant provision of psycho-oncological (PO) care is still challenging in Germany. Hence, a new care programme, called integrated cross-sectoral psycho-oncology (isPO), was implemented to improve the integration of needs-oriented PO care. Quality of care (QoC) was externally evaluated from the patient's perspective. We aim to gain insight into patients' experiences with isPO and how their assessment affects relevant patient-reported outcomes (anxiety and depression, health status, and work ability). METHODS: An explanatory, sequential mixed-methods design was applied. Patients were surveyed twice during their 1-year care trajectory: after 3 (T1) and 12 (T2) months. Data sets were matched using pseudonyms. Care documentation data, including sociodemographic characteristics and the primary outcome variable (anxiety and depression), were matched. In the survey, patients rated their satisfaction with respective isPO service providers and the programme in general (QoC). Health status (EORTC-QLQ-C30) and work ability (WAS) were measured. Descriptive analyses and t-tests for dependent samples were conducted to assess changes in outcome variables over time. Linear regression analyses were conducted to assess whether care satisfaction predicted outcome variables. Patients who completed their isPO care trajectory were asked to participate in semi-structured telephone interviews to share their experiences. Purposeful sampling was applied. All 23 interviews were audiotaped, transcribed, and analysed via content-structuring method. RESULTS: Patients reported medium-to-high satisfaction with their isPO care. All patient-related outcomes significantly improved over time and QoC measures predicted those outcomes. Needs orientation (e.g., care intensity or mode of delivery) was perceived as essential for high QoC, and outpatient care with fixed contact persons as highly important for care continuity. Furthermore, patients identified programme optimisation needs, such as period of care or extension of care to relatives. CONCLUSIONS: Patients assessed the isPO programme's QoC positively. They identified facilitators for QoC and optimisation needs. Therefore, data on QoC can function as an indicator for a programme's feasibility and maturity within care reality. As patients' care satisfaction positively influences important patient-related outcomes, it may be routinely considered for quality management. Based on patients' perspectives, isPO seems to be recommendable for routine psycho-oncological care in Germany, if ongoing programme optimisation within structured quality management is guaranteed. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (No. DRKS00015326) on 30.10.2018.

The impact of COVID-19 on the interpretation of psycho-oncological support trial results: a quasi-experimental approach using the data from the new form of care "Integrated cross-sectoral psycho-oncology (nFC-isPO)".

OBJECTIVE: In addition to the common difficulties of ongoing trials, the COVID-19 pandemic posed several challenges to scientists worldwide and created an additional burden for vulnerable patient groups. In the nFC-isPO of individualised treatment for anxiety and depression in newly diagnosed patients with cancer caregivers (e.g. psycho-oncologists) reported elevated HADS scores in newly enrolled patients after the outbreak of the COVID-19 pandemic. Accordingly, the question arises whether the pandemic affected HADS scores. Therefore, stratified analyses by the time of enrolment (T1) were performed for patients with 12 months of care (T3). METHODS: Patients with 12 months of care (N = 1,140) were analysed. A comparison within the regression discontinuity design according to the time points at which patients completed the baseline (T1) HADS questionnaire was conducted to examine differences between patients recruited before Q2/2020 (pre-pandemic) and after the coronavirus outbreak. Furthermore, mean HADS scores at T1 and T3 for all quarters during the study were compared. RESULTS: Mean T1 and T3 HADS scores of patients with cancer during the pandemic are only slightly higher than those of the pre-pandemic group. No significant treatment effect was observed in either the pre-pandemic (p = 0.5495, Late = 1.7711) or the post-pandemic group (p = 0.9098, LATE=-0.2933). In contrast, the average local treatment effect in the post-pandemic group suggests a minimal decrease in HADS score in the predefined range and thus a positive treatment effect for isPO. Comparison of mean HADS scores at T1 and T3 did not show a large increase by pandemic-related timepoints, however, a decrease of approximately 2-3 points over each quarter at 12 months compared to baseline is observed. CONCLUSION: The existing nFC-isPO care is resilient to crisis and may counteract external influences such as the Corona pandemic. Accordingly, the pandemic had little influence on the fears of patients with cancer in the nFC-isPO. This emphasises that psycho-oncology is vital for the reduction of stress, anxiety and depression in patients with cancer. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry on 30 October 2018 under the ID "DRKS00015326".